UK Medical Device Regulation Post-Brexit: UKCA Marking, MHRA & The Complete Guide

Why UK Medical Device Regulation Demands Your Attention Now

On 31 January 2020, the United Kingdom left the European Union. On 31 December 2020, the Brexit transition period ended, and the UK ceased to be part of the EU single market. For medical device manufacturers, that single date created a new regulatory jurisdiction — one that is still actively building its framework, making real-time policy decisions, and diverging from the EU system it once belonged to.

If you manufacture medical devices or in vitro diagnostics and sell them — or plan to sell them — in the United Kingdom, you are now dealing with a standalone regulatory regime governed by the Medicines and Healthcare products Regulatory Agency (MHRA). The rules are not the same as the EU MDR. They are not a simple copy-paste of the old EU directives either. The UK is charting its own path, and that path has shifted significantly since Brexit, with multiple consultations, policy reversals, and timeline extensions between 2021 and 2026.

This guide covers the current state of UK medical device regulation as of early 2026: the legal framework, device classification, the UKCA marking, CE marking recognition, the UK Responsible Person requirement, Northern Ireland's unique position, registration with the MHRA, clinical investigations, post-market surveillance, software and AI regulation, IVD-specific requirements, fees, recent developments, and practical guidance for manufacturers — whether you are already CE marked, US-based, or entering the UK market for the first time.

The MHRA: UK's Standalone Regulator

From EU Member State to Independent Authority

Before Brexit, the UK operated under the EU regulatory framework. The MHRA was a Competent Authority under the EU Medical Devices Directives (MDD, AIMDD, IVDD) and later under the EU MDR and IVDR. UK Notified Bodies — most notably BSI (NB 0086) — were designated under the EU system and could issue CE certificates valid across the entire European Economic Area.

After Brexit, the MHRA became the sole regulatory authority for medical devices placed on the Great Britain market (England, Scotland, and Wales). Northern Ireland operates under different rules, which we cover in detail below.

The MHRA's responsibilities now include:

• Market authorization and registration of medical devices for the UK market
• Designation and oversight of UK Approved Bodies (the UK equivalent of EU Notified Bodies)
• Vigilance and post-market surveillance — receiving and investigating incident reports, field safety corrective actions, and trend reports
• Clinical investigation oversight — reviewing and authorizing clinical investigations conducted in the UK
• Standards and guidance — developing UK-specific guidance documents, adopting or diverging from international standards
• Enforcement — powers to remove non-compliant devices from the market, issue recalls, and take regulatory action against non-compliant economic operators

MHRA's Regulatory Vision

The MHRA has stated its intention to build a regulatory framework that is "at least as rigorous" as the EU MDR but more proportionate, innovation-friendly, and responsive. In practice, this means the MHRA is selectively adopting elements of the EU MDR while deliberately diverging in areas where it believes the EU framework is too burdensome or not well suited to the UK market.

The MHRA's stated priorities include faster access to innovative devices (particularly software, AI/ML, and point-of-care diagnostics), a proportionate approach to legacy devices, and stronger international collaboration — particularly with the FDA, Health Canada, TGA (Australia), and other IMDRF members.

The Current Legal Framework: UK MDR 2002

What Governs Today

The legal basis for medical device regulation in Great Britain today is the Medical Devices Regulations 2002 (SI 2002 No. 618), as amended. This is a UK statutory instrument that originally transposed the EU Medical Devices Directives into UK law. At the point of Brexit, EU law was "onshored" into UK domestic law through the European Union (Withdrawal) Act 2018, and subsequent amendments have been made to adapt the regulations for a standalone UK context.

The key point: the current UK framework is still rooted in the old EU directives (MDD, AIMDD, IVDD), not the EU MDR or IVDR. While the MHRA has been consulting on a comprehensive new framework — and has implemented some changes through amendments to the 2002 Regulations — the wholesale replacement of this framework has been repeatedly delayed.

Key Amendments Since Brexit

The UK MDR 2002 has been amended several times since Brexit to establish UK-specific requirements:

Amendment	Key Changes
Medical Devices (Amendment etc.) (EU Exit) Regulations 2019	Onshored EU directives into UK law; replaced references to EU institutions with UK equivalents
Medical Devices (Amendment) (Great Britain) Regulations 2023	Introduced the UK Responsible Person requirement; extended transitional provisions for CE-marked devices
Medical Devices (Amendment) (Great Britain) Regulations 2024	Further extended CE marking recognition timelines; updated registration requirements and timelines
Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368)	Enacted 16 December 2024; came into force 16 June 2025. Introduced comprehensive PMS requirements: mandatory PMS plans, PMSR/PSUR, 15-day incident reporting, broadened reportable incident scope, MORE portal reporting, GB data schemas
Medical Devices (Amendment) (Great Britain) Regulations 2025	Codified indefinite CE marking recognition for devices meeting specified conditions; updated Approved Body designation criteria

What This Means in Practice

Manufacturers operating under the current framework are working within a regulatory system that is fundamentally based on the MDD/AIMDD/IVDD classification rules, essential requirements, and conformity assessment procedures — but with UK-specific overlays for registration, the UK Responsible Person, and market access.

This creates a unique situation: a manufacturer with a valid CE certificate under the MDD or EU MDR can place devices on the Great Britain market (subject to conditions), while simultaneously a UKCA marking route exists for manufacturers who want or need to certify specifically under the UK system.

UKCA Marking vs. CE Marking: The Current Position

The Original Plan

When Brexit took effect, the UK government announced that the UKCA (UK Conformity Assessed) marking would replace the CE marking for the Great Britain market. The original timeline required all medical devices to carry the UKCA marking by 30 June 2023, after which CE marking would no longer be accepted.

The Repeated Deferrals

That deadline was extended. Multiple times. The reasons were practical: UK Approved Bodies lacked capacity to recertify the tens of thousands of CE-marked devices on the UK market, manufacturers were struggling with dual compliance requirements, and the MHRA recognized that a hard cutoff would cause device shortages.

Timeline of CE marking recognition extensions:

Date	Policy Position
January 2021	UKCA required from 1 July 2023
July 2022	Extended to 30 June 2024
November 2023	Extended to 30 June 2025 for most devices
May 2024	Extended further with category-specific timelines
2025	CE marking recognition made indefinite for devices meeting specified conditions

The Current Position: Indefinite CE Marking Recognition

As of 2026, the UK government has signaled a decisive pivot toward indefinite recognition of CE marked medical devices on the Great Britain market. On 22 July 2025, the government published its response to the 2024 consultation on future routes to market, confirming its intent to accept CE marking indefinitely — abandoning the original requirement for a separate UK-specific conformity assessment. On 16 February 2026, the MHRA formally launched a targeted consultation on the indefinite recognition of CE-marked medical devices, running until 10 April 2026. This consultation complements wider planned reforms expected later in 2026.

MHRA Chief Executive Lawrence Tallon stated: "The number one request that the medtech industry made of us was to provide long-term certainty over CE recognition." Around 90% of devices currently used in Great Britain carry CE marking, which underscores why this policy shift was necessary to protect supply and reduce duplication.

Current Transitional Deadlines (Until Indefinite Recognition Is Formally Enacted)

Until the consultation concludes and legislation is updated, the existing transitional deadlines remain in force:

Device Type	Current GB Deadline
General medical devices compliant with the EU MDD or AIMDD with a valid declaration and CE marking	Can be placed on the GB market up until the sooner of certificate expiry or 30 June 2028
IVDs compliant with the EU IVDD	Can be placed on the GB market up until the sooner of certificate expiry or 30 June 2030
Medical devices (including custom-made) and IVDs with valid CE marking under the EU MDR or IVDR	Can be placed on the GB market until 30 June 2030

The February 2026 Consultation: Three Key Proposals

The MHRA's February 2026 consultation seeks views on three specific proposals:

1. Extending MDD transitional arrangements — Aligning GB timelines with the EU's transition to the EU MDR. This would extend the current 30 June 2028 deadline for MDD-certified devices to 31 December 2028, matching the EU's own transition timeline.

2. Indefinite recognition of EU MDR and IVDR devices — Allowing devices that comply with the EU MDR (2017/745) or EU IVDR (2017/746) to be placed on the GB market indefinitely, with no sunset date. The MHRA is particularly interested in views on whether this should apply to all devices, or only to devices classified at the same or lower risk category under UK MDR as they are under the relevant EU regulation.

3. International reliance route for higher-risk reclassified devices — For a small proportion of CE-marked devices that would fall into a higher risk class under UK MDR 2002 compared to EU rules, the MHRA proposes to introduce an international reliance pathway rather than outright indefinite recognition.

What Indefinite Recognition Means in Practice

Once enacted, indefinite CE recognition will mean:

• No requirement for dual conformity assessment — CE-marked devices will not need a separate UKCA certification or additional review by a UK Approved Body
• UKCA repositioned — The UKCA marking will be refocused as a specialist route for first-in-market innovative products, particularly AI as a medical device, rather than a mandatory replacement for CE marking
• Physical UKCA marking removal planned — The MHRA has announced support for removing the requirement for physical UKCA markings on products and packaging once Unique Device Identification (UDI) requirements are in place, reducing barriers to market entry while strengthening traceability
• UK-specific requirements remain — Manufacturers must still appoint a UKRP, register with the MHRA, comply with UK labeling requirements, and report to the MHRA vigilance system

The conditions for CE marking acceptance in Great Britain are:

• The device must have a valid CE certificate issued by an EU Notified Body (for devices requiring third-party conformity assessment) or a valid EU Declaration of Conformity (for self-declared devices)
• The CE certificate must be current and not expired, suspended, or withdrawn
• The device must comply with the applicable EU directive (MDD, AIMDD, IVDD) or the EU MDR/IVDR, as applicable
• The device must be registered with the MHRA
• A UK Responsible Person must be designated (for non-UK manufacturers)
• The device must meet UK-specific labeling requirements (including English-language labeling)

UKCA Marking: Still an Option

The UKCA marking has not been abandoned. It remains available for manufacturers who choose to certify through the UK system using a UK Approved Body. Some reasons a manufacturer might pursue UKCA marking:

• Strategic UK market commitment — demonstrating dedication to the UK market to customers and NHS procurement bodies
• Devices not CE marked — new devices that have not gone through EU conformity assessment
• Future regulatory divergence — as the UK framework evolves, UKCA-certified devices may benefit from early compliance with UK-specific requirements
• Devices losing CE marking — if a manufacturer's EU certificate expires and is not renewed (for example, due to EU MDR transition challenges), UKCA marking provides an alternative route to the UK market

UKCA Marking Requirements

To apply the UKCA marking, a manufacturer must:

1. Classify the device under the UK MDR 2002 classification rules (which currently mirror the MDD classification rules)
2. Comply with the applicable essential requirements set out in the UK MDR 2002
3. Undergo conformity assessment — either self-declaration (for lower-risk devices) or assessment by a UK Approved Body (for higher-risk devices)
4. Prepare technical documentation in accordance with UK requirements
5. Draw up a UK Declaration of Conformity
6. Register the device with the MHRA
7. Appoint a UK Responsible Person (if the manufacturer is not established in the UK)
8. Affix the UKCA marking to the device

Practical reality: As of early 2026, the vast majority of medical devices on the Great Britain market carry CE marking, not UKCA marking. The indefinite CE recognition has removed the urgency for most manufacturers to pursue UKCA certification. However, manufacturers should monitor MHRA announcements — the planned new UK regulatory framework, once implemented, will establish new requirements that may eventually make UKCA marking (or its successor) mandatory.

UK Approved Bodies

Designation Status

UK Approved Bodies are the UK equivalent of EU Notified Bodies. They are designated by the MHRA to perform conformity assessment of medical devices under the UK MDR 2002. The MHRA maintains the official list at gov.uk, which is updated as designations are added, expanded, or revoked.

As of early 2026, the designated UK Approved Bodies include:

UK Approved Body	AB Number	Scope	Designation Expiry
BSI Assurance UK Ltd	0086	General medical devices, active implantable medical devices, IVDs	1 September 2027
SGS United Kingdom Ltd	0120	General medical devices	See gov.uk listing
TUV SUD BABT Unlimited	0168	General medical devices, active implantable medical devices, IVDs	Medical Devices: 11 August 2028; IVDs: 2 July 2030
Eurofins E&E CML Limited	2503	General medical devices	See gov.uk listing
DEKRA Certification UK Ltd	8505	General medical devices, active implantable medical devices, IVDs	See gov.uk listing
Intertek Medical Notified Body UK Ltd	8532	General medical devices	24 August 2028
Scarlet NB UK Ltd	8536	General medical devices	See gov.uk listing
UL International (UK) Ltd	0843	General medical devices	See gov.uk listing

Note: LNE-GMED UK Limited was previously designated but has ceased UK operations and been removed from the approved list.

Approved Body Capacity: A Growing but Constrained System

While the number of UK Approved Bodies has grown significantly from the initial three (BSI, SGS, and Intertek) to eight as of early 2026, overall capacity remains a constraint compared to the dozens of EU Notified Bodies. BSI remains the dominant UK Approved Body by volume and scope, and is the only body currently designated across all three device categories (general medical devices, active implantables, and IVDs).

The MHRA has actively worked to expand capacity through:

• Streamlining the designation process for new Approved Bodies
• Expanding the scope of existing designations — for example, TUV SUD BABT received IVD designation, and DEKRA received active implantable medical device designation during 2025
• Recruiting additional MHRA device regulatory assessors and building capability in emerging areas

However, with indefinite CE marking recognition now the expected policy direction, the practical pressure on UK Approved Body capacity has eased. Most manufacturers will continue to rely on EU Notified Bodies for conformity assessment, with UK Approved Bodies serving manufacturers who specifically need UKCA certification or who are developing first-in-market products for the UK.

The Dual Role of BSI

BSI presents a unique situation in the post-Brexit landscape. BSI Group operates as:

• BSI Assurance UK Ltd — a UK Approved Body designated by the MHRA for UKCA marking
• BSI Group Netherlands B.V. — an EU Notified Body (NB 2797) designated under the EU MDR and IVDR, operating from the Netherlands

This means BSI can serve manufacturers in both jurisdictions. However, the two entities are legally separate, and a certificate from one does not automatically apply in the other jurisdiction. A CE certificate from BSI Netherlands is valid for the EU market (and accepted in Great Britain under the CE recognition policy), while a UKCA certificate from BSI UK is valid only for the Great Britain market.

UK Responsible Person (UKRP)

The Requirement

Any manufacturer of medical devices that is not established in the United Kingdom must designate a UK Responsible Person (UKRP) before placing devices on the Great Britain market. This requirement was introduced through the Medical Devices (Amendment) (Great Britain) Regulations 2023 and is now fully in force.

The UKRP requirement applies to:

• Non-UK manufacturers (whether established in the EU, US, or any other country)
• All device types: general medical devices, active implantable medical devices, and IVDs
• All risk classes

UKRP Responsibilities

The UKRP must be a natural or legal person established in the United Kingdom. Their responsibilities include:

• Registration: Ensuring the device and manufacturer are registered with the MHRA
• Declaration of Conformity and technical documentation: Maintaining a copy of the UK Declaration of Conformity (or EU Declaration of Conformity, as applicable) and ensuring the manufacturer's technical documentation is available to the MHRA on request
• Regulatory correspondence: Acting as the point of contact for the MHRA on matters relating to the devices they represent
• Vigilance cooperation: Cooperating with the MHRA on vigilance matters, including forwarding incident reports, field safety corrective actions, and trend reports
• Post-market surveillance cooperation: Supporting the manufacturer's post-market surveillance obligations as they relate to the UK market
• Compliance verification: Verifying that the manufacturer has met the applicable conformity assessment requirements for the devices to be placed on the UK market

UKRP vs. EU Authorized Representative

The UKRP role is analogous to the EU Authorized Representative (Article 11 of the EU MDR) but is a separate legal requirement. A manufacturer needs both if it places devices on both the EU and UK markets.

Aspect	UK Responsible Person (UKRP)	EU Authorized Representative
Legal basis	UK MDR 2002 (as amended)	EU MDR 2017/745, Article 11
Required when	Manufacturer not established in the UK	Manufacturer not established in the EU
Establishment	Must be established in the UK	Must be established in an EU member state
Named on label	Yes (name and address on UK labeling)	Yes (name and address on EU labeling)
Registration obligation	Must register with MHRA	Must be listed in EUDAMED
Liability exposure	Subject to UK regulatory enforcement	Subject to EU member state enforcement

Important: The same organization can serve as both UKRP and EU Authorized Representative if it has legal entities established in both the UK and the EU. Many regulatory service providers now offer combined UKRP and EU AR services. However, the two roles are legally distinct, and the obligations under each regime differ.

Northern Ireland: The CE + UKNI Marking

The Windsor Framework

Northern Ireland occupies a unique position in post-Brexit medical device regulation. Under the Windsor Framework (which replaced the original Northern Ireland Protocol), Northern Ireland remains aligned with EU single market rules for goods, including medical devices.

This means:

• EU MDR and IVDR apply in Northern Ireland. Devices placed on the Northern Ireland market must comply with the EU MDR (for medical devices) or IVDR (for IVDs), not the UK MDR 2002.
• CE marking is required in Northern Ireland for devices that fall under the EU regulations.
• EU Notified Bodies can certify devices for the Northern Ireland market.
• UK Approved Bodies can also certify devices for the Northern Ireland market — but in this case, the device must carry the CE + UKNI composite marking, not the CE mark alone.

The CE + UKNI Marking

The UKNI marking is used in combination with the CE marking when a UK Approved Body has been used for conformity assessment of a device intended for the Northern Ireland market. The rules are:

Marking	When Used	Market Access
CE only (via EU Notified Body)	Device assessed by an EU Notified Body under EU MDR/IVDR	Northern Ireland + EU + Great Britain (under CE recognition)
CE + UKNI (via UK Approved Body)	Device assessed by a UK Approved Body under EU MDR/IVDR (as applicable in NI)	Northern Ireland + Great Britain only — NOT valid for the EU market
UKCA only	Device assessed under UK MDR 2002	Great Britain only — NOT valid for Northern Ireland or EU

Practical Implications

The Northern Ireland rules create a strategic consideration for manufacturers:

• If you want to access both the EU and UK markets with a single conformity assessment, use an EU Notified Body. The CE marking gives you access to the EU, Northern Ireland, and Great Britain (under the indefinite CE recognition policy).
• If you use a UK Approved Body for Northern Ireland, the CE + UKNI marking gives you access to Northern Ireland and Great Britain — but not the EU. You would need a separate EU Notified Body certificate to access the EU market.
• Devices with UKCA marking only cannot be placed on the Northern Ireland market.

For most manufacturers, the pragmatic approach is to maintain CE marking through an EU Notified Body, which provides the broadest market access.

Windsor Framework: Deeper Implications

The Windsor Framework (which replaced the original Northern Ireland Protocol from 1 January 2025) has several additional implications for medical device manufacturers:

Drug-Device Combination Products: The Windsor Framework creates particular complexity for drug-device combination products. With UK-wide Marketing Authorisations now standard practice, combination products must simultaneously satisfy both UK MDR 2002 requirements (for Great Britain) and EU MDR requirements (for Northern Ireland). In practice, this means the more stringent EU requirements take precedence, and manufacturers seeking UK-wide Marketing Authorisation must comply with Northern Ireland's requirements and obtain an EU Notified Body Opinion. This effectively eliminates GB-only pathways for drug-device combination products.

MHRA's Northern Ireland Engagement: In November 2025, the MHRA held its first Board seminar in Belfast and announced a strengthened programme of collaboration with the Department of Health in Northern Ireland. Key commitments include:

• Expanding the visibility and use of the Yellow Card scheme across Northern Ireland to improve surveillance of medicines and medical devices
• Increasing participation in cutting-edge research to accelerate development of new therapies
• Establishing an MHRA presence in Northern Ireland to support closer engagement with local industry, academia, and the health and care system

Registration Changes for Northern Ireland: From 28 May 2026, new registration requirements take effect for medical devices placed on the Northern Ireland market. Manufacturers should check the MHRA's DORS guidance for Northern Ireland-specific registration obligations and fees.

International Reliance and Northern Ireland: Under the proposed International Recognition Framework, if an IR (International Recognition) certificate is issued based on an EU CE certification, the device could also be placed on the Northern Ireland market — providing a streamlined route for internationally approved devices to access the entire UK.

Device Classification in the UK

Current Classification Rules

Under the UK MDR 2002, medical devices are classified using rules that are essentially identical to the MDD classification rules. The four classes are:

Class	Risk Level	Examples	Third-Party Assessment Required?
Class I	Lowest	Stethoscopes, tongue depressors, non-sterile wound dressings, reusable surgical instruments	No (self-declaration) — except for sterile, measuring, or reusable surgical instrument subclasses
Class I sterile / measuring / reusable surgical	Low with specific concerns	Sterile gloves, clinical thermometers, reusable laparoscopic instruments	UK Approved Body for sterile/measuring/reprocessing aspects only
Class IIa	Medium	Powered surgical instruments, hearing aids, short-term surgically invasive devices, diagnostic ultrasound	Yes — UK Approved Body or EU Notified Body
Class IIb	Medium-high	Ventilators, dialysis machines, non-absorbable sutures, radiotherapy devices	Yes — UK Approved Body or EU Notified Body
Class III	Highest	Total hip replacements, coronary stents, pacemakers, breast implants, drug-eluting devices	Yes — UK Approved Body or EU Notified Body

IVD Classification

IVDs under the current UK framework follow the IVDD classification approach (list-based), not the IVDR risk-based classification:

Category	Description	Examples
List A (Annex II, List A)	Highest risk — reagents for detecting/confirming specific infections and blood grouping	HIV, Hepatitis B/C screening, blood grouping reagents
List B (Annex II, List B)	High risk — specific diagnostic areas	PSA testing, rubella/toxoplasmosis antibodies, HbA1c, blood glucose self-testing
Self-testing	IVDs intended for use by lay persons	Pregnancy tests, ovulation tests, cholesterol self-testing
General IVDs	All other IVDs not in the above categories	General clinical chemistry reagents, hematology reagents, culture media

Future Classification: Planned Changes

The MHRA has indicated that the planned new UK regulatory framework will adopt a risk-based classification system for IVDs similar to the IVDR's four-class system (A, B, C, D). For general medical devices, the classification rules are expected to remain broadly aligned with the current four-class system but may incorporate updates — particularly for software and AI-based devices.

Registration with the MHRA

Who Must Register

All medical devices placed on the Great Britain market must be registered with the MHRA. This applies to:

• All device types (general medical devices, active implantable devices, IVDs, custom-made devices)
• All risk classes
• Both CE-marked and UKCA-marked devices
• Both UK-manufactured and imported devices

Registration Process: The Device Online Registration System (DORS)

Registration is done through the MHRA's Device Online Registration System (DORS), the dedicated online portal for all medical device registration in Great Britain. DORS is the system through which manufacturers, UK Responsible Persons, and Northern Ireland Authorised Representatives manage their device registrations, pay fees, and maintain compliance records.

The DORS registration process requires:

1. Account creation — The manufacturer or UKRP creates an account on DORS. For non-UK manufacturers, the UKRP typically manages the DORS account on behalf of the manufacturer.
2. Manufacturer information — Company name, address, contact details, UKRP details (if applicable). It is critical to keep these details up-to-date; from April 2026, updates to organisation details will no longer incur a fee.
3. Device information — For each device or device family: device name, type, classification, intended purpose, Global Medical Device Nomenclature (GMDN) code, whether it contains a medicinal substance or is manufactured using tissues of animal origin. Each device is mapped to a GMDN Level 2 Category, which is the basis for the new annual fee structure from April 2026.
4. Certificate information — Details of the relevant conformity assessment certificate (CE or UKCA), including the Notified Body or Approved Body number
5. Payment — Registration fees (see fees section below)

Important DORS operational notes:

• The MHRA has implemented a Public Access Registration Database (PARD), where medical device brand/trade names are publicly displayed from 23 February 2026
• Draft (TEMP) applications in DORS that have not been finalised will be deleted during system transitions — manufacturers should finalise or delete drafts before fee changeover dates
• DORS will be offline from 5:00 pm on 30 March 2026 for essential updates related to the new fee structure, going live on 1 April 2026
• Account statuses of "Suspended" require immediate action; suspended accounts will be closed on 1 April 2026 and cannot place devices on the UK market or request Certificates of Free Sale
• UKRPs and Northern Ireland Authorised Representatives are responsible for collecting fees from their represented manufacturers and submitting payments via DORS

Registration Timelines

The MHRA has implemented registration in phases, with deadlines varying by device risk class:

Device Category	Registration Deadline
Class III and Class IIb implantable medical devices	Already required
Class IIa and Class IIb non-implantable medical devices	Already required
Class I medical devices	Already required
IVDs — List A and self-testing	Already required
IVDs — List B	Already required
General IVDs	Already required

As of 2026, all device categories are required to be registered. The MHRA has indicated that registration will be an ongoing obligation — not a one-time event — and that registered information must be kept up to date.

What Registration Is Not

MHRA registration is not a market authorization or marketing approval. It does not constitute a review of the device's technical documentation, clinical evidence, or compliance with essential requirements. It is an administrative registration that provides the MHRA with visibility into the devices on the UK market and enables post-market surveillance.

However, placing an unregistered device on the Great Britain market is a regulatory offence. The MHRA has enforcement powers and has signaled its intention to take action against non-compliant economic operators.

Clinical Investigation Requirements

Regulatory Basis

Clinical investigations of medical devices conducted in the United Kingdom require notification to and authorization by the MHRA. The legal basis is the UK MDR 2002, supplemented by MHRA guidance.

When a Clinical Investigation Is Required

A clinical investigation may be required when:

• The manufacturer needs to generate clinical data to support the clinical evaluation for conformity assessment
• The device is novel and there is insufficient existing clinical data
• The device involves a new intended purpose, a new patient population, or a significant change to a previously assessed device
• Post-market clinical follow-up (PMCF) requires prospective data collection

The Approval Process

Step	Description	Typical Timeline
1. Ethics Committee approval	All clinical investigations involving human subjects require approval from a Research Ethics Committee (REC) recognized by the Health Research Authority (HRA)	4–8 weeks
2. MHRA notification	The sponsor must notify the MHRA of the clinical investigation at least 60 days before commencement (for Class III and implantable devices) or at least 60 days for other devices where the MHRA requires review	60 days statutory review period
3. HRA approval	For studies conducted in NHS settings in England, HRA approval is required in addition to REC approval	Typically parallel with REC
4. Site-specific considerations	Local R&D approval or capacity and capability assessment at each participating site	Variable

Key Requirements for Sponsors

• Clinical investigation plan (CIP): A detailed protocol meeting the requirements of EN ISO 14155 (Clinical investigation of medical devices for human subjects — Good clinical practice)
• Investigator's brochure: Comprehensive information on the device for investigators
• Informed consent: Compliant with UK-specific consent requirements and the UK General Data Protection Regulation (UK GDPR)
• Insurance and indemnity: Adequate insurance coverage for clinical investigation participants
• Adverse event reporting: Serious adverse events and device deficiencies must be reported to the MHRA within defined timeframes
• Annual safety reports: Periodic reporting to the MHRA on the safety of the investigation

International Multisite Studies

For clinical investigations conducted in both the UK and EU, sponsors must submit separate applications to the MHRA and the relevant EU member state Competent Authorities. The UK is not part of the EU's Clinical Investigation Assessment system under the EU MDR. This means dual submissions, potentially different review timelines, and the need to track UK-specific and EU-specific requirements independently.

Practical tip: The MHRA has been receptive to pre-submission meetings for clinical investigations, particularly for novel devices. Engaging the MHRA early can help clarify device classification, clinical investigation design, and data requirements before formal submission.

Post-Market Surveillance: The June 2025 Overhaul

Landmark PMS Reform: 16 June 2025

On 16 June 2025, the first major overhaul of UK medical device regulation came into force with the implementation of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368). This legislation, which was made law on 16 December 2024 after a six-month implementation period, represents the most significant update to UK medical device regulation since Brexit.

The new PMS regulations apply to all UKCA- and CE-marked devices placed on the GB market from 16 June 2025 onwards, including in vitro diagnostic devices, active implantable medical devices, and Software as a Medical Device. Devices already on the market before this date remain subject to prior PMS requirements, but the MHRA recommends that manufacturers migrate to the new standard for simplicity, as the new requirements generally exceed the old ones.

Manufacturer Obligations Under the New PMS Framework

Manufacturers must now:

• Establish a formal PMS system — Defined by a documented PMS plan that specifies objectives, data sources (including public and patient feedback), and update frequency, proportionate to the device risk class
• Actively collect and analyze real-world performance data — Proactive monitoring of device safety and performance throughout the product lifecycle, not just reactive incident collection
• Produce periodic reports — Either a Post-Market Surveillance Report (PMSR) or Periodic Safety Update Report (PSUR) depending on device risk class
• Report serious incidents to the MHRA with shortened timelines (see below)
• Report field safety corrective actions (FSCAs) to the MHRA, including Field Safety Notices
• Report trends in incidents, including those that individually may not meet individual reporting criteria but in aggregate indicate a systematic problem
• Maintain records for 15 years for implantable devices and 10 years for other devices, or for the entire PMS period, whichever is longer

PMSR and PSUR Requirements

The new framework introduces structured periodic reporting, differentiated by risk class:

Device Class	Report Type	Update Frequency
Class I medical devices	PMSR (Post-Market Surveillance Report)	First report within defined period; update at least every 3 years
Class IIa medical devices	PSUR (Periodic Safety Update Report)	Update at least every 2 years
Class IIb, Class III, active implantable medical devices	PSUR	Update at least annually
IVDs not on List A/B (general IVDs, Class A/B equivalent)	PMSR	Update at least every 3 years
IVDs on Annex II List A and List B (Class C/D equivalent)	PSUR	Update at least annually

Key PSUR/PMSR requirements:

• The PSUR must follow the MHRA standardised format published in June 2025
• PSURs must include data on devices sold and used both in the UK and internationally, including the size of the population using the device
• The MHRA or UK Approved Body may request PMSR or PSUR at any time, and manufacturers must provide the document within 3 working days
• UK Approved Bodies must review PSURs for any impact on device certification

Practical tip for EU MDR-compliant manufacturers: To avoid duplication, manufacturers may leverage PSUR reports already prepared for EU compliance, provided they specifically address GB-specific requirements within the report. However, the UK and EU PSUR requirements are not identical — ensure your report covers UK-specific data fields.

Updated Incident Reporting Timelines

The June 2025 regulations introduced significantly shortened incident reporting timelines:

Event Type	New Reporting Timeline (from June 2025)	Previous Timeline
Serious public health threat	Immediately, and no later than 2 calendar days	2 calendar days (unchanged)
Death or unanticipated serious deterioration	As soon as possible, and no later than 10 calendar days	10 calendar days (unchanged)
All other serious incidents	As soon as possible, and no later than 15 calendar days	30 calendar days
Field safety corrective actions	Before or in parallel with implementation	Before or in parallel (unchanged)
Trend reports	As identified, with detailed initial and final reports	As identified

The reduction from 30 days to 15 days for reporting other serious incidents is one of the most impactful changes. The scope of reportable incidents has also been broadened — manufacturers must now consider situations where the device malfunctions or deteriorates in characteristics or performance, irrespective of the potential to lead to direct patient harm.

Reporting via the MORE Portal

All incident reports, trend reports, and FSCA reports must be submitted electronically through the MHRA's Manufacturer's Online Reporting Environment (MORE) portal. The MHRA will not accept reports received via other routes.

From 16 October 2025, all manufacturers must use the new Great Britain data schemas when submitting Manufacturer Incident Reports (MIRs) and FSCA reports. Key changes to the reporting schemas include:

• Introduction of UK-specific fields for UK Approved Bodies and UK Responsible Persons
• Restriction of nomenclature to GMDN only
• Requirement to provide IMDRF Annex codes and more detailed UDI information
• Manufacturers with API-integrated systems must update their XSDs

How UK PMS Compares to EU MDR PMS

Manufacturers who already maintain PMS systems compliant with the EU MDR will find the UK's new requirements broadly familiar but not identical. Key differences to note:

Requirement	UK (from June 2025)	EU MDR
Serious incident reporting deadline	15 calendar days (other serious incidents)	15 calendar days (aligned)
PSUR frequency (Class IIa)	Every 2 years	At least every 2 years (aligned)
PSUR frequency (Class IIb/III)	At least annually	At least annually (aligned)
PSUR submission	To UK Approved Body; available to MHRA within 3 working days	To EU Notified Body
SSCP (Summary of Safety and Clinical Performance)	Not currently required	Mandatory for Class III and implantable devices
PMCF	Expected as part of clinical evaluation	Mandatory with detailed PMCF plan and evaluation report
Record retention	15 years (implantable) / 10 years (other)	10 years minimum (15 for implantable under MDR)
Trend reporting	GB-specific requirements with detailed initial and final reports and stricter follow-up timelines	Emphasises coordination across the EU

Important: The new UK PMS framework brings Great Britain significantly closer to alignment with EU MDR PMS requirements. This is a deliberate design choice by the MHRA — making it more practical for manufacturers to operate a single PMS system that covers both markets, with jurisdiction-specific overlays.

Software and AI/ML Medical Device Regulation

MHRA's Software and AI Program

The regulation of Software as a Medical Device (SaMD) and artificial intelligence/machine learning (AI/ML)-enabled devices is one of the areas where the MHRA has been most active and most ambitious in diverging from the EU framework.

The MHRA has positioned the UK as a global leader in adaptive AI/ML regulation, publishing a series of guidance documents and consultation outcomes:

• Software and AI as a Medical Device Change Programme (2021): The MHRA's initial roadmap for regulating software and AI-based medical devices
• Guidance on "Good Machine Learning Practice for Medical Device Development" (GMLP): Developed in collaboration with the FDA and Health Canada — a set of 10 guiding principles for AI/ML-enabled medical devices
• MHRA AI Airlock Regulatory Sandbox (2023-ongoing): A sandbox program allowing developers of AI-enabled medical devices to engage with the MHRA in a structured, iterative review process before formal regulatory submission
• Software and AI as a Medical Device Guidance (2024-2025): Updated guidance on classification, clinical evidence, and lifecycle management for SaMD

Software Classification in the UK

Under the current UK MDR 2002, software classification follows the MDD rules as adapted by MHRA guidance. However, the MHRA has signaled that future software classification will incorporate elements of the IMDRF SaMD risk categorization framework and may differ from both the current MDD rules and the EU MDR's Rule 11.

Key MHRA positions on software classification:

• Software that provides clinical decision support is generally considered a medical device if it is intended to process or analyze patient-specific data for a medical purpose
• Software that performs a diagnostic or therapeutic function is classified based on the risk associated with incorrect output
• General wellness applications and administrative healthcare software are generally not medical devices
• Cybersecurity is considered a component of device safety, and the MHRA expects manufacturers to address cybersecurity throughout the device lifecycle

AI/ML-Specific Considerations

The MHRA has addressed several AI/ML-specific regulatory challenges:

Challenge	MHRA Position
Adaptive algorithms — AI/ML models that learn and change after deployment	The MHRA's AI Airlock program explores regulatory pathways for continuously learning algorithms. The MHRA has indicated openness to a Predetermined Change Control Plan (PCCP) approach, similar to the FDA's concept.
Algorithmic transparency	Manufacturers must be able to explain how the AI/ML model reaches its outputs. The MHRA expects transparency in training data, model architecture, performance metrics, and known limitations.
Bias and equity	Training data must be representative. The MHRA has emphasized that AI/ML devices must demonstrate acceptable performance across relevant demographic subgroups (age, sex, ethnicity) and that training data bias must be documented and mitigated.
Real-world performance monitoring	Post-market surveillance for AI/ML devices must include monitoring of real-world performance, including model drift (degradation in accuracy over time as real-world data distributions change).

The AI Airlock Sandbox

The MHRA's AI Airlock is a regulatory sandbox designed specifically for AI-enabled medical devices — the first of its kind globally. It allows manufacturers to:

• Engage with MHRA regulators in a structured dialogue during product development
• Receive guidance on classification, clinical evidence requirements, and post-market surveillance obligations for AI/ML devices
• Test regulatory approaches for adaptive algorithms in a controlled environment
• Gather evidence that can support formal regulatory submissions

The AI Airlock is not a fast-track approval pathway — devices still need to go through standard regulatory processes. But it provides a structured mechanism for manufacturers of novel AI/ML devices to reduce regulatory uncertainty before investing in full-scale development and clinical validation.

AI Airlock Pilot Phase (Spring 2024 - April 2025)

The pilot programme launched in Spring 2024 with a small number of initial products, across a range of clinical disciplines and at varying levels of regulatory maturity. One of the four inaugural projects was Philips Radiology Auto Impression, which tested generative AI to draft radiologist conclusion sentences, with weekly design reviews with MHRA scientists. The pilot closed in April 2025, and the MHRA published comprehensive reports on the regulatory sandbox methodology, results from the case studies, and an independent programme evaluation. Key findings have been channeled into the MHRA's Software and AI as a Medical Device Change Programme and the National Commission into the Regulation of AI in Healthcare.

AI Airlock Phase 2 (October 2025 - March 2026)

In March 2025, the UK government confirmed in its Regulatory Action Plan that the AI Airlock would run a second phase during the 2025-2026 financial year. Applications opened on 23 June 2025 and closed on 14 July 2025. On 16 October 2025, the MHRA announced the selection of seven additional AI-enabled technologies for Phase 2, spanning:

• AI-powered clinical note taking
• Advanced cancer diagnostics
• Eye disease detection tools
• Obesity treatment support systems

Phase 2 focuses on three fundamental regulatory challenges:

1. Managing evolving AI applications — How to regulate adaptive/self-learning AI-enabled devices that change after deployment
2. Regulating AI-powered diagnostics effectively — Classification, evidence, and validation requirements for AI diagnostics
3. Implementing robust post-market surveillance — How manufacturers monitor performance and detect model drift in deployed AI

The AI Airlock uses three testing environments, including both multi-environment and simulation candidates. Phase 2 will run until March 2026.

National Commission into the Regulation of AI in Healthcare

Launched on 26 September 2025, the National Commission into the Regulation of AI in Healthcare is a major new initiative bringing together global AI leaders, clinicians, and regulators to advise the MHRA on the development of a new regulatory framework for AI in healthcare. The Commission's recommendations will be published by the MHRA in 2026.

Key details:

• Chair: Professor Alastair Denniston, head of the UK's Centre of Excellence in Regulatory Science in AI and Digital Health (CERSI-AI)
• Deputy Chair: Patient Safety Commissioner Professor Henrietta Hughes
• Membership: Includes health professionals, regulators, AI specialists, and experts from organizations including Google and Microsoft
• Research partner: The Health Foundation
• Four working groups cover key regulatory topics, with monthly meetings during the recommendation development phase

The Commission ran a Call for Evidence from 18 December 2025 to 2 February 2026, open to the public, patients, clinicians, industry, and international stakeholders. Its work is explicitly linked to the government's 10-Year Health Plan for England and the Life Sciences Sector Plan, which commit to the NHS becoming the most AI-enabled healthcare system in the world.

The Commission is expected to publish recommendations in 2026 that will inform:

• A new regulatory framework specifically for AI in healthcare
• Updated MHRA guidance on SaMD and AI as a Medical Device
• How to manage the overlap between multiple sources of assurance (regulation of medical devices, oversight of healthcare professionals, regulation of health services)
• How liability and responsibility are distributed across the AI supply chain

MHRA-FDA Collaboration on AI

In October 2025, the MHRA announced a formal collaboration with the U.S. FDA to align regulatory processes for medical devices, with particular focus on AI. The partnership aims to:

• Reduce regulatory duplication between the two agencies
• Accelerate patient access to safe, innovative technologies
• Develop shared standards for evaluating AI-based devices

This collaboration would allow medical devices cleared under FDA frameworks (510(k), De Novo, PMA) to more easily gain UK regulatory approval under the planned International Recognition Framework, with reliance routes expected to become operational from 2027.

UK-Singapore Regulatory Innovation Corridor

The MHRA has also launched a Regulatory Innovation Corridor with Singapore's Health Sciences Authority (HSA), creating a fast-track pathway for breakthrough health technologies to move between the two markets. This builds on the MHRA's broader strategy of international partnerships to reduce regulatory barriers for innovative devices.

Strategic note for AI/ML developers: The UK's approach to AI/ML medical device regulation is arguably the most progressive globally. The combination of the AI Airlock sandbox, the National Commission, formal MHRA-FDA collaboration, and the planned International Recognition Framework makes the UK an increasingly attractive first or early market for AI/ML device developers. The MHRA has signaled that it will deliver regulatory reform for SaMD through light-touch regulatory amendment and updated guidance, more streamlined processes, and potential up-classification of SaMD from the current Class I. This area remains in flux — manufacturers should monitor the National Commission's 2026 recommendations closely.

IVD Regulation in the UK

Current IVD Framework

In vitro diagnostic medical devices (IVDs) in Great Britain are currently regulated under Part IV of the UK MDR 2002, which is based on the old EU IVDD (98/79/EC). This means the UK is still operating under the list-based classification system (Annex II List A, List B, self-testing, general IVDs), not the IVDR's risk-based classification (Classes A, B, C, D).

Planned Changes for IVDs

The MHRA has consulted on a new IVD regulatory framework that would:

• Introduce risk-based classification similar to the IVDR (four classes based on risk, replacing the list-based system)
• Require Approved Body involvement for a significantly larger proportion of IVDs (mirroring the IVDR's shift from approximately 20% to approximately 80% of IVDs requiring third-party assessment)
• Strengthen performance evaluation requirements — requiring documented evidence of scientific validity, analytical performance, and clinical performance
• Introduce companion diagnostic-specific requirements — including requirements for coordination with the relevant medicinal product manufacturer and the MHRA's medicines licensing division
• Address novel IVD technologies — including next-generation sequencing, liquid biopsy, and AI-based diagnostic algorithms

IVD Registration

All IVDs placed on the Great Britain market must be registered with the MHRA. The registration process is similar to that for general medical devices, but with IVD-specific data fields including:

• Common name and type of IVD
• Analyte(s) detected
• Whether the IVD is for self-testing
• Whether the IVD is a companion diagnostic
• Annex II classification (List A, List B, or general)

The MHRA IVD Roadmap (December 2025)

On 15 December 2025, the MHRA published its first dedicated In Vitro Diagnostic (IVD) Medical Device Roadmap (Version 1.0), a "living" strategic document outlining planned priorities and deliverables for the IVD regulatory programme through mid-2027. This roadmap complements the broader Medical Devices Regulatory Reform Roadmap and provides important clarity on the MHRA's IVD-specific direction.

The roadmap is structured around three themes:

Theme 1: Regulatory Support for Innovative IVD Technologies

• Establish an integrated application pathway for performance studies of companion diagnostics (CDx) and clinical trials for medicines (2026-2027)
• Publish best practice guidance for innovative IVDs on genetic testing, pharmacogenomics, and Software as an IVD (SaIVD) (2026)
• Publish best practice guidance on a risk-based approach to clinical evidence requirements for different CDx (2026-2027)
• Establish links with institutions supporting research in novel biomarkers for dementia and cancer genomics, and novel IVDs for antimicrobial resistance (AMR)

Theme 2: Regulatory Science and Research

• Expand portfolio of biological standards and reference materials, including in silico standards, based on emerging trends in IVDs (2026-2027)
• Embed collaborations with national and international organisations for rapid development and dissemination of reference materials

Theme 3: Pandemic Preparedness and Resilience

• Adopt the IMDRF clinical evidence framework for IVDs targeting pandemic pathogens
• Publish a statement addressing gaps identified by the International Pandemic Preparedness Secretariat (IPPS) for diagnostic regulation

IVD-Specific Legislative Developments

The July 2025 consultation response confirmed several important IVD-specific changes:

• Alignment with EU common specifications for high-risk IVDs — In July 2025, the government announced it would align with European specifications on high-risk in vitro diagnostic devices to reduce regulatory burden
• Updated IVD classification rules will be introduced as part of the upcoming pre-market Statutory Instrument in 2026, moving toward risk-based classification
• IVD performance studies in Northern Ireland — A new application process for IVD performance studies in Northern Ireland was launched during 2024-2025
• CE-marked IVDs will continue to have a pathway to the GB market at least until 2030, and potentially indefinitely if the current CE recognition consultation proceeds as expected

Timeline for IVD Transition

While the full new IVD framework has not yet been legislated, the direction is clear:

Timeline	IVD Development
Current	List-based classification (IVDD) applies in GB
2026	Pre-market SI expected to introduce updated IVD classification rules; IVD Roadmap deliverables begin
2026-2027	Guidance for innovative IVDs (genetic testing, SaIVD, CDx) published
2027+	Full risk-based classification system (A, B, C, D) expected to be implemented with transition periods

IVD manufacturers should monitor the MHRA's IVD Roadmap updates and begin preparing for the transition to risk-based classification, which will significantly increase the proportion of IVDs requiring third-party assessment by a UK Approved Body.

Fees and Timelines

MHRA Device Registration Fees: Major Change from April 2026

The MHRA is implementing a fundamental change to its fee structure for medical device registration, transitioning from a one-off registration fee to an annual charge. This represents a shift to a lifecycle-based compliance model aligned with ongoing post-market surveillance funding.

Current Fee Structure (Until 31 March 2026)

Fee Type	Amount
One-off device registration fee (per application in DORS)	£261 (increased from £240 in July 2025)
UK Responsible Person registration	Included with device registration
Clinical investigation application (Class III / implantable)	£4,000 - £8,000
Clinical investigation application (other devices)	£2,000 - £4,000
Regulatory advice meeting	See MHRA current fees page (new fee section added July 2025)
Variations and amendments	Variable

New Annual Fee Structure (From 1 April 2026)

On 2 September 2025, the MHRA published its updated consultation response confirming a new annual fee model. This replaces the current one-off registration fee and funds the MHRA's post-market surveillance activities — which were previously funded by government grants from the Department of Health and Social Care, a model inconsistent with HM Treasury's "Managing Public Money" guidance requiring full cost recovery.

Aspect	Details
Fee basis	Per GMDN Level 2 Category (not per individual device or product)
Estimated annual fee	~£300 per GMDN Level 2 Category per year
Frequency	Annual, charged for the financial year 1 April to 31 March
First charging year	2026/27 (from 1 April 2026)
Payment deadline	Within 90 days of 1 April each year
Payment methods	BACS, CHAPS, or Worldpay card payment — all via DORS
Who pays	All manufacturers with devices registered in Great Britain, regardless of location
For non-UK manufacturers	UKRP collects fees from represented manufacturers and submits via DORS

How GMDN Level 2 Categories work:

The fee is charged per GMDN Level 2 Category (the "Device Group" level), not per individual GMDN term or device model. For context, the GMDN hierarchy works as follows:

• Level 1 (Device Category): e.g., Active Device
• Level 2 (Device Group): e.g., Cardiovascular Device
• Level 3 (Subgroup): e.g., Cardiac Rhythm Management Device
• Level 4 (Device Type): e.g., Implantable Pulse Generators
• Level 5 (Preferred Term): e.g., Pacemaker, cardiac, implantable

If multiple devices are registered under the same Level 2 Category, only one annual fee applies. Where a device falls under more than one Level 2 Category, the fee is charged once per category. Where no Level 2 exists, the Level 1 Category fee applies.

The MHRA expects approximately 60% of manufacturers to pay a single annual charge (i.e., all their devices fall under one GMDN Level 2 Category). DORS will automatically calculate the lowest possible fee for each manufacturer.

Impact of non-payment:

• Failure to pay within 90 days results in account suspension
• Suspended accounts cannot place devices on the UK market or request Certificates of Free Sale
• Accounts in "Suspended" status on 1 April 2026 will be closed

Critical action required by 30 March 2026: All manufacturers and UKRPs should review their DORS registrations, unregister any obsolete or withdrawn devices, ensure all data is correct (particularly GMDN codes), and finalize or delete any draft applications. DORS will be offline from 5:00 pm on 30 March 2026 for the transition. The MHRA began emailing fee estimates to manufacturers from November 2025, with final fees visible in DORS from 1 April 2026.

Fee Waivers and Small Company Easements

The MHRA has updated its guidance on payment easements and waivers for small and medium enterprises. Manufacturers should check the MHRA's current fees page for details on eligibility and the application process.

Approved Body Fees (Separate)

Note: These are MHRA registration fees only. Approved Body fees for conformity assessment are separate and vary by Approved Body, device complexity, and scope of assessment. Approved Body fees for a full UKCA conformity assessment can range from tens of thousands to hundreds of thousands of pounds, depending on the device risk class and the scope of the assessment.

Typical Timelines

Process	Typical Duration
MHRA device registration	2–4 weeks (straightforward applications)
UK Approved Body conformity assessment (initial)	6–18 months (depending on device class and AB capacity)
Clinical investigation authorization	60 days statutory review period (may be extended with questions)
Ethics Committee review	4–8 weeks
MHRA pre-submission meeting	4–8 weeks to schedule; meeting itself typically 1–2 hours

Recent Regulatory Developments (2024-2026)

MHRA Consultations and Policy Updates

The period from 2024 to early 2026 has been one of the most active periods for UK medical device regulatory policy since Brexit. Key developments include:

2024 Developments:

• Indefinite CE marking recognition consultation (2024): The MHRA consulted on and subsequently confirmed the policy of indefinite recognition of CE marking for the Great Britain market, abandoning the previous approach of setting hard deadlines for UKCA transition. This was the most significant policy shift since Brexit, acknowledging the practical impossibility of requiring tens of thousands of devices to be recertified under the UK system within a fixed timeframe.
• New UK regulatory framework consultation (2024): The MHRA published its consultation on a comprehensive new regulatory framework for medical devices and IVDs in the UK. The consultation covered device scope, classification, essential requirements (renamed "General Safety and Performance Requirements" in line with international terminology), conformity assessment, post-market surveillance, clinical evidence, UDI, and economic operator obligations.
• International Recognition Framework (IRF) proposal (2024): One of the most distinctive proposals in the MHRA's consultation was the International Recognition Framework — a pathway that would allow the MHRA to recognize regulatory decisions by trusted international regulators (such as the FDA, Health Canada, TGA Australia, and potentially EU Notified Bodies) as the basis for UK market access. This "reliance" pathway would reduce duplicative regulatory review and could significantly speed market access for devices already approved in recognized jurisdictions.
• Software and AI guidance updates (2024): Continued expansion of the MHRA's software and AI regulatory program, including updated guidance on software classification, AI/ML transparency requirements, and real-world performance monitoring.

2025 Developments:

• Post-Market Surveillance regulations come into force (16 June 2025): The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered force, representing the first major overhaul of UK medical device regulation since Brexit. The regulations introduced mandatory PMS plans, PMSR/PSUR requirements, shortened incident reporting timelines (15 days vs. 30 days), and new digital reporting through the MORE portal.
• Consultation response on routes to market (26 February 2025 and 22 July 2025): The government published its response to the November 2024 consultation in two parts. The February response covered assimilated EU law, while the July response addressed international reliance, UKCA marking, and IVD devices. Key outcomes: indefinite CE recognition to be consulted on, international reliance routes to proceed, UKCA repositioned for first-in-market innovations, simplified Class I requirements, and alignment of Essential Requirements with EU MDR GSPRs.
• Registration fee increase (16 July 2025): The one-off DORS registration fee increased from £240 to £261 per application.
• New MHRA leadership: Lawrence Tallon joined the MHRA as Chief Executive in April 2025, championing a regulatory approach focused on patient safety, improved access, innovation, and international partnerships.
• AI Airlock Phase 2 (October 2025 - March 2026): Seven additional AI technologies selected for the second phase, focusing on adaptive algorithms, AI diagnostics, and PMS for AI devices.
• National Commission into the Regulation of AI in Healthcare (26 September 2025): Launched to advise the MHRA on a new regulatory framework for AI in healthcare, to be published in 2026. Call for Evidence ran from December 2025 to February 2026.
• MHRA-FDA collaboration announced (October 2025): Formal partnership to align regulatory processes for medical devices, with particular focus on AI. Reliance routes (including FDA recognition) expected to become operational from 2027.
• UK-Singapore Regulatory Innovation Corridor: Launched to create a fast-track pathway for breakthrough health technologies between the two markets.
• IVD Roadmap published (15 December 2025): First dedicated IVD regulatory roadmap outlining priorities through mid-2027, covering innovative IVD technologies, regulatory science, and pandemic preparedness.
• Updated clinical investigation guidance (October 2025): MHRA published Version 11.1 of its Guidance for Manufacturers on Clinical Investigations of Medical Devices, aligned with the UK Medical Devices Regulations 2025.
• MHRA-Northern Ireland strengthened collaboration (November 2025): First MHRA Board seminar in Belfast; commitments to expand Yellow Card scheme, increase research participation, and establish MHRA presence in Northern Ireland.
• Electronic labeling guidance: MHRA confirmed CE-marked devices are accepted with electronic IFUs as long as they comply with relevant EU regulations.
• TUV SUD BABT IVD designation: Expanded scope to include IVD medical devices (designation until 2 July 2030).
• Annual PMS fee model confirmed (September 2025): Updated consultation response confirmed ~£300 per GMDN Level 2 Category annual fee from April 2026.
• MHRA designated as WHO-Listed Authority: For medicines and vaccines, strengthening the UK's international regulatory standing.
• Approved Body capacity expansion: New designations for DEKRA (active implantable medical devices), Eurofins E&E CML, Scarlet NB UK, and UL International (UK).

2026 Developments (to date):

• Consultation on indefinite CE recognition (16 February 2026 - 10 April 2026): Formal MHRA consultation seeking views on indefinite recognition of EU MDR/IVDR CE-marked devices, extending MDD transitional timelines to align with EU, and introducing international reliance routes for higher-risk reclassified devices.
• Pre-market Statutory Instrument in development: The government is drafting the pre-market SI to introduce new requirements before devices can be placed on the market, including the international reliance scheme, updated classification rules, UDI requirements, alignment of Essential Requirements with GSPRs, and strengthened technical documentation requirements. Expected to come into force in 2026, subject to WTO notification and Parliamentary scheduling.
• DORS fee transition (1 April 2026): New annual fee model replaces one-off registration fees. First annual ~£300 per GMDN Level 2 Category charges apply for the 2026/27 financial year. DORS offline 30 March for transition.
• Northern Ireland registration changes (28 May 2026): New registration requirements for medical devices placed on the Northern Ireland market take effect.
• Public Access Registration Database (PARD) expansion: Medical device brand/trade names displayed publicly on PARD from 23 February 2026.
• National Commission AI recommendations expected: The Commission's regulatory framework for AI in healthcare is expected to be published in 2026.
• Wider MHRA regulatory proposals due Autumn 2026: Particularly focused on clarity for SaMD and AI as a Medical Device regulation.
• International cooperation advancing: MHRA continues strengthening bilateral cooperation with the FDA, Health Canada, TGA, and HSA Singapore, including mutual information sharing, joint guidance development, and regulatory innovation corridors.

The International Recognition Framework (IRF)

The IRF proposal deserves particular attention because it represents a fundamentally different approach to medical device regulation — one based on regulatory reliance rather than independent reassessment.

Under the proposed IRF, the MHRA would be able to:

• Recognize conformity assessment decisions from specified international regulators as sufficient evidence for UK market access
• Apply this recognition on a pathway-specific basis — for example, recognizing FDA 510(k) clearances for certain device types, or recognizing EU MDR CE certificates
• Maintain the MHRA's authority to impose UK-specific conditions (such as labeling in English and MHRA registration) even for recognized devices
• Retain the power to require additional evidence or reject recognition for specific device categories where the MHRA determines the recognized decision is insufficient

If implemented, the IRF would be a significant advantage for manufacturers already approved in the US, EU, Canada, or Australia — potentially allowing UK market access with minimal additional regulatory burden.

IRF Implementation Timeline

The IRF is being taken forward as part of the pre-market Statutory Instrument currently being developed. The expected timeline is:

Phase	Timing
Testing and industry engagement	2025 (completed)
Legislative framework introduced	2026 (pre-market SI, subject to WTO notification and Parliamentary time)
Reliance routes become operational	2027 (including FDA recognition)

Key clarification: An International Recognition certificate will grant devices access to the GB market, but it will not provide a UKCA marking or UKCA certification. If an IR certificate is issued based on an EU CE certification, the device could also be placed on the Northern Ireland market. Manufacturers must still comply with UK-specific labeling, PMS, and Responsible Person requirements.

Important caveat: While the policy direction is firmly established — with formal MHRA-FDA collaboration announced in October 2025 and strong government backing — the final legislative text and operational details remain to be confirmed. Manufacturers should plan based on current requirements while positioning themselves to take advantage of reliance routes once available.

UK vs. EU MDR: Comparison Table

Understanding how the UK framework compares to the EU MDR is essential for manufacturers operating in both markets. The following table compares the current UK system (UK MDR 2002 as amended), the planned future UK framework, and the EU MDR.

Aspect	UK (Current — UK MDR 2002)	UK (Planned New Framework)	EU MDR 2017/745
Legal basis	UK MDR 2002 (based on MDD/AIMDD/IVDD)	New UK regulations (in development)	Regulation (EU) 2017/745
Regulatory authority	MHRA	MHRA	Competent Authorities of EU member states
Conformity marking	UKCA (or CE under recognition)	To be confirmed	CE
Device classification (medical devices)	4 classes (MDD rules: I, IIa, IIb, III)	4 classes (expected to broadly align with EU MDR rules)	4 classes (22 rules under Annex VIII)
IVD classification	List-based (IVDD: List A, List B, self-testing, general)	Risk-based (expected 4 classes: A, B, C, D)	Risk-based (4 classes: A, B, C, D under IVDR)
Third-party assessment bodies	UK Approved Bodies	UK Approved Bodies	EU Notified Bodies
Responsible Person / AR	UK Responsible Person (UKRP)	UKRP (to be confirmed)	Authorized Representative (Article 11)
UDI	Not yet mandatory (planned)	UDI system planned	Mandatory (phased implementation)
EUDAMED equivalent	MHRA registration database	Enhanced device database planned	EUDAMED (phased rollout)
Clinical evidence	Essential requirements + clinical evaluation per MDD principles	Enhanced clinical evidence requirements expected	Comprehensive clinical evaluation, PMCF, SSCP
Post-market surveillance	Vigilance reporting, less prescriptive PMS plan requirements	Enhanced PMS requirements expected (PSUR, PMCF)	Detailed PMS plan, PSUR, PMCF, SSCP
Person Responsible for Regulatory Compliance	Not currently required	Under consideration	Mandatory PRRC with defined qualifications
Scrutiny procedure	Not applicable	Under consideration	Yes (Article 54 — Class III implants, certain Class IIb)
International Recognition Framework	Not yet available	Proposed — recognition of decisions by trusted regulators	Not applicable (no equivalent)
Software / AI specific rules	MHRA guidance; AI Airlock sandbox	Enhanced software classification; adaptive algorithm pathways	Rule 11 classification; MDCG guidance
Economic operators	Manufacturer, UKRP, importers	Expanded obligations expected	Manufacturer, AR, importer, distributor
Harmonized/Designated standards	UK designated standards (largely based on EN/ISO)	UK designated standards (updated)	Harmonized European standards (hENs)
PMS reporting (serious incidents)	15 calendar days (from June 2025)	Aligned with new PMS regs	15 calendar days
PSUR/PMSR	PMSR for Class I; PSUR for Class IIa+ (from June 2025)	Enhanced requirements in force	PMSR for Class I; PSUR for Class IIa+
Registration system	DORS (Device Online Registration System)	DORS with annual fee model	EUDAMED (phased rollout)
Annual registration fees	~£300/GMDN Level 2 Category (from April 2026)	Ongoing annual model	Varies by member state
International reliance	Not yet available	Proposed — recognition from FDA, TGA, Health Canada	Not applicable
Regulatory sandbox	AI Airlock (operational, Phase 2 running)	Expanded AI Airlock + National AI Commission	BtX Breakthrough Device pathway (from Dec 2025)
Fees	MHRA registration fees (~£300/GMDN Level 2 category annually from April 2026)	Annual fee model in force	Varies by member state; NB fees separate

Practical Guidance for CE-Marked Manufacturers

If your devices are already CE marked and you want to access the Great Britain market, here is a step-by-step approach:

Step 1: Confirm CE Marking Status

Verify that your CE certificate is current and valid. Determine which regulatory framework your CE marking is under:

• MDD/AIMDD/IVDD certificate: Valid for Great Britain under the indefinite CE recognition policy, subject to conditions
• EU MDR/IVDR certificate: Also valid for Great Britain under the CE recognition policy

If your MDD certificate is approaching expiry and you are transitioning to EU MDR, ensure continuity of your CE marking. A gap in CE certification could affect your UK market access.

Step 2: Appoint a UK Responsible Person

If you are not established in the UK, you must appoint a UKRP. Options include:

• Engaging a specialist regulatory services company that offers UKRP services
• Using your existing UK distributor if they are willing and capable of fulfilling UKRP obligations
• Establishing your own UK subsidiary (typically only practical for larger companies)

Ensure your UKRP understands their obligations — particularly around vigilance cooperation, MHRA correspondence, and maintaining access to technical documentation.

Step 3: Register with the MHRA

Register your devices on the MHRA's online registration system. Registration must be completed before devices are placed on the market. You will need:

• Manufacturer details
• UKRP details (name, UK address)
• Device information (name, type, GMDN code, classification)
• CE certificate details

Step 4: Review UK Labeling Requirements

Ensure your device labeling meets UK-specific requirements:

• Language: Labeling and Instructions for Use must be in English
• UKRP details: The name and address of the UKRP must appear on the labeling (or on a document accompanying the device)
• Importer details: If the device is imported into the UK by an importer (distinct from the manufacturer or UKRP), the importer's details should appear on the labeling
• No requirement to add UKCA marking if you are relying on CE marking recognition — but you may not alter or obscure the CE marking

Step 5: Establish UK Vigilance Reporting

Ensure you have processes in place to report incidents, FSCAs, and trends to the MHRA. If you already have an EU vigilance system, you will need to add the MHRA as a reporting destination alongside the relevant EU Competent Authorities. Incident reporting to the MHRA is independent of reporting to EU authorities — you must report to both if an incident involves a device on both markets.

Step 6: Monitor Regulatory Developments

The UK regulatory framework is evolving. Manufacturers should:

• Subscribe to MHRA email updates and alerts
• Monitor the MHRA's gov.uk medical devices page for guidance updates
• Track MHRA consultation outcomes
• Engage with industry associations (Association of British HealthTech Industries — ABHI, MedTech Europe's UK working groups) for early intelligence on regulatory changes

Key advantage for CE-marked manufacturers: The indefinite CE recognition policy means that, for most manufacturers, maintaining a valid CE certificate is sufficient for UK market access. The additional UK-specific requirements (UKRP, MHRA registration, vigilance reporting) are administrative overlays, not technical reassessment. This makes the UK one of the more accessible major markets for manufacturers already compliant with EU requirements.

Practical Guidance for US Manufacturers Entering the UK

US-based medical device manufacturers face a different set of considerations when entering the UK market.

Step 1: Assess Your Regulatory Pathway

You have several options:

• Obtain CE marking from an EU Notified Body — this gives you access to both the EU and UK markets (since CE is accepted indefinitely in Great Britain). If you plan to sell in both Europe and the UK, this is often the most efficient approach.
• Obtain UKCA marking from a UK Approved Body — this gives you access to the Great Britain market only. Appropriate if you are targeting the UK specifically and do not plan to enter the EU market.
• Wait for the International Recognition Framework (IRF) — if implemented, the IRF may allow the MHRA to recognize FDA clearances/approvals as the basis for UK market access. However, the IRF is not yet in effect, and it would be imprudent to delay market entry based on this possibility.

Step 2: Understand the Quality System Requirements

The UK framework (both current and planned) is aligned with ISO 13485 for quality management systems. If your quality system is built on FDA 21 CFR Part 820 (now transitioning to QMSR/ISO 13485:2016), you may already be substantially compliant. Key gaps US manufacturers typically encounter:

US (FDA) Requirement	UK/ISO 13485 Requirement	Gap Assessment
21 CFR Part 820 / QMSR	ISO 13485:2016	Largely aligned under QMSR — gap analysis recommended for legacy 820 systems
Design History File (DHF)	Design and Development file	Largely equivalent — ensure documentation mapping
510(k) summary or PMA summary	CE/UKCA technical documentation	UK/EU technical documentation is more prescriptive and comprehensive than typical FDA submissions
FDA adverse event reporting (MDRs)	MHRA vigilance reporting	Different forms, timelines, and thresholds — dual reporting systems needed
FDA UDI (GUDID)	UK UDI (planned)	UDI requirements are similar in concept; UK system not yet fully implemented
US labeling (21 CFR 801)	UK labeling (UK MDR 2002, BS EN standards)	Significant differences in format, content, and language requirements

Step 3: Prepare Technical Documentation

UK conformity assessment (whether for CE or UKCA) requires technical documentation that is typically more comprehensive than an FDA 510(k) submission. Key elements include:

• Device description and specification (including all variants and accessories)
• Design and manufacturing information
• General Safety and Performance Requirements (GSPR) checklist with rationale for each requirement
• Risk management file (per ISO 14971)
• Verification and validation test reports
• Clinical evaluation report (CER)
• Labeling (labels, IFU, promotional materials)
• Post-market surveillance plan

If you have only FDA documentation, budget significant time and resources for preparing EU/UK-format technical documentation.

Step 4: Clinical Evidence Strategy

The UK (and EU) approach to clinical evidence differs from the FDA's in important ways:

• Clinical evaluation is mandatory for all device classes — not just high-risk devices
• Clinical evaluation reports (CERs) must follow a structured methodology (MEDDEV 2.7/1 Rev. 4 or equivalent)
• Equivalence claims — if you claim equivalence to a predicate device (similar to a 510(k) predicate), the UK/EU requirements for demonstrating equivalence are more stringent than the FDA's. You must demonstrate technical, biological, and clinical equivalence, and you must have access to the equivalent device's technical documentation (or be able to justify why access is not needed)
• Post-market clinical follow-up (PMCF) — required for most device classes, particularly Class IIb and III. This goes beyond the FDA's typical post-market requirements.

Step 5: Navigate the Practical Steps

1. Appoint a UKRP (mandatory for non-UK manufacturers)
2. Register with the MHRA
3. Ensure English-language labeling and IFU
4. Establish UK-specific vigilance reporting processes
5. Consider engaging a UK-based regulatory consultant for initial market entry — the nuances of the UK system post-Brexit can be challenging to navigate remotely

For FDA-cleared manufacturers watching the IRF: The proposed International Recognition Framework is the single most important UK regulatory development for US manufacturers. If the MHRA recognizes FDA decisions as a basis for UK market access, the regulatory burden for entering the UK could decrease dramatically. However, do not delay your UK market strategy based on this possibility alone — the timeline and scope of the IRF remain uncertain. Build your UK regulatory strategy based on current requirements, and position yourself to take advantage of the IRF if and when it becomes available.

Key Differences Between UK and EU Post-Market Obligations (Updated for June 2025 PMS Reform)

The June 2025 PMS overhaul brought UK post-market obligations significantly closer to the EU MDR's requirements. However, important differences remain for manufacturers operating in both markets:

Obligation	UK (from June 2025)	EU MDR
Incident reporting destination	MHRA (via MORE portal, GB data schemas from Oct 2025)	Competent Authority of the member state where the incident occurred
Reporting forms	MHRA MORE portal with IMDRF Annex codes, GMDN nomenclature, UDI data	MedDev forms / EUDAMED (when available)
Serious incident deadline (other)	15 calendar days (reduced from 30 in June 2025)	15 calendar days (aligned)
PSUR requirement	Now mandatory — PSUR for Class IIa+ (every 2 years for IIa, annually for IIb/III); PMSR for Class I (every 3 years)	Mandatory for Class IIa, IIb, III (every 2 years for IIa, annually for IIb/III)
PSUR format	MHRA standardised format (published June 2025)	EU MDR format
PSUR access	Must be available to MHRA within 3 working days on request	Must be available to Competent Authority on request
PMCF requirement	Expected as part of clinical evaluation but less prescriptive in legislation	Mandatory with detailed PMCF plan and evaluation report
SSCP (Summary of Safety and Clinical Performance)	Not currently required	Mandatory for Class III and implantable devices
Trend reporting	Required — GB-specific requirements with detailed initial and final reports, stricter follow-up timelines	Required — emphasises EU-wide coordination
PMS plan formality	Now mandatory — documented PMS plan with objectives, data sources, update frequency	Detailed, structured PMS plan required per Article 84
Record retention	15 years (implantable) / 10 years (other)	10 years minimum (15 for implantable)
Scope of reportable incidents	Broadened — includes malfunction/deterioration irrespective of potential for direct patient harm	Includes incidents that led, might have led, or might lead to serious harm

Key takeaway: The UK PMS framework is now substantially aligned with the EU MDR's PMS requirements, with a few notable exceptions (no SSCP requirement, less prescriptive PMCF requirements). Manufacturers maintaining EU MDR-compliant PMS systems will meet most UK requirements with minimal additional work — but should ensure GB-specific data fields, MHRA reporting formats, and UK record retention periods are properly addressed.

Frequently Asked Questions

Can I sell in both the UK and EU with a single CE certificate?

Yes, under the current framework. A valid CE certificate gives you access to the EU single market (including the EEA), Northern Ireland, and Great Britain (under the indefinite CE recognition policy). You will still need to appoint a UKRP and register with the MHRA for UK market access, but you do not need a separate UKCA certificate.

Do I need both a UKRP and an EU Authorized Representative?

If you are a non-UK, non-EU manufacturer, yes. These are separate legal requirements under separate regulatory frameworks. You need a UKRP for Great Britain and an EU AR for the EU market. The same organization may fulfill both roles if it has entities in both the UK and an EU member state.

What happens to my UKCA certificate if the new UK framework changes the rules?

The MHRA has committed to providing appropriate transition periods when the new framework is implemented. Existing UKCA certificates are expected to remain valid for a defined transition period, similar to how the EU managed the MDD-to-MDR transition. The specific transition arrangements will be detailed in the new legislation.

Is MHRA registration the same as market approval?

No. MHRA registration is an administrative requirement that provides the MHRA with visibility into devices on the UK market. It is not a review of your device's technical documentation, clinical evidence, or compliance. However, placing an unregistered device on the Great Britain market is a regulatory offence.

How does Brexit affect clinical investigations?

Clinical investigations in the UK are now authorized by the MHRA independently of any EU Clinical Investigation Assessment. If you are running a multisite study across the UK and EU, you need separate applications to the MHRA and the relevant EU member state Competent Authorities. Data generated in UK clinical investigations is generally accepted by EU Notified Bodies and EU Competent Authorities (and vice versa), but the regulatory submissions are separate.

Can a US manufacturer use an FDA clearance letter to access the UK market?

Not currently. FDA clearance/approval is not recognized as equivalent to CE or UKCA marking under the current framework. However, the proposed International Recognition Framework (IRF) is expected to change this. In October 2025, the MHRA announced a formal collaboration with the FDA to align regulatory processes. The pre-market SI (expected 2026) will establish the legal framework, with reliance routes — including recognition of FDA 510(k) clearances, De Novo classifications, and PMA approvals — expected to become operational from 2027.

What are the new registration fees from April 2026?

From 1 April 2026, the MHRA replaces its one-off £261 registration fee with an annual charge of approximately £300 per GMDN Level 2 Category. This fee is charged per category, not per individual device — if multiple products are registered under the same Level 2 Category, only one fee applies. Approximately 60% of manufacturers are expected to pay a single annual charge. Payment must be made via DORS within 90 days of 1 April. Non-payment leads to account suspension and loss of market access. Manufacturers should review and clean up their DORS registrations before 30 March 2026.

What are the new PMS requirements from June 2025?

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 came into force on 16 June 2025. Key requirements include: mandatory PMS plans for all devices; PMSR for Class I devices (updated every 3 years) and PSUR for Class IIa+ devices (every 2 years for IIa, annually for IIb/III); shortened incident reporting deadlines (15 calendar days, down from 30); broadened reportable incident scope; mandatory electronic reporting through the MORE portal using the new GB data schemas (mandatory from 16 October 2025); and record retention of 15 years for implantable devices and 10 years for others.

What is DORS and do I need to use it?

DORS (Device Online Registration System) is the MHRA's dedicated online portal for all medical device registration in Great Britain. All manufacturers placing devices on the GB market must register through DORS — either directly or through their UK Responsible Person. DORS is also where annual fees are calculated and paid from April 2026, and where manufacturers manage their registration data, GMDN codes, and account status.

Looking Ahead: The Future of UK Medical Device Regulation

The UK's regulatory framework for medical devices is now in active transformation. The June 2025 PMS overhaul was the first major legislative change; the upcoming pre-market Statutory Instrument in 2026 will be the second — and even more significant — reform. Together, these incremental changes are building the UK's first truly independent medical device regulatory regime.

Consolidated Regulatory Reform Timeline

Date	Milestone
16 June 2025	PMS regulations in force (first major overhaul)
16 October 2025	New GB data schemas mandatory for incident reporting
1 April 2026	New annual registration fee (~£300/GMDN Level 2 Category) replaces one-off fee
10 April 2026	CE marking indefinite recognition consultation closes
28 May 2026	Northern Ireland registration changes take effect
2026 (expected)	Pre-market SI laid before Parliament (after WTO notification); introduces IRF, updated classification rules, alignment with GSPRs, UDI requirements
2026	National Commission publishes AI in healthcare regulatory framework
Autumn 2026	Wider MHRA proposals expected, particularly SaMD/AIaMD regulation clarity
2027	International reliance routes (including FDA recognition) become operational
2027	IVD Roadmap deliverables continue through mid-2027

Key Developments to Watch

• Pre-market Statutory Instrument: The single most important upcoming legislative change. Expected to introduce up-classification of SaMD and implantable devices, the international recognition framework, alignment of Essential Requirements with EU MDR GSPRs, updated IVD classification rules, UDI requirements, implant cards, and strengthened technical documentation requirements.
• CE marking consultation outcome: The result of the February-April 2026 consultation will determine whether indefinite CE recognition becomes law, and whether it applies universally or with risk-based exceptions for devices classified differently in the UK.
• National Commission AI recommendations: Will shape the regulatory framework for AI as a Medical Device, with major implications for classification, evidence requirements, adaptive algorithm pathways, and liability.
• International Recognition Framework operationalization: Whether the 2027 target for FDA and other reliance routes holds, and the specific scope and conditions.
• IVD transition: How the shift from list-based to risk-based IVD classification is implemented, and the transition period given to manufacturers.
• MHRA fee model impact: How the new annual fee structure affects manufacturer behavior, particularly around DORS data quality and registration hygiene.
• UK Approved Body capacity: Whether the expanded roster of eight Approved Bodies is sufficient, particularly if UKCA becomes the primary route for first-in-market innovations.
• EU MDR/IVDR revision interaction: The EU's own ongoing revision of the MDR and IVDR (consultation closed March 2026) may affect UK-EU regulatory alignment and manufacturers' dual-market strategies.

What the Pre-Market Statutory Instrument Will Introduce

The government has confirmed the pre-market SI will introduce the following changes (expected to come into force in 2026, subject to WTO notification and Parliamentary scheduling):

• Up-classification of SaMD and implantable medical devices — resulting in stricter conformity assessment requirements for both device categories
• International Recognition Framework — new reliance routes for devices approved by trusted regulators (FDA, Health Canada, TGA Australia, EU Notified Bodies)
• Alignment of Essential Requirements with GSPRs — bringing GB requirements closer to the EU MDR's General Safety and Performance Requirements
• Updated IVD classification rules — moving toward risk-based classification for in vitro diagnostic devices
• UDI (Unique Device Identification) requirements — including implant cards for implantable devices
• Strengthened technical documentation requirements — more comprehensive documentation aligned with international standards
• Simplified requirements for Class I devices — reducing burden on low-risk devices
• Removal of physical UKCA marking requirement — once UDI is in place, physical UKCA markings on products and packaging will no longer be mandatory

UK Life Sciences Sector Plan and 10-Year Health Plan Context

The regulatory reforms are not happening in isolation. They reflect broader government commitments in:

• The Life Sciences Sector Plan — Committing to reduce unwarranted barriers to market entry and deliver transformative technologies to patients more quickly
• The 10-Year Health Plan for England — Committing to the NHS becoming the most AI-enabled healthcare system in the world, with a "front door to the entire NHS" by 2028, a new Health Store for centrally procured health apps, and up to £600 million for the Health Data Research Service
• NICE technology appraisal expansion — NICE's process will be expanded to cover digital tools, wearables, and diagnostics with mandated NHS funding for approved tools

These commitments create a favorable environment for manufacturers, particularly those developing digital health, AI, and diagnostic technologies for the UK market.

Strategic Recommendations for Manufacturers

1. Maintain your CE marking. With indefinite CE recognition now the expected policy direction, CE marking is the most efficient route to the UK market for the foreseeable future. Do not invest in UKCA marking unless you have a specific strategic reason (e.g., first-in-market AI device, or devices not CE marked).

2. Comply with the new PMS requirements now. The June 2025 PMS overhaul is in force. Ensure your PMS plan, PMSR/PSUR processes, and incident reporting systems (via the MORE portal, using the new GB data schemas) are fully compliant. The 15-day reporting deadline for serious incidents is a significant change from the previous 30 days.

3. Prepare for the April 2026 fee transition. Review your DORS registrations immediately. Unregister obsolete devices, verify GMDN codes and Level 2 Category assignments, and finalize or delete draft applications before 30 March 2026. Budget for the new annual ~£300/category charge.

4. Invest in monitoring. The UK regulatory landscape is changing rapidly — PMS regulations in June 2025, fee changes in April 2026, a pre-market SI expected in 2026, the AI Commission reporting in 2026, and wider proposals in Autumn 2026. Dedicate regulatory affairs resources to tracking MHRA publications, consultations, and guidance updates.

5. Engage with the MHRA. The MHRA under Lawrence Tallon's leadership is accessible and actively seeking industry engagement. Take advantage of pre-submission meetings, the AI Airlock, MHRA-led workshops (such as the SoGATS workshops for IVD manufacturers), and consultation opportunities.

6. Watch the IRF and MHRA-FDA collaboration. For US manufacturers especially, the International Recognition Framework with reliance routes expected from 2027 could be transformative. The formal MHRA-FDA partnership announced in October 2025 is a strong signal. Position yourself to take advantage of reliance routes as soon as they become available.

7. Northern Ireland requires EU compliance. If you sell into Northern Ireland, you must comply with EU MDR or IVDR — not just the UK MDR 2002. Note the new Northern Ireland registration requirements taking effect 28 May 2026 and the particular complexity for drug-device combination products under the Windsor Framework.

8. Respond to the CE marking consultation. The MHRA's consultation on indefinite CE recognition is open until 10 April 2026. Manufacturers should participate, particularly regarding whether indefinite recognition should apply universally or only to devices classified at the same or lower risk under UK rules.

The UK represents a significant market — the NHS is the largest single-payer healthcare system in Europe, and the UK's medical technology sector is one of the largest globally. The regulatory framework is evolving, but the MHRA's stated commitment to proportionate, innovation-friendly regulation, combined with the indefinite CE recognition policy, makes the UK accessible to manufacturers who plan carefully and stay informed.