EU MDR and IVDR: The Complete Guide to European Medical Device Regulation

Why EU MDR and IVDR Matter

If you sell medical devices or in vitro diagnostics in Europe, every decision you make — from design inputs to post-market surveillance — is shaped by two regulations: the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).

These regulations replaced a framework that had been in place since the 1990s. The old system — built on the Medical Devices Directive (MDD 93/42/EEC), the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC), and the In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) — had real gaps. The PIP breast implant scandal, the metal-on-metal hip implant failures, and inconsistencies in how Notified Bodies applied conformity assessment across member states all made the case that Europe needed a stronger regulatory architecture.

The MDR and IVDR are the result. They are not minor updates. They are a wholesale rewrite of how medical devices reach and remain on the European market.

This guide covers everything manufacturers need to know: what changed, how devices are classified, what conformity assessment entails, what your technical documentation must contain, how the transition timeline works as of 2026, and what post-market obligations look like in practice.

What EU MDR and IVDR Replaced

The Old Framework

The previous system was directive-based. Directives set objectives but left implementation details to individual EU member states, which created inconsistencies. Three directives governed the space:

Old Directive	Scope	Replaced By
MDD 93/42/EEC	General medical devices (including accessories)	MDR (EU) 2017/745
AIMDD 90/385/EEC	Active implantable medical devices	MDR (EU) 2017/745
IVDD 98/79/EC	In vitro diagnostic medical devices	IVDR (EU) 2017/746

Why the Change Was Necessary

The directives had served Europe for over two decades, but several structural weaknesses became impossible to ignore:

• Inconsistent Notified Body oversight. Under the MDD, Notified Bodies were designated and supervised by national Competent Authorities with varying levels of rigor. A manufacturer could — and did — shop for the most accommodating Notified Body across member states.
• Weak pre-market scrutiny for higher-risk devices. The MDD classification system, while functional, allowed some higher-risk devices (particularly implantables) to reach market with less clinical evidence than the risk warranted.
• No centralized device database. There was no EU-wide system for tracking devices, certificates, or incidents. Traceability was fragmented across national databases.
• Limited post-market obligations. The MDD required post-market surveillance in principle, but the requirements lacked specificity. Many manufacturers treated PMS as a checkbox exercise.
• No Unique Device Identification. Unlike the FDA's UDI system, Europe had no standardized device identification scheme.

The MDR and IVDR address all of these. They are regulations — directly applicable in all member states without transposition — and they are significantly more detailed than the directives they replaced.

Key Changes: MDD to MDR at a Glance

Area	MDD (Old)	MDR (New)
Legal instrument	Directive (transposed by member states)	Regulation (directly applicable)
Scope	Medical devices, accessories	Expanded: includes certain aesthetic devices, devices without intended medical purpose (Annex XVI)
Classification	4 classes (I, IIa, IIb, III) — 18 rules	4 classes — 22 rules with expanded criteria
Clinical evidence	Less prescriptive; clinical data not always required for Class I/IIa	Clinical evaluation mandatory for all classes; clinical investigations for implants and Class III unless justified
Technical documentation	Annex-based but less detailed	Annexes II and III — highly prescriptive, specific content requirements
Post-market surveillance	General obligation, limited specifics	Detailed PMS plan, PMCF, PSUR requirements by risk class
UDI	Not required	Mandatory UDI-DI and UDI-PI system
EUDAMED	No centralized database	Centralized EU database (phased rollout)
Notified Body oversight	National designation, variable scrutiny	Joint assessments, stricter designation criteria, unannounced audits
Economic operators	Manufacturer, Authorized Representative	Expanded: manufacturer, AR, importer, distributor — all with defined obligations
Traceability	Limited	Full traceability through supply chain via UDI
Transparency	Minimal public access	Summary of Safety and Clinical Performance (SSCP) for implants and Class III
Person Responsible for Regulatory Compliance	Not required	Mandatory PRRC with defined qualifications

MDR Device Classification

The MDR uses a risk-based classification system with four classes: Class I (lowest risk), Class IIa, Class IIb, and Class III (highest risk). Classification is determined by applying 22 rules set out in Annex VIII, grouped by device type.

Classification Rules Overview

Rule Group	Rules	Covers
Non-invasive devices	Rules 1–4	Devices that do not penetrate the body (wound dressings, collection devices, devices that channel or store substances)
Invasive devices	Rules 5–8	Body orifice devices, surgically invasive devices (transient, short-term, long-term)
Active devices	Rules 9–13	Therapeutic devices, diagnostic devices, devices that administer or exchange energy, software
Special rules	Rules 14–22	Contraceptives, disinfectants, devices with animal/human tissue, nanomaterials, substances administered into the body, etc.

Key Classification Principles

Rule 11 (Software) deserves special attention. Under the MDR, standalone software intended to provide information used to make decisions with diagnosis or therapeutic purposes is classified as follows:

• Class III — if the decision could cause death or irreversible deterioration of health
• Class IIb — if the decision could cause serious deterioration of health or surgical intervention
• Class IIa — all other diagnostic/therapeutic decision software
• Class I — software not meeting the above criteria

This is a significant up-classification from the MDD era, where most standalone software was Class I or Class IIa. Many software manufacturers discovered they were now Class IIa or IIb, requiring Notified Body involvement for the first time.

Rule 8 (Implantable devices) generally drives devices to Class IIb or Class III. Long-term surgically invasive devices in contact with the heart, central circulatory system, or central nervous system are Class III. Implantable devices and long-term surgically invasive devices are generally Class IIb, with exceptions that push them to Class III.

Practical tip: Classification is the first decision that shapes your entire regulatory strategy. Get it wrong, and everything downstream — conformity assessment route, Notified Body involvement, clinical evidence requirements — is built on a flawed foundation. If there is any ambiguity, engage your Notified Body or Competent Authority early. The MDR's classification rules interact in ways that are not always intuitive, and Rule 11 in particular has caught many software companies off guard.

IVDR Device Classification

The IVDR introduced a completely new risk-based classification system for in vitro diagnostics, replacing the IVDD's list-based approach. Under the IVDD, most IVDs were self-certified by manufacturers — only devices on Annex II List A or List B required Notified Body involvement. The IVDR fundamentally changes this.

IVDR Classification Rules

The IVDR classifies IVDs into four classes: A (lowest risk), B, C, and D (highest risk), based on seven rules in Annex VIII.

Class	Risk Level	Examples	Notified Body Required?
D	Highest	Blood grouping (ABO, Rh), HIV/HCV/HBV screening for transfusion, variant CJD testing	Yes
C	High	Companion diagnostics, self-testing for blood glucose, HLA typing, tumor markers for staging, prenatal screening (trisomy 21)	Yes
B	Moderate	Self-testing (pregnancy tests, cholesterol), clinical chemistry analyzers, blood gas analyzers, hematology systems	Yes
A	Lowest	General lab reagents, specimen receptacles, buffer solutions, wash solutions, general culture media	No (self-declaration) — unless sterile (As)

The Up-Classification Problem

Under the IVDD, roughly 80% of IVDs were self-certified. Under the IVDR, an estimated 80% now require Notified Body involvement. This inversion has created the single biggest bottleneck in the IVDR transition:

• There are very few Notified Bodies designated for IVDR. As of early 2026, only a handful have full IVDR designation, compared to dozens under the old IVDD system.
• The sheer volume of devices that now require Notified Body review has overwhelmed available capacity.
• IVD manufacturers — many of whom had never worked with a Notified Body before — are learning an entirely new conformity assessment process.

Reality check: If you are an IVD manufacturer with Class B, C, or D devices, securing Notified Body capacity is not a regulatory formality — it is a strategic business priority. Some manufacturers have reported 12–18 month wait times just to initiate a conformity assessment. Plan accordingly.

Conformity Assessment Routes

Conformity assessment is the process by which a manufacturer demonstrates that its device complies with the applicable regulation. The route depends on the device classification.

MDR Conformity Assessment Pathways

Device Class	Conformity Assessment Route	Annex	Notified Body Role
Class I (non-sterile, non-measuring, non-reusable surgical)	Self-declaration	Annex IV (EU Declaration of Conformity)	None
Class I (sterile, measuring function, or reusable surgical)	Self-declaration + NB for specific aspects	Annex IV + relevant sections of Annex IX or XI	NB reviews sterile/measuring/reprocessing aspects only
Class IIa	Quality management system assessment OR product verification	Annex IX (Chapters I and III) or Annex XI (Section 10)	Full QMS audit, technical documentation sampling
Class IIb	QMS assessment + technical documentation assessment	Annex IX (Chapters I and II) or Annex X + XI (Section 10)	Full QMS audit + full technical documentation review for at least one representative device per generic device group
Class III	QMS assessment + technical documentation assessment for each device	Annex IX (Chapters I and II) or Annex X + XI (Part A)	Full QMS audit + individual review of technical documentation for every device

Scrutiny Procedure (Article 54)

For Class III implantable devices and Class IIb active devices intended to administer or remove a medicinal product, the MDR introduces a "scrutiny procedure." After the Notified Body completes its assessment and is satisfied, it must notify the relevant Competent Authority and provide the clinical evaluation assessment report and the manufacturer's documentation. The Competent Authority and, in some cases, expert panels can review and comment on the assessment.

This is new under the MDR and reflects Europe's intent to add an additional layer of oversight for the highest-risk devices.

IVDR Conformity Assessment Pathways

Device Class	Conformity Assessment Route	Notified Body Role
Class A (non-sterile)	Self-declaration	None
Class A sterile	Self-declaration + NB for sterile aspects	NB reviews sterile manufacturing aspects
Class B	Annex IX (QMS + technical documentation assessment)	Full QMS audit, technical documentation review
Class C	Annex IX (QMS + technical documentation assessment)	Full QMS audit, full technical documentation review
Class D	Annex IX (QMS + technical documentation assessment) + batch verification for certain devices	Full QMS audit, full technical documentation review, batch verification where applicable

Technical Documentation Requirements

The MDR and IVDR specify technical documentation requirements in meticulous detail across two annexes.

Annex II: Technical Documentation

Annex II sets out the content that must be included in the technical documentation for every device. It is organized into sections:

1. Device description and specification — intended purpose, intended users, patient population, contraindications, variants and accessories, description of each component material, functional principles
2. Information to be supplied by the manufacturer — labeling, IFU, packaging design
3. Design and manufacturing information — manufacturing processes, facilities, critical suppliers, in-process controls, validation of manufacturing processes (especially sterilization, biocompatibility processing, software validation)
4. General safety and performance requirements (GSPR) — a checklist demonstrating compliance with each applicable requirement in Annex I, with references to the standards and evidence used
5. Benefit-risk analysis and risk management — the complete risk management file per ISO 14971, including the benefit-risk determination
6. Product verification and validation — all pre-clinical and clinical data, bench testing, biocompatibility testing, electrical safety, EMC, software verification and validation, usability testing

Annex III: Post-Market Surveillance Documentation

Annex III defines the requirements for the PMS plan and PMS report (or PSUR for Class IIa, IIb, and III devices). This is a separate, maintained document — not a static filing. It must describe:

• Systematic processes for collecting and analyzing post-market data
• Methods for identifying trends, including statistically significant increases in serious incidents
• Effective and timely field safety corrective actions
• Integration with the risk management system and clinical evaluation updates

General Safety and Performance Requirements (GSPR)

Annex I of the MDR contains 23 general safety and performance requirements — the GSPR. These replace the "Essential Requirements" of the MDD. The GSPR cover:

• General requirements (risk management approach, design for safety, reduction of risks)
• Requirements regarding design and manufacture (chemical, physical, biological properties; infection and microbial contamination; devices incorporating substances; energy delivery; software; connected devices; mechanical properties)
• Requirements regarding information supplied with the device (labeling, IFU)

Every manufacturer must produce a GSPR checklist — a document mapping each of the 23 requirements (and their sub-clauses) to:

• Whether the requirement applies to the specific device
• The harmonized standard(s) or common specification(s) used to demonstrate compliance
• The specific evidence referenced (test reports, clinical data, risk management file sections)

Common pitfall: Many manufacturers treat the GSPR checklist as a boilerplate exercise, using vague references like "See risk management file." Notified Bodies have become increasingly rigorous about requiring specific, traceable references. Each line should point to a specific document, section, and version. A well-constructed GSPR checklist is one of the most reliable indicators of regulatory maturity.

UDI and EUDAMED

Unique Device Identification (UDI)

The MDR and IVDR introduce a mandatory UDI system modeled on — but not identical to — the FDA's UDI framework. The UDI has two components:

• UDI-DI (Device Identifier) — identifies the manufacturer and the specific device model/variant. This is a static identifier assigned to the device label.
• UDI-PI (Production Identifier) — identifies the specific unit of production (lot/batch number, serial number, expiration date, manufacturing date, as applicable). This is dynamic and changes per production run.

UDI implementation timelines under the MDR:

Device Class	UDI Carrier on Label	UDI Registration in EUDAMED
Class III and implantable	Required since MDR application date	Required (when EUDAMED module available)
Class IIa and IIb	Required	Required (when EUDAMED module available)
Class I	Required	Required (when EUDAMED module available)

The UDI must appear on the device label and on all higher levels of packaging. For reusable devices that are reprocessed between uses, the UDI carrier must be placed on the device itself and must be readable after each reprocessing cycle.

UDI On-Device Marking Timeline

In addition to labeling, the MDR requires UDI carriers to be placed directly on the device itself (Direct Marking), with staggered deadlines:

Device Class	UDI on Device Itself
Class III and implantable devices	Required since May 26, 2023
Class IIa and Class IIb devices	Required since May 26, 2025
Class I devices	Required from May 26, 2027

The accredited UDI issuing entities are GS1, HIBCC, ICCBBA, and IFA. Manufacturers must assign a Basic UDI-DI (identifying the device model at the highest level) and UDI-DIs for each variant and packaging configuration. UDI-DI and UDI-PI codes must follow international standards and should be integrated into ERP, labeling, and supply chain systems.

EUDAMED

The European Database on Medical Devices (EUDAMED) is the centralized IT system that underpins the MDR and IVDR. It is designed to have six modules:

1. Actor registration — registration of manufacturers, Authorized Representatives, importers
2. UDI/device registration — device identification data linked to UDI-DIs
3. Notified Bodies and certificates — database of designated Notified Bodies and certificates issued
4. Clinical investigations/performance studies — registration and reporting
5. Vigilance and post-market surveillance — incident reporting and field safety corrective actions
6. Market surveillance — Competent Authority market surveillance activities

EUDAMED has been subject to years of delays, but 2026 marks a decisive turning point. On November 27, 2025, the European Commission published Commission Decision (EU) 2025/2371, formally declaring the first four EUDAMED modules fully functional. Under the transitional provisions of Regulation (EU) 2024/1860, this triggered a six-month countdown. From May 28, 2026, four EUDAMED modules become mandatory:

1. Actor Registration — all economic operators (manufacturers, ARs, importers, system and procedure pack producers) must register and obtain a Single Registration Number (SRN)
2. UDI/Device Registration — all devices placed on the EU market must be registered at the UDI-DI level
3. Notified Bodies and Certificates — all certificates must be uploaded by Notified Bodies
4. Market Surveillance — Competent Authority market surveillance coordination

The remaining two modules — Vigilance and Clinical Investigations/Performance Studies — are still under development. They will become mandatory following a separate functionality notice and transition period, with no voluntary use phase prior to mandatory application.

EUDAMED Mandatory Deadlines

Deadline	Obligation
May 28, 2026	Actor registration mandatory — all economic operators must have an SRN. New devices must be registered in the UDI/Device module before being placed on the EU market. NBs begin uploading new certificates.
November 28, 2026	Legacy devices (MDD/AIMDD/IVDD devices already on the market before May 28, 2026) must be registered in the UDI/Device module.
May 28, 2027	NBs must complete uploading certificates issued before May 2026.
TBD	Functionality declaration for Vigilance and Clinical Investigation modules (separate notice and transition).

Without actor registration and an SRN, device registration cannot proceed, and without device registration, market access for new devices is blocked. National databases will gradually be replaced by centralized EUDAMED processes.

Practical tip: EUDAMED is no longer a future system — it is an immediate operational priority. If you have not yet registered as an Actor and obtained your SRN, begin immediately. For manufacturers with large portfolios, the data migration and validation effort for UDI/device registration is substantial. Companies that treat the May 28, 2026 deadline as a project start date rather than a completion date will face compliance gaps and potential market access disruption.

The Transition Timeline: Where We Stand in 2026

The MDR and IVDR transition has been one of the most complex — and most delayed — regulatory transitions in the history of the medical device industry. Understanding the current state of play requires tracking multiple overlapping timelines.

MDR Transition Timeline

The MDR transition deadlines have been amended twice — first by Regulation (EU) 2023/607 in March 2023, and then by Regulation (EU) 2024/1860 in June 2024. The current operative deadlines as of 2026 are:

Date	Event
May 25, 2017	MDR published in Official Journal of the EU
May 26, 2021	MDR date of application (after 1-year COVID delay from original May 2020 date)
May 26, 2024	Deadline for manufacturers to have applied to a Notified Body for MDR certification
September 26, 2024	Deadline for manufacturers to have a signed written agreement with a Notified Body
May 26, 2026	Deadline for custom-made Class III implantable devices to fully comply with MDR
December 31, 2027	Extended deadline for Class III and Class IIb implantable devices (excluding well-established technologies) with valid MDD/AIMDD certificates as of March 20, 2023
December 31, 2028	Extended deadline for Class IIb (non-implantable), Class IIa, Class I sterile, Class I measuring, and up-classified Class I devices
May 26, 2029	Final sell-off deadline — devices lawfully placed on the market before the applicable transition deadline may continue to be made available on the market or put into service

The Extension Regulations: (EU) 2023/607 and (EU) 2024/1860

In March 2023, the European Commission adopted Regulation (EU) 2023/607, which first amended the MDR transition provisions. This was a direct response to the capacity crisis: too few Notified Bodies, too many devices to certify, and a real risk of device shortages. In June 2024, Regulation (EU) 2024/1860 further amended both the MDR and IVDR, introducing additional changes. The combined effect of these amendments:

• Removed the fixed expiry date for legacy MDD/AIMDD certificates (previously May 26, 2024)
• Introduced staggered deadlines based on device class (December 2027 for high-risk, December 2028 for medium/lower-risk)
• Required manufacturers to have applied to a Notified Body for MDR certification by May 26, 2024, and to have a signed written agreement with a Notified Body by September 26, 2024
• Required manufacturers to have a QMS and PMS system in place that meets MDR requirements, even while operating under legacy certificates
• Required that no significant changes be made to the device's design or intended purpose while under transitional provisions
• Introduced EUDAMED module-by-module mandatory activation (triggered by functionality notices)
• Added Article 10a supply interruption notification obligations (effective January 10, 2025)
• Extended the sell-off date to May 26, 2029

Conditions for Benefiting from Extended MDR Transition

Manufacturers cannot automatically benefit from the extended deadlines. They must meet all of the following conditions simultaneously under Article 120(3c):

1. The device continues to comply with the applicable directive (MDD or AIMDD)
2. No significant changes have been made to the device's design or intended purpose
3. The device does not present an unacceptable risk to health or safety
4. The manufacturer has a QMS in place compliant with MDR requirements
5. The manufacturer applied to a Notified Body for MDR conformity assessment by May 26, 2024
6. A signed written agreement with a Notified Body was in place by September 26, 2024

Failing to meet any of these conditions means the legacy device may no longer be placed on the EU market and must undergo a fresh MDR conformity assessment application.

IVDR Transition Timeline

The IVDR transition deadlines were also significantly extended by Regulation (EU) 2024/1860:

Date	Event
May 25, 2017	IVDR published in Official Journal of the EU
May 26, 2022	IVDR date of application
May 26, 2025	Application deadline for Class D manufacturers (must have applied to NB)
September 26, 2025	Deadline for Class D manufacturers to have signed agreement with NB
December 31, 2027	Extended deadline for Class D devices and devices with valid IVDD certificates
May 26, 2026	Application deadline for Class C manufacturers
September 26, 2026	Deadline for Class C manufacturers to have signed agreement with NB
December 31, 2028	Extended deadline for Class C devices
May 26, 2027	Application deadline for Class B and Class A sterile manufacturers
September 26, 2027	Deadline for Class B/A sterile manufacturers to have signed agreement with NB
December 31, 2029	Extended deadline for Class B and Class A sterile devices
May 26, 2030	IVDR sell-off deadline

The IVDR transition is even more challenging than the MDR transition, primarily because so many IVD manufacturers had no prior Notified Body relationship and the number of designated IVDR Notified Bodies remains critically low. The three-year extension provided by Regulation (EU) 2024/1860 was explicitly designed to prevent IVD shortages that could directly harm patient care.

Current Situation (Early 2026)

As of March 2026, the industry faces an unprecedented convergence of regulatory obligations:

• MDR: Custom-made Class III implantable devices face a May 26, 2026 compliance deadline. For other high-risk legacy devices, the December 2027 deadline is close enough that manufacturers without active Notified Body reviews are at serious risk. Notified Bodies report average MDR certification review times of 13 to 18 months, meaning manufacturers who have not yet submitted complete applications may not receive certificates in time.
• IVDR: Class D devices must now meet IVDR requirements (applications due by May 2025, agreements by September 2025, transition ends December 2027). Class C devices face application deadlines in May 2026. The number of IVDR-designated Notified Bodies remains critically low, and IVD shortages in certain diagnostic categories are a genuine concern for healthcare systems.
• EUDAMED mandatory go-live: From May 28, 2026, four EUDAMED modules become mandatory under Decision (EU) 2025/2371. This is a structural shift — actor registration, UDI/device registration, NB certificate uploads, and market surveillance data must flow through EUDAMED. This alone represents a major compliance project for many manufacturers.
• Article 10a supply interruption notifications: Since January 10, 2025, manufacturers must notify Competent Authorities and downstream economic operators at least six months before any anticipated supply interruption or discontinuation that could cause serious harm to patients or public health. This applies to both MDR/IVDR-certified devices and legacy devices.
• Notified Body capacity: This remains the single biggest systemic constraint. As of 2025, approximately 51 Notified Bodies are designated under MDR and 19 under IVDR, but they are collectively handling an estimated 28,500 certification applications with only about 43% resulting in certificates. Certification timelines average 13-18 months, and incomplete submissions extend timelines further.
• MDR/IVDR 2.0 simplification proposal: On December 16, 2025, the European Commission published COM(2025) 1023 — a comprehensive proposal to amend the MDR and IVDR. The proposal is now before the European Parliament and Council (see the "Proposed MDR/IVDR Simplification" section below for details).

Strategic advice: 2026 is shaping up to be the most demanding regulatory year since the MDR entered into force. The convergence of transition deadlines, mandatory EUDAMED go-live, Article 10a obligations, and ongoing Notified Body bottlenecks means manufacturers must treat regulatory compliance as a business-critical program — not a background function. Manufacturers who wait until the last months before a deadline risk being unable to find Notified Body capacity and may face forced market withdrawal.

Role of Notified Bodies

Notified Bodies are the private-sector organizations designated by EU member states to carry out conformity assessments for medical devices that require third-party review. Under the MDR and IVDR, their role has expanded and the requirements for their designation have become far more stringent.

What Changed Under MDR/IVDR

• Joint assessments for designation: Notified Bodies are now designated through a joint assessment involving the national Competent Authority, the European Commission, and a team of experts from other member states. This eliminates the inconsistency of the old national-only designation process.
• Stricter competency requirements: Notified Bodies must demonstrate competency by device category and technology. They cannot operate outside their designated scope.
• Unannounced audits: Notified Bodies must conduct unannounced audits of manufacturers at least once every five years (at minimum). They may also conduct unannounced testing of device samples.
• Technical documentation review: For Class IIb and III devices, Notified Bodies must review the full technical documentation — not just the QMS. For Class IIa, they review technical documentation on a representative sampling basis.
• Clinical evaluation assessment: Notified Bodies must include qualified clinicians in their assessment teams for devices requiring clinical evaluation. For Class III and implantable devices, the clinical evaluation assessment report (CEAR) may also be subject to scrutiny by expert panels.

Notified Body Capacity: The Numbers

Year	Approximate MDR-Designated Notified Bodies	Approximate IVDR-Designated Notified Bodies
2021	6	0
2022	15	1
2023	30	4
2024	38	6
2025	51	19
2027 (projected)	~85	~30+
2028 (projected)	100+	40+

For comparison, approximately 50-60 Notified Bodies were active under the MDD, and many of those had broader scopes. The raw number of designated bodies only tells part of the story. The critical metrics are:

• Application volume: As of 2025, an estimated 28,500 MDR/IVDR certification applications are being processed across all Notified Bodies.
• Certificate issuance rate: Only approximately 43% of applications result in issued certificates. Incomplete or insufficient submissions are a leading cause of delays.
• Average review time: 13-18 months for a successful MDR certification, longer for complex or novel devices.
• Device population: Europe has approximately 38,000 medical device companies and over 500,000 devices in circulation. Roughly 80% of these devices are still certified under legacy directives and must transition.
• Re-certification burden: From 2026 to 2029, Notified Bodies must handle re-certifications for devices already certified under MDR/IVDR while simultaneously processing the remaining transition backlog. This dual demand is expected to create an additional bottleneck.

The European Commission's 2025 Notified Bodies Survey (covering all 51 designated MDR Notified Bodies) confirmed rising application volumes but also ongoing challenges with documentation quality and capacity constraints. Projections suggest NB numbers could rise to 85 by 2027 and over 100 by 2028, but even under optimistic assumptions, more than 114,000 certification applications are expected by 2028 — leaving each Notified Body responsible for an average of more than 900 certifications.

Choosing a Notified Body

When selecting a Notified Body, consider:

1. Scope of designation — Does the NB's designated scope cover your specific device type and technology?
2. Capacity and timeline — What is their current backlog? When can they realistically begin your assessment?
3. Technical expertise — Do they have staff with relevant clinical and technical expertise for your device category?
4. Geographic considerations — While any EU-designated NB can certify for the entire EU market, having a NB in a member state where you have operations can simplify communication and audit logistics.
5. Pricing transparency — MDR conformity assessment costs have increased substantially. Get detailed quotes and understand the fee structure (initial assessment, annual surveillance, unannounced audits, certificate modifications).

Authorized Representative Requirements

Non-EU manufacturers must appoint an Authorized Representative (AR) established in the EU. The MDR significantly expanded the AR's responsibilities compared to the MDD.

AR Obligations Under MDR

• Verify that the EU Declaration of Conformity and technical documentation have been drawn up
• Keep available a copy of the technical documentation, the EU Declaration of Conformity, and (if applicable) the relevant certificate issued by a Notified Body
• Comply with registration obligations (Article 31) and provide information to Competent Authorities upon request
• Cooperate with Competent Authorities on preventive or corrective actions
• Forward complaints and reports of suspected incidents to the manufacturer
• Terminate the mandate if the manufacturer acts contrary to its obligations under the regulation

The AR must have a written mandate from the manufacturer specifying these responsibilities. The mandate must also allow the AR to be addressed by Competent Authorities alongside or instead of the manufacturer on regulatory matters.

Important consideration: Under the MDR, the AR role carries real liability. This is not a mailbox address — the AR can be held responsible if the manufacturer is not properly fulfilling its obligations. Choose an AR with genuine regulatory competency and the operational capacity to fulfill the mandate. Many manufacturers have discovered that their existing low-cost AR arrangements are inadequate for MDR.

Post-Market Obligations

The MDR and IVDR significantly strengthened post-market surveillance requirements. These are not optional activities — they are legal obligations with specific deliverables and timelines.

Post-Market Surveillance (PMS) Plan

Every manufacturer must establish, document, implement, and maintain a PMS system proportionate to the risk class and type of device. The PMS plan must include:

• A proactive and systematic process for collecting data on quality, performance, and safety
• Effective and appropriate methods for gathering data from marketed devices (complaint analysis, literature review, registry data, experience from similar devices)
• Indicators and thresholds for statistical analysis and trend identification
• Methods for investigating complaints and field safety actions by other manufacturers
• Procedures for communicating with Competent Authorities, Notified Bodies, and economic operators

PMS Reports and PSURs

Deliverable	Applicable To	Frequency	Content
PMS Report	Class I devices	Updated as necessary	Summary of PMS results and conclusions, description of preventive and corrective actions taken
Periodic Safety Update Report (PSUR)	Class IIa, IIb, III devices	Class IIa: at least every 2 years; Class IIb and III: at least annually	Conclusions of benefit-risk analysis, main findings of PMCF, volume of sales, serious incident summary, trend analysis, actions taken

Post-Market Clinical Follow-up (PMCF)

PMCF is a continuous process that updates the clinical evaluation throughout the device lifecycle. It is mandatory for all device classes, though the scope and methods should be proportionate to the risk.

PMCF methods include:

• Clinical investigations (PMCF studies) designed to address specific clinical questions
• Review of published literature and clinical registries
• Analysis of complaint and incident data for clinical signals
• Surveys and questionnaires to device users

The PMCF evaluation report must be part of the clinical evaluation report and must be updated at defined intervals. For implantable devices and Class III devices, the PMCF plan and report are subject to Notified Body review and must be available via EUDAMED.

Summary of Safety and Clinical Performance (SSCP)

For implantable devices and Class III devices, the MDR requires manufacturers to prepare a Summary of Safety and Clinical Performance (SSCP). This is a publicly accessible document, intended to be understandable by both healthcare professionals and, where applicable, patients. The SSCP must include:

• A summary of the clinical evaluation, including an assessment of the benefit-risk profile
• Suggested patient profiles and information for users (training, experience, education)
• A description of the device, including its intended purpose and any indications, contraindications, or warnings
• Alternatives to the device and a comparison of outcomes where available
• References to harmonized standards and common specifications applied

The SSCP must be validated by the Notified Body as part of the conformity assessment and updated when the clinical evaluation is updated. Once EUDAMED is fully operational, the SSCP must be uploaded to the database and made publicly accessible. The SSCP is a transparency tool — it gives patients and healthcare professionals direct access to safety and performance information that was historically buried in technical files.

Post-Market Performance Follow-up (PMPF) — IVDR

The IVDR equivalent of PMCF is Post-Market Performance Follow-up (PMPF). The structure mirrors PMCF but focuses on performance characteristics: analytical sensitivity and specificity, diagnostic sensitivity and specificity, accuracy, repeatability, reproducibility, lot-to-lot variation, and interference/cross-reactivity behavior over time.

Vigilance Reporting

Manufacturers must report:

• Serious incidents — within 15 days of becoming aware (or within 10 days for serious public health threats, or within 2 days for imminent risk of death)
• Field Safety Corrective Actions (FSCAs) — any corrective action taken for safety reasons must be reported and a Field Safety Notice distributed to affected parties
• Trend reports — statistically significant increases in the frequency or severity of non-serious incidents or expected undesirable side effects must be reported

Person Responsible for Regulatory Compliance (PRRC)

The MDR introduces a new requirement: every manufacturer must have at least one Person Responsible for Regulatory Compliance (PRRC) within its organization. The PRRC must have expertise demonstrated by:

• A diploma, certificate, or other evidence of formal qualification in law, medicine, pharmacy, engineering, or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or QMS for medical devices; or
• Four years of professional experience in regulatory affairs or QMS for medical devices

The PRRC is responsible for ensuring that:

• The conformity of devices is appropriately checked before release
• Technical documentation and the EU Declaration of Conformity are drawn up and kept up to date
• PMS obligations are fulfilled
• Reporting obligations (vigilance) are fulfilled
• The statement required under Article 52(4)(a) is issued (for investigational devices)

Micro and small enterprises that do not employ a PRRC full-time may contract with an external PRRC, provided the external person can fulfill the responsibilities effectively.

Note on the proposed simplification: The December 2025 MDR/IVDR reform proposal (COM(2025) 1023) includes provisions to relax the detailed qualification requirements for the PRRC and to remove the obligation that SMEs relying on an external PRRC must have that person "permanently and continuously" available. Under the proposal, the external PRRC would only need to be "available." This change, if adopted, would improve access to regulatory expertise for smaller companies. However, the proposal has not yet been adopted — current requirements remain in force.

Implant Card Requirements (Article 18)

The MDR introduces a new requirement for manufacturers of implantable devices to provide an implant card — a wallet-sized card containing essential information for patients who have received an implanted device. This requirement, set out in Article 18, is one of the MDR's most patient-facing obligations.

What the Implant Card Must Contain

The manufacturer must provide the following information on or with the implant card:

• Device identification: device name, device type, serial number (or lot/batch number where applicable), UDI (in both automatic identification and data capture format such as 2D barcode and human-readable UDI-DI), device model
• Manufacturer information: name, address, and website of the manufacturer
• Warnings and precautions: any measures to be taken by the patient or healthcare professional regarding interference with external influences, medical examinations (e.g., MRI compatibility), or environmental conditions
• Expected lifetime: information about the expected lifetime of the device and any necessary follow-up
• Safe use information: any other information to ensure safe use by the patient

The card must also include blank fields to be filled in by the healthcare institution or provider:

• Patient name or ID
• Date of implantation
• Name and address of the healthcare institution where the implantation was performed

Format Requirements

Per MDCG 2019-8 guidance, the implant card must be:

• The size of a credit card, ATM card, or ID card (85.60 mm x 53.98 mm)
• Written in language(s) determined by the relevant Member State
• Written in a way that is readily understood by a lay person
• Updated as appropriate, with updates made available via the manufacturer's website

Exemptions

Article 18(3) exempts the following implants from the implant card requirement: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. The Commission may amend this list through delegated acts.

Healthcare Institution Obligations

Member States must require health institutions to provide patients with the implant card and the associated patient information. For Class III implantable devices, health institutions are required to store and keep the UDI (preferably electronically) under Article 27(9). For other classes, Member States may encourage or require this.

Practical tip: Manufacturers should not underestimate the operational complexity of the implant card requirement. It requires coordination between labeling, regulatory affairs, and supply chain teams. The card must be supplied with every individual device, in the correct language for the destination market, with UDI barcodes that are scannable. Companies like Johnson & Johnson MedTech have implemented electronic Patient Information Leaflet (ePIL) websites alongside physical cards to provide updatable information, which is a recommended approach.

Economic Operator Obligations in Detail

The MDR defines four categories of economic operators — manufacturers, Authorized Representatives, importers, and distributors — each with specific, legally binding obligations. This is a significant expansion from the MDD, which focused primarily on manufacturers.

Importer Obligations (Article 13)

Importers are entities that first place a device from a non-EU manufacturer onto the EU market. Their obligations include:

• Verify that the device bears the CE marking and that the EU Declaration of Conformity has been drawn up
• Verify that the manufacturer is identified and has appointed an Authorized Representative
• Verify that the device is labeled in accordance with the MDR and accompanied by required documentation (IFU, etc.)
• Verify that a UDI has been assigned where applicable
• Ensure storage and transport conditions comply with manufacturer specifications
• Maintain a register of complaints, non-conforming devices, and recalls
• Immediately inform the manufacturer and AR if they believe a device is non-conforming or presents a serious risk
• Cooperate with Competent Authorities on corrective actions
• Add their name, registered trade name or trademark, registered place of business, and contact information on the device or packaging (or accompanying document)

Distributor Obligations (Article 14)

Distributors make devices already on the EU market available for further distribution. Their obligations include:

• Verify (using representative sampling where appropriate) that the device bears CE marking, is accompanied by required information, and has a UDI where applicable
• Verify that the importer has complied with Article 13(3) for imported devices
• Ensure storage and transport conditions comply with manufacturer specifications
• Maintain a register of complaints, non-conforming devices, and recalls
• Immediately inform the manufacturer, AR, and importer if a device appears non-conforming
• Cooperate with Competent Authorities on corrective actions
• Not make a device available on the market if they believe it is non-conforming or presents a serious risk

Key Differences from MDD

Under the MDD, importers and distributors had minimal defined obligations. The MDR makes them active participants in the regulatory framework. This means:

• Importers and distributors must register in EUDAMED and obtain an SRN
• Both must cooperate with vigilance and market surveillance activities
• Community pharmacies, individual shops, and online retailers that sell medical devices are considered distributors and must comply with Article 14
• An EU-based distributor who obtains products directly from a non-EU manufacturer also assumes the role of importer under Article 13

MDCG 2021-27 Rev.1 provides detailed Q&A guidance on the practical implementation of Articles 13 and 14.

Annex XVI: Devices Without an Intended Medical Purpose

One of the MDR's most significant scope expansions is the inclusion of certain products without an intended medical purpose under Annex XVI. These are aesthetic or non-therapeutic products that are similar to medical devices in terms of functioning and risk profile, but for which the manufacturer claims only a non-medical purpose.

Products Covered by Annex XVI

1. Contact lenses or other items intended to be introduced into or onto the eye (e.g., colored contact lenses for cosmetic purposes)
2. Products for modifying anatomy — products intended to be introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts (excluding tattooing products and piercings)
3. Dermal fillers — substances or combinations of substances intended for facial or other dermal or mucous membrane filling by subcutaneous, submucous, or intradermal injection (excluding tattooing)
4. Liposuction equipment — equipment intended to reduce, remove, or destroy adipose tissue
5. Light-emitting equipment — high-intensity electromagnetic radiation emitting equipment (lasers, intense pulsed light) intended for skin resurfacing, tattoo or hair removal, or other skin treatment
6. Brain stimulation equipment — equipment intended for brain stimulation that applies electrical currents or magnetic/electromagnetic fields that penetrate the cranium

Regulatory Requirements

Annex XVI devices are subject to nearly all the same MDR requirements as medical devices, with specific adaptations documented in Commission Implementing Regulation (EU) 2022/2346 (Common Specifications) and Commission Implementing Regulation (EU) 2022/2347 (reclassification of certain active products). Key differences:

• Clinical evaluation needs to demonstrate safety and performance but not clinical benefit (since these devices have no medical purpose)
• Certain active devices have been reclassified: high-intensity electromagnetic radiation equipment for skin treatment is Class IIb (or Class IIa if intended only for hair removal); brain stimulation devices that penetrate the cranium are Class III
• There is no "grandfathering" — existing products on the market cannot rely on prior certifications and must go through full MDR conformity assessment
• MDCG 2023-5 provides guidance on qualification and classification of Annex XVI products

The date of application for Annex XVI devices began when the Common Specifications were published (December 2022), with transitional provisions set out in Implementing Regulation (EU) 2023/1194.

Practical Challenges Manufacturers Face

1. Clinical Evidence Gaps

Many legacy devices were originally placed on the EU market with limited clinical data — sometimes based solely on literature review and equivalence claims. Under the MDR, demonstrating equivalence requires a contract with the equivalent device manufacturer granting access to technical documentation, which is rarely achievable when the equivalent device belongs to a competitor. This leaves many manufacturers needing to generate original clinical data through clinical investigations — an expensive, time-consuming process.

2. Notified Body Bottleneck

As discussed above, Notified Body capacity remains the most significant systemic challenge. Manufacturers with large portfolios face the compounding problem of needing multiple assessments across different device groups, each with its own technical documentation review.

3. Legacy Device Transition

Transitioning a legacy portfolio of hundreds or thousands of devices from MDD to MDR certification is a multi-year program. Many manufacturers are forced to make difficult decisions about portfolio rationalization — discontinuing lower-revenue devices that do not justify the MDR certification investment.

4. GSPR Documentation Burden

The level of documentation specificity required by the MDR — particularly the GSPR checklist, the clinical evaluation report, and the PMS system documentation — far exceeds what was required under the MDD. Manufacturers who treated regulatory documentation as a one-time filing are finding that the MDR requires a living, continuously updated documentation system.

5. Supply Chain Complexity

The MDR imposes obligations on importers and distributors — not just manufacturers. Importers must verify that the manufacturer has complied with registration obligations, that the device bears a UDI, and that the manufacturer has appointed an AR. This has created new compliance burdens throughout the supply chain and, in some cases, disrupted existing distribution arrangements.

6. Software and Digital Health

Software classification under Rule 11, MDSW (Medical Device Software) qualification questions, cybersecurity requirements, and the evolving interplay between the MDR and the EU AI Act create a particularly complex landscape for digital health companies. Many software products that were unregulated or Class I under the MDD are now Class IIa or higher.

7. IVDR Performance Evaluation

IVD manufacturers are grappling with the IVDR's performance evaluation requirements, which are far more detailed than the IVDD's. The requirement for scientific validity, analytical performance, and clinical performance evidence — documented in a structured performance evaluation report — is new territory for many IVD companies, especially smaller ones that historically self-certified.

8. Disproportionate Impact on SMEs

Small and medium-sized enterprises (SMEs) — which make up the vast majority of Europe's approximately 38,000 medical device companies — are disproportionately affected by the MDR/IVDR transition. The challenges include:

• Cost burden: MedTech Europe's 2024 survey found that roughly half of respondents reported costs for clinical evaluation, PMS, and technical documentation assessment had more than doubled under MDR/IVDR. For SMEs with limited product portfolios, the cost of a single MDR certification (which can exceed €300,000 for the first year) may exceed the annual revenue generated by the device.
• Resource constraints: SMEs typically lack dedicated regulatory affairs teams. The complexity of MDR requirements — GSPR mapping, clinical evaluation reports, PMS systems, UDI implementation, EUDAMED registration — requires expertise that smaller companies often must outsource at significant cost.
• Notified Body access: Notified Bodies often prioritize larger clients with bigger portfolios. SMEs report difficulty securing NB capacity and face longer wait times.
• Portfolio rationalization: Many SMEs are being forced to withdraw niche or lower-revenue devices from the EU market because the cost of MDR certification cannot be justified by sales volume. The European Association of Pediatrics has documented cases where conformity assessment costs for a single pediatric device exceeded €800,000 — over 150 times the cost of obtaining FDA clearance for the same device.

A 2023 Boston Consulting Group survey of 104 senior medical device executives found that 89% of MedTech companies now plan to prioritize FDA approval over CE marking. The EU has fallen behind Japan and China as a priority market for 23% of CE-marked companies, with respondents overwhelmingly citing MDR rules as "complex and unpredictable."

9. Market Withdrawals and Device Availability

The MDR transition has led to real-world device withdrawals and shortages:

• Portfolio rationalization: A 2024 MedTech Europe survey found that 54% of respondents intend to remove devices currently CE-marked under the directives from the EU market. Companies are making deliberate commercial decisions to discontinue devices where the MDR certification cost outweighs the European revenue.
• Named examples: Reuters reported in 2022 that companies including Swedish medtech giant Getinge were either withdrawing from the EU market or discontinuing specific device lines due to MDR compliance costs. Multiple companies have followed since.
• Pediatric and orphan devices: Devices used in small patient populations — pediatric devices, rare disease devices — are at particular risk because the clinical evidence requirements of the MDR may be impossible or prohibitively expensive to meet for devices with limited clinical use data. MDCG 2024-10 guidance on orphan medical devices has attempted to address this, but the fundamental cost-evidence tension remains.
• IVD shortages: The IVDR transition, with its dramatic up-classification requiring Notified Body involvement for 80% of IVDs (up from 20% under IVDD), has raised genuine concerns about diagnostic device availability. Some manufacturers have already withdrawn lower-margin IVD products.
• European doctors' groups have reported equipment shortages directly attributable to the MDR transition, and the European Commission's own targeted evaluation acknowledged that the regulations are affecting device availability and the competitiveness of EU manufacturers.

The broader picture: The MDR is not "killing" the European medical device market — but it is reshaping it. Manufacturers are making rational economic decisions about which markets to prioritize and which products to sustain. The net effect is a contraction of the device portfolio available in Europe, particularly for niche, pediatric, and orphan devices. This is a patient access issue that regulators are now actively trying to address through the proposed MDR/IVDR simplification.

Harmonized Standards and Common Specifications

The MDR and IVDR reference harmonized European standards (hENs) and common specifications (CSs) as tools for demonstrating compliance with the GSPR.

Key Harmonized Standards

Standard	Scope
EN ISO 13485:2016	Quality management systems
EN ISO 14971:2019 + A11:2021	Risk management
EN 62366-1:2015 + A1:2020	Usability engineering
EN ISO 10993 series	Biological evaluation of medical devices
EN ISO 14155:2020 + A1:2024	Clinical investigations
EN 60601-1 series	Medical electrical equipment — safety and essential performance
EN 62304:2006 + A1:2015	Medical device software — lifecycle processes
EN ISO 15223-1	Symbols to be used with information to be supplied by the manufacturer
EN ISO 20417:2021	Information to be supplied by the manufacturer
EN ISO 11135 / EN ISO 11137 / EN ISO 11607	Sterilization and packaging

The Standards Gap

A persistent challenge is that not all standards have been harmonized under the MDR. Harmonization requires formal citation in the Official Journal of the EU, and this process has been slow. Some standards that were harmonized under the MDD have not yet been harmonized under the MDR. Manufacturers can still use these standards as evidence of compliance, but they cannot claim a presumption of conformity — the evidence must stand on its own.

Common specifications (CSs) are another tool. The European Commission can adopt CSs where harmonized standards do not exist or are insufficient. CSs have been published for specific device groups, including devices made from substances of animal origin and breast implants.

IVDR Common Specifications

Common Specifications are particularly important for the IVDR because they provide the detailed technical requirements for higher-risk IVDs. The key IVDR Common Specifications to date:

• Commission Implementing Regulation (EU) 2022/1107 — Common Specifications for Class D IVDs, covering: detection of blood group antigens (ABO, Rh, Kell, Duffy, Kidd systems), detection/quantification of markers for HIV, HTLV, HCV, HBV, CMV infections, detection of variant CJD markers, and related device groups
• Proposed amendments (August 2024) — The Commission published a draft amendment to (EU) 2022/1107 to add new Common Specifications for additional Class D device categories, with a public feedback period that closed in September 2024

For IVD manufacturers, Common Specifications function as a mandatory compliance benchmark. Under IVDR Article 9(3), if a manufacturer does not follow the applicable Common Specifications, it must justify the alternative approach used to achieve at least an equivalent level of safety and performance — and the Notified Body will scrutinize this justification closely.

MDR Annex XVI Common Specifications

For devices without an intended medical purpose (Annex XVI), Common Specifications are the regulatory trigger:

• Commission Implementing Regulation (EU) 2022/2346 — Common Specifications for all six Annex XVI product groups, covering risk management requirements, safety requirements, and information for safety (labeling and IFU)
• Commission Implementing Regulation (EU) 2022/2347 — Reclassification rules for certain active products without an intended medical purpose
• Commission Implementing Regulation (EU) 2023/1194 — Transitional provisions for Annex XVI devices

Well-Established Technology (WET) Devices

In early 2026, the European Commission adopted two delegated acts expanding the lists of devices classified as Well-Established Technologies (WET) under the MDR:

• C(2026) 1809 — Expanded the list of devices benefiting from simplified conformity assessment requirements (Notified Body reviews technical documentation for only one representative device per generic device group, rather than for each individual device)
• C(2026) 1798 — Expanded the list of devices exempt from the obligation to perform clinical investigations under Article 61(6)(b), allowing clinical evaluation based on existing data for implantable and Class III devices with a long safety track record

The expanded WET lists now include dental implants, braces, crowns, fillings, fixation devices (screws, wedges, plates, wires, pins, clips), bone wax, bone fillers, bone substitutes, suture-related items, and various other categories. This expansion is a significant relief for manufacturers of these well-established device types, potentially speeding market access and reducing costs without compromising safety.

Standards Gap: Current Status

As of early 2026, 277 standards have been requested under the MDR and 49 under the IVDR. The harmonization process — which requires formal citation in the Official Journal of the EU — remains slow. In January 2026, the European Commission implemented two new harmonization decisions covering clinical investigation/evaluation standards, neurosurgical implants, non-active surgical implants, and sterilization standards. However, significant gaps remain, and manufacturers should track the European Commission's harmonized standards work list for updates.

Conformity Assessment Costs: What to Expect

While costs vary significantly by device type, classification, and manufacturer size, the general trend is clear: MDR conformity assessment is substantially more expensive than MDD.

Cost Component	MDD (Typical)	MDR (Typical)
Initial Notified Body assessment	€15,000–€50,000	€40,000–€150,000+
Annual surveillance audit	€5,000–€15,000	€15,000–€40,000
Technical documentation review (per device/group)	Often included in QMS audit	€10,000–€60,000+ (separate, detailed review)
Clinical evaluation-related costs	Moderate (literature-based often sufficient)	High (original clinical data often required)
Total first-year cost (mid-complexity device)	€30,000–€80,000	€80,000–€300,000+

These figures are illustrative and vary widely. For large manufacturers with diversified portfolios, the total MDR transition cost can run into the tens of millions of euros across a full portfolio. MedTech Europe's 2024 survey confirmed that for roughly half of respondents, EU technical documentation assessment costs have at least doubled compared to MDD, and post-market surveillance costs have increased even more dramatically.

For startups and SMEs, the cost increase can be existential — and has been cited as a factor in companies exiting the European market. The European Association of Pediatrics has documented a case where one company received conformity assessment invoices exceeding €800,000 for a single pediatric device that already had 5 years of market access — more than 150 times the cost of obtaining clearance for the same device in the United States.

Additional cost factors that manufacturers often underestimate:

• Translation costs: Marketing devices across the EU can require labeling and IFU translations in up to 24 languages, each of which must be validated
• UDI implementation: Assigning UDI-DIs, integrating UDI into labeling systems, and registering in EUDAMED requires IT system changes and process updates
• Clinical investigation costs: Where original clinical data is required (especially for Class III and implantable devices where equivalence cannot be demonstrated), a European clinical investigation can cost €500,000 to several million euros depending on scope
• Ongoing compliance: Annual surveillance audits, PSUR preparation, PMS system maintenance, EUDAMED data updates, and PMCF activities represent recurring costs that many manufacturers did not face under the MDD

Cost context: The European Commission's December 2025 simplification proposal estimates that its proposed measures could bring annual cost savings exceeding €3 billion across the industry. This figure gives an indication of the current compliance cost burden the MDR/IVDR framework imposes.

Practical Recommendations

For Manufacturers Starting the MDR/IVDR Journey

1. Classify correctly first. Use the Annex VIII rules carefully, consider boundary cases, and validate your classification with your Notified Body or a qualified regulatory consultant.

2. Secure Notified Body capacity immediately. If you have not yet engaged a Notified Body, this is your highest-priority action. Review the NANDO database for designated bodies with scope matching your devices.

3. Invest in your clinical evaluation. This is where most manufacturers underestimate the effort. A robust clinical evaluation report compliant with MEDDEV 2.7/1 Rev. 4 (or the MDR equivalent guidance) requires systematic literature review, appraisal of clinical data, and clear justification of the benefit-risk determination.

4. Build a living QMS documentation system. The MDR requires documentation that is current, traceable, and integrated. Static, paper-based systems from the MDD era will not survive MDR conformity assessment.

5. Implement UDI early. Assign UDI-DIs through an accredited issuing entity (GS1, HIBCC, ICCBBA, or IFA), integrate UDI into your labeling processes, and prepare for EUDAMED registration.

6. Establish PMS infrastructure from day one. Do not treat post-market surveillance as a phase-four activity. Your PMS plan, PMCF plan, and vigilance reporting procedures must be in place before you submit for conformity assessment.

For Manufacturers Transitioning from MDD/IVDD

1. Conduct a comprehensive gap analysis between your existing MDD/IVDD technical documentation and MDR/IVDR requirements. Focus on clinical evidence, GSPR mapping, and PMS.

2. Prioritize your portfolio. Not every legacy device justifies the investment of MDR/IVDR transition. Make deliberate decisions about which devices to transition, which to redesign, and which to discontinue.

3. Update your clinical evaluation reports. MDD-era CERs are almost always insufficient for MDR. Plan for a complete rewrite that meets current expectations for systematic literature review, data appraisal, and equivalence justification.

4. Plan for simultaneous compliance. During the transition period, you may be maintaining MDD certificates for some devices and MDR certificates for others. Ensure your QMS can manage both.

5. Monitor regulatory developments closely. The MDR and IVDR implementation is still evolving. Guidance documents, MDCG guidance, and corrigenda continue to be published. Subscribe to European Commission and Competent Authority notifications.

6. Prepare for EUDAMED. With four modules becoming mandatory on May 28, 2026, ensure your Actor registration is complete, your SRN is obtained, and your UDI/device data is validated and ready for upload. For legacy devices, the registration deadline is November 28, 2026.

7. Implement Article 10a processes. Establish internal procedures to assess whether any anticipated supply interruption or discontinuation could result in serious harm. Build the six-month advance notification into your supply chain planning and discontinuation workflows.

Article 120: Understanding the Transitional Provisions in Detail

Article 120 of the MDR — titled "Transitional Provisions" — is arguably the most operationally critical section of the entire regulation for manufacturers of legacy devices. It defines the conditions under which MDD/AIMDD-certified devices can continue to be placed on the EU market during the transition to MDR. Understanding its nuances is essential for maintaining market access.

Key Concepts

Legacy devices are devices that were CE-marked under the MDD or AIMDD and continue to be placed on the market after the MDR date of application (May 26, 2021) under the transitional provisions. They benefit from extended transition periods if they meet all the conditions set out in Article 120(3c).

Old devices are devices that were lawfully placed on the market under the directives before the MDR date of application but are no longer being actively placed on the market. They may continue to be made available (distributed, sold from existing stock) until the applicable sell-off deadline.

Substitute devices are devices intended to replace a legacy device. The technical documentation may be submitted to the Notified Body at a later stage, but the manufacturer must identify both the substitute and the legacy device it is intended to replace.

What MDR Requirements Apply to Legacy Devices?

Even while operating under legacy MDD/AIMDD certificates, manufacturers of legacy devices must comply with certain MDR requirements. Per MDCG 2021-6 Rev.1 guidance, these include:

• Post-market surveillance (Articles 83-86): full MDR PMS requirements
• Vigilance reporting (Articles 87-92): MDR vigilance requirements replace directive requirements
• Registration of economic operators and devices (Articles 29-31): MDR registration requirements apply
• PRRC (Article 15): manufacturers must have a PRRC, though the timing obligation has been subject to guidance clarification
• Article 10a supply notifications: apply to legacy devices per Article 120(13)

However, the following MDR requirements do not apply to legacy devices during the transition:

• Full MDR technical documentation requirements (legacy devices maintain directive-format documentation)
• MDR UDI labeling obligations (though EUDAMED registration is required)
• MDR clinical evaluation requirements (legacy devices maintain directive-era clinical evaluations, though these should be updated as part of PMS)

Conditions That Can Invalidate Transitional Protection

A legacy device loses its transitional protection and can no longer be placed on the market if:

• The manufacturer makes a significant change to the device's design or intended purpose (per MDCG 2020-3 Rev.1 guidance)
• The manufacturer fails to maintain compliance with the applicable directive
• The manufacturer did not apply to a Notified Body by May 26, 2024
• A written agreement with a Notified Body was not signed by September 26, 2024
• The device presents an unacceptable risk to health or safety
• The manufacturer's QMS does not comply with MDR requirements

Practical tip: Manufacturers should maintain a documented rationale for each legacy device, demonstrating that all Article 120 conditions are met. This should be treated as a living document, updated as circumstances change, and ready for review by Competent Authorities at any time.

Article 10a: Supply Interruption Notification Obligations

Regulation (EU) 2024/1860 introduced Article 10a into both the MDR and IVDR, creating a new obligation effective from January 10, 2025. This requirement reflects the EU's growing concern about medical device shortages triggered by the MDR/IVDR transition.

What Article 10a Requires

Where a manufacturer anticipates an interruption or discontinuation of the supply of a device (other than a custom-made device), and where it is reasonably foreseeable that this could result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer must:

1. Notify the Competent Authority of the Member State where the manufacturer (or its AR) is established
2. Notify economic operators, health institutions, and healthcare professionals to whom the manufacturer directly supplies the device
3. Provide notification at least six months before the anticipated interruption or discontinuation (except in exceptional circumstances, where notification must be made "without undue delay")
4. Specify the reasons for the interruption or discontinuation

Scope

Article 10a applies broadly:

• To all devices placed on the EU market, regardless of classification
• To both MDR/IVDR-certified devices and legacy devices (per Article 120(13) MDR and Article 110(11) IVDR)
• To interruptions caused by any reason — regulatory (loss of certification, NB delays), manufacturing, supply chain, or commercial (voluntary discontinuation)

Notified economic operators must, in turn, relay the communication to the downstream supply chain.

What It Does Not Require

Manufacturers are not required to report:

• Interruptions or discontinuations anticipated before January 10, 2025, even if the actual interruption occurs after that date
• Supply issues for custom-made devices
• Situations where the interruption would not reasonably cause serious harm to patients or public health

The European Commission published a detailed Q&A document in December 2024 providing practical guidance, and MedTech Europe, AESGP, and COCIR jointly published a decision guide flowchart in March 2025 to help manufacturers implement structured decision-making processes.

Key MDCG Guidance Documents

The Medical Device Coordination Group (MDCG) — composed of representatives from all EU Member States and chaired by the European Commission — has published extensive guidance on the interpretation and implementation of the MDR and IVDR. These documents are not legally binding, but they represent the consensus view of regulators and carry significant weight with Notified Bodies and Competent Authorities.

Essential MDCG Guidance (Selected)

Reference	Title	Topic Area
MDCG 2025-10	Guidance on post-market surveillance of medical devices and IVDs	PMS
MDCG 2025-9	Guidance on Breakthrough Devices (BtX) under MDR and IVDR	Innovation
MDCG 2025-6	FAQ on interplay between MDR/IVDR and the AI Act	AI/Software
MDCG 2025-5	Q&A on performance studies for IVDs	IVDR
MDCG 2025-4	Guidance on safe making available of MDSW apps on online platforms	Software
MDCG 2024-14 Rev.1	Guidance on Master UDI-DI for contact lenses	UDI
MDCG 2024-10	Guidance on clinical evaluation of orphan medical devices	Clinical
MDCG 2024-1	Device Specific Vigilance Guidance (DSVG) template	Vigilance
MDCG 2023-5	Guidance on qualification and classification of Annex XVI products	Classification
MDCG 2022-7	Q&A on UDI system under MDR and IVDR	UDI
MDCG 2022-2	Guidance on general principles of clinical evidence for IVDs	IVDR Clinical
MDCG 2021-27 Rev.1	Q&A on Articles 13 and 14 (importers and distributors)	Economic Operators
MDCG 2021-6 Rev.1	Regulation (EU) 2017/745 — application of MDR requirements to legacy devices	Transition
MDCG 2020-16 Rev.4	Guidance on classification of IVDs	IVDR Classification
MDCG 2020-3 Rev.1	Guidance on significant changes for legacy devices	Transition
MDCG 2019-8 v2	Guidance on implant card (Article 18)	Implant Card
MDCG 2019-5	Registration of legacy devices in EUDAMED	EUDAMED

The complete list of MDCG guidance documents is maintained on the European Commission's Medical Devices Sector website and should be checked regularly. New guidance is published on a rolling basis — in 2025 alone, the MDCG published guidance on PMS, breakthrough devices, AI Act interplay, MDSW apps, IVD performance studies, and UDI implementation.

The MDR/IVDR and the EU AI Act

The interplay between the MDR/IVDR and the EU Artificial Intelligence Act (Regulation (EU) 2024/1689) is an increasingly important compliance consideration for manufacturers of AI-enabled medical devices and IVD software.

Dual Regulatory Framework

Medical Device AI (MDAI) — AI systems that are medical devices or components of medical devices — must comply with both the MDR/IVDR and, where applicable, the AI Act. The AI Act entered into force in 2024, with most obligations for high-risk AI systems applying from August 2, 2026, and full enforcement beginning in August 2027.

However, the regulatory interaction is nuanced. Under the AI Act's Article 6(1), AI systems that are part of medical devices are not classified as high-risk AI systems until August 2, 2027. This means that until that date, MDAI products are subject primarily to MDR/IVDR requirements, not the separate AI Act high-risk requirements.

MDCG 2025-6: Practical Guidance

In June 2025, the MDCG and the Artificial Intelligence Board (AIB) jointly published MDCG 2025-6 / AIB 2025-1 — an FAQ-style guidance document addressing the most common questions about dual compliance. Key clarifications include:

• Lifecycle management: Both the MDR/IVDR and AI Act require manufacturers to manage the entire lifecycle of MDAI, ensuring the device remains safe and performant throughout use
• Conformity assessment: For medical devices that are also high-risk AI systems, the MDR/IVDR conformity assessment (involving the Notified Body) will serve as the primary pathway, with AI Act requirements integrated rather than duplicated
• Quality management systems: The QMS requirements of the MDR/IVDR and AI Act overlap significantly; manufacturers can use a single integrated QMS to address both
• Classification: Annex XVI devices (without intended medical purpose) that are classified as Class I under MDCG guidance are not considered high-risk AI systems under the AI Act

The December 2025 Simplification Proposal and AI

The Commission's MDR/IVDR reform proposal (COM(2025) 1023) includes provisions specifically addressing AI-enabled medical devices, aiming to provide regulatory clarity and avoid duplicative requirements between the MDR/IVDR and AI Act frameworks.

Breakthrough Devices (BtX) Framework

In December 2025, the MDCG published MDCG 2025-9 — guidance introducing a structured EU framework for Breakthrough Medical Devices and In Vitro Diagnostic Devices (BtX) under the MDR and IVDR.

The BtX framework is designed to support innovative devices that address unmet medical needs or offer significant clinical advantages over existing treatments. The guidance establishes criteria for BtX designation and outlines how manufacturers, Notified Bodies, and Competent Authorities should interact to facilitate timely access to breakthrough technologies while maintaining safety standards.

A pilot program to implement the BtX guidance is expected to launch in Q2 2026. This represents the EU's first formal structured pathway for accelerating innovative medical device access — addressing a long-standing criticism that the MDR/IVDR framework lacks a fast-track mechanism comparable to the FDA's Breakthrough Devices Program.

Proposed MDR/IVDR Simplification (COM(2025) 1023)

On December 16, 2025, the European Commission published its long-anticipated proposal to amend the MDR and IVDR — COM(2025) 1023. This is the most significant proposed reform of EU medical device regulation since the original adoption of the MDR and IVDR in 2017. The proposal was published as part of the Commission's broader Health Package.

Why the Commission Is Proposing Changes

The Commission's targeted evaluation identified systemic problems:

• Certification bottlenecks and Notified Body capacity constraints
• Disproportionate compliance costs, particularly for SMEs
• Reduced device availability and innovation delays
• Inconsistent interpretation across Member States
• Overly burdensome administrative requirements that do not proportionally improve safety

The evaluation found that these issues are affecting device availability, weakening the competitiveness of EU manufacturers (particularly micro, small, and medium-sized companies), and hindering innovation — with a negative impact on healthcare quality and patient safety.

Key Proposed Changes

Simplified conformity assessment:

• Remove the fixed five-year certificate validity period — replace with risk-based periodic reviews by Notified Bodies
• Allow Notified Bodies to conduct remote audits (not only on-site) and reduce audit frequency to every two years where justified
• Reduce unannounced audits to "for cause" only (currently required at least every five years)
• For Well-Established Technology (WET) devices, NB reviews technical documentation for only one representative device per generic device group

PRRC simplification:

• Remove detailed qualification requirements for the PRRC
• For SMEs using external PRRCs, relax the "permanently and continuously available" requirement to simply "available"

Clinical evaluation:

• Allow more proportionate clinical evaluation for legacy devices with at least 10 years of robust clinical evidence and a low-risk profile, based on real-world evidence and PMCF data
• Narrow the scope of the Clinical Evaluation Consultation Procedure (scrutiny procedure) to cases where it provides clear added value

Post-market surveillance and vigilance:

• Reduce PSUR frequency for Class IIb/III devices from annual to first year only, then every two years
• Extend serious incident reporting deadline from 15 to 30 days (except for death, serious public health threats, or serious deterioration)
• Reduce NB PSUR review requirements for well-established technologies

Classification changes:

• Proposed reclassification of certain device categories to better reflect actual risk profiles

SME support:

• At least 50% fee reduction for micro-sized manufacturers and orphan devices
• At least 25% fee reduction for small enterprises
• Payment deferral options for micro and small enterprises until conformity assessment is finalized
• Requirement for Notified Bodies to treat micro, small, and medium-sized manufacturers equally to larger organizations
• Notified Bodies must respond to conformity assessment requests within 15 days

International reliance:

• Introduction of mechanisms for regulatory cooperation with trusted international jurisdictions

Labeling modernization:

• Expansion of electronic Instructions for Use (eIFU) provisions
• Simplified labeling requirements in certain areas

Estimated Impact

The Commission estimates that the combined simplification measures will bring annual cost savings exceeding €3 billion across the medical device industry, alongside improved legal certainty, coherence, and innovation-friendliness.

Current Status

The proposal is now before the European Parliament and Council under the ordinary legislative procedure. A public feedback period ran from January to March 2026. It is anticipated that 2026 will be a key year for legislative progress, with the Irish Presidency of the Council of the EU (second half of 2026) expected to prioritize this file. However, the MDR and IVDR have not yet been amended — all current requirements and transition deadlines remain in full force until any amending regulation is formally adopted and enters into force.

Strategic advice: Do not slow your MDR/IVDR compliance programs in anticipation of the proposed simplification. The legislative process will take time (likely 2027-2028 before any changes enter into force), and all current deadlines remain binding. However, do track the proposal closely — the direction of travel (proportionate oversight, risk-based reviews, SME support, longer certificate validity) will shape the regulatory landscape for the next decade. Companies that understand the proposed changes can make better strategic decisions about portfolio planning, clinical evidence strategy, and Notified Body relationships.

UK Market Considerations: CE Marking and UKCA

While this guide focuses on the EU market, manufacturers should be aware of the evolving UK regulatory landscape:

• Post-Brexit, the UK introduced UKCA marking, with transitional measures allowing CE-marked devices until June 2030
• As of early 2026, approximately 90% of devices on the GB market remain CE-marked, as many manufacturers have deferred UKCA transition
• The MHRA launched a consultation in early 2026 on three proposals: (1) extending GB transitional arrangements for MDD-compliant devices to align with EU timelines (until December 31, 2028), (2) indefinitely recognizing CE-marked devices compliant with EU MDR/IVDR, and (3) introducing an international reliance route for devices with higher UK classification
• The outcome of this consultation will determine whether manufacturers need separate UKCA conformity assessment or can rely on EU MDR/IVDR compliance for the GB market

For manufacturers operating in both markets, the potential for indefinite CE recognition in the UK would significantly reduce the dual compliance burden.

Looking Ahead

The MDR and IVDR represent a generational shift in European medical device regulation. The transition has been more difficult than the European Commission anticipated when the regulations were adopted in 2017. Notified Body capacity constraints, EUDAMED delays, the sheer scope of documentation requirements, and the resulting impact on device availability have tested every part of the system.

But the regulatory landscape is now at an inflection point. The December 2025 simplification proposal signals that the Commission has acknowledged the framework's structural problems and is moving toward solutions. The Breakthrough Devices (BtX) pathway, WET device expansions, and EUDAMED's mandatory go-live represent a maturing system — one that is becoming more operational and, potentially, more proportionate.

The direction is clear. Europe is building a regulatory system with stronger pre-market controls, comprehensive traceability, continuous post-market surveillance, and greater transparency. The proposed reforms aim to achieve this without the disproportionate burden that has driven device withdrawals and market exits.

For manufacturers, the next two to three years (2026-2028) will be the most demanding period in the entire MDR/IVDR transition:

• The final transition deadlines arrive (December 2027 for high-risk MDR devices, December 2028 for medium-risk)
• EUDAMED becomes a fully mandatory operational tool
• The IVDR transition continues with Class C (December 2028) and Class B (December 2029) deadlines
• The simplification proposal works its way through the legislative process
• The AI Act begins to apply to medical devices (from August 2027)
• Re-certification cycles begin for devices already certified under MDR/IVDR

Manufacturers who invest in robust quality management systems, thorough clinical evidence, and proactive post-market surveillance are positioning themselves not just for European compliance but for regulatory success globally — because the MDR's requirements are increasingly aligned with expectations in other major markets.

The manufacturers who will thrive are those that treat the MDR and IVDR not as a compliance burden to minimize, but as a framework that drives better devices, better evidence, and better outcomes for patients.