EU MDR/IVDR Simplification 2026: Proposed Changes, Timeline & What Manufacturers Must Know

The Biggest Regulatory Overhaul Since MDR Came Into Force

On December 16, 2025, the European Commission published COM(2025) 1023 final — a legislative proposal to amend the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). This is not a minor technical adjustment. It is the most significant revision to the EU medical device framework since MDR replaced the old directives.

The proposal, known as the Simplification Package, aims to reduce administrative burden by approximately 30%, address Notified Body capacity constraints, prevent device shortages, and create faster pathways for innovative technologies. The Commission estimates the changes could deliver combined annual cost savings exceeding €3.3 billion. It responds to years of industry feedback, parliamentary resolutions, and the practical reality that MDR and IVDR have created bottlenecks that threaten patient access to medical devices across Europe.

This guide explains every major proposed change, the legislative timeline, and what manufacturers should do now to prepare.

Why This Proposal Exists

The European Commission's own evaluation of MDR and IVDR concluded that the current framework has led to:

• Unnecessary costs for manufacturers, particularly SMEs
• Administrative bottlenecks at Notified Bodies, with average certification review times of 13–18 months
• Regulatory uncertainty for companies trying to plan market access
• Delays in patient access to new medical technologies
• Risk of device shortages as thousands of legacy devices struggle to transition from the old MDD/IVDD directives

Industry groups including MedTech Europe, the European Parliament, and multiple Member States have called for reforms since 2024. The December 2025 proposal is the Commission's formal legislative response.

Where the Proposal Stands Now

Stage	Status	Timeline
Commission proposal published	Done (Dec 16, 2025)	—
Public feedback period	Closed (Jan 7 – Mar 5/18, 2026)	Completed
EESC opinion	Expected	April 2026
European Parliament position	Under development	Mid-2026
Council position	Under development	Mid-2026
Trilogue negotiations	Expected	Late 2026
Political agreement	Possible	Late 2026 – early 2027
Entry into force	Anticipated	2027 (at earliest)

The proposal must pass through the ordinary legislative procedure — approval by both the European Parliament and the Council. Adoption is anticipated by summer 2026 at the earliest, though realistically, the final text may not be adopted until late 2026 or early 2027. Changes to the text are expected during negotiations.

Critical point: The proposal is NOT yet law. Current MDR and IVDR rules remain fully in effect. Plan your 2026 compliance strategy based on existing regulations.

The Key Proposed Changes

1. New Software Classification Rule (Revised Rule 11)

This is arguably the most impactful change for digital health companies.

Current Rule 11: Nearly all standalone software (MDSW/SaMD) is classified as Class IIa or higher, requiring Notified Body involvement for conformity assessment.

Proposed Rule 11: Software intended to generate outputs for clinical benefit would default to Class I (self-declared conformity, no Notified Body required), with escalation to higher classes only when the software is used in serious or critical clinical situations.

Clinical Situation	Proposed Classification
Software providing general wellness or non-clinical outputs	Class I (no NB)
Software informing clinical decisions in non-serious conditions	Class I (no NB)
Software informing treatment of serious conditions	Class IIa
Software driving clinical management of critical conditions	Class IIb or III

The intent is to significantly reduce Notified Body workload for lower-risk software while maintaining strict oversight for software used in high-risk clinical scenarios.

However, the practical effect of the revised wording is debated. Some legal analyses suggest the escalation criteria may still capture a broad range of software, and the final text may change during legislative negotiations.

What to do now: Do not change your classification strategy based on the proposal. Current Rule 11 applies. But begin mapping which of your software products might qualify for Class I under the new rule, so you are ready to act if the amendment is adopted.

2. Indefinite Certificate Validity

Current rule: MDR/IVDR certificates are valid for a maximum of 5 years, after which manufacturers must undergo full recertification.

Proposed change: The five-year maximum is removed. Certificates would remain valid indefinitely unless the Notified Body identifies a justified, risk-based reason to limit validity.

Instead of recertification, Notified Bodies would conduct periodic reviews proportionate to device risk while the certificate remains valid. This eliminates the costly and resource-intensive cycle of full recertification every five years.

This change also addresses a major concern: the risk of mass market withdrawal if thousands of certificates expire simultaneously and Notified Bodies lack capacity to process renewals in time.

3. Breakthrough and Orphan Device Pathways

The proposal introduces two new regulatory pathways:

Breakthrough Devices

Devices qualify as breakthrough if they:

• Bring a high degree of novelty in technology or clinical application
• Deliver significant clinical benefits for life-threatening or severely debilitating conditions
• Either outperform existing options or meet an unmet medical need

Benefits include:

• Priority and rolling review by Notified Bodies
• Early scientific expert advice
• Conditional certification with post-market data requirements
• Faster EU market access

Orphan Devices

Devices targeting rare diseases or conditions affecting small patient populations would benefit from:

• Mandatory 50% fee reduction at Notified Bodies
• Legacy orphan devices certified under MDD/IVDD may continue to be marketed beyond current transitional deadlines
• Expert panel review every 10 years to confirm continued orphan status
• Relaxed requirements where full clinical data is impractical due to small patient populations

4. Regulatory Sandboxes

The proposal introduces regulatory sandboxes — controlled environments where manufacturers can test innovative devices under regulatory supervision of competent authorities, with temporary adaptation or waiver of certain MDR/IVDR requirements.

Key sandbox features:

• Set up by Member States, either on their own initiative or at manufacturer request
• Limited-time framework with a defined sandbox plan
• Allows development, testing, validation, and real-world use of innovative products
• May waive or adapt requirements from classification, conformity assessment, clinical evidence, or specific annexes
• Enables earlier EU market access while maintaining regulatory oversight

This is particularly relevant for AI-based medical devices and novel digital health technologies.

5. Fixed Conformity Assessment Timelines

For the first time in EU medical device regulation, the proposal would establish legally fixed timelines for conformity assessment:

Activity	Proposed Timeline
Notified Body initial review	60 calendar days
Certificate renewal issuance	15 calendar days
Structured dialogue response	Defined periods

This addresses one of the biggest complaints from manufacturers: unpredictable and excessively long review times. Notified Bodies are reportedly unhappy with the proposed timelines, arguing they may be unrealistic for complex devices, so this provision may change during negotiations.

6. Notified Body Reforms

The proposal includes several measures to increase Notified Body capacity and transparency:

• Mandatory fee publication — Notified Bodies must publicly disclose their fee schedules and notify the Commission for publication on a dedicated website
• Mandatory SME fee reductions — at least 50% reduction for micro-enterprises, at least 25% for SMEs, and 50% for orphan device assessments
• Deferred payment option — micro-enterprises and SMEs can defer Notified Body fees until the conformity assessment activity is completed
• Remote audits — Notified Bodies may replace on-site audits with remote audits where justified
• Reduced surveillance frequency — surveillance audits every two years (instead of annually) where no safety issues have been identified
• For-cause unannounced audits — unannounced audits should be conducted only when triggered by specific concerns, not randomly
• Structured dialogue — formal pre- and post-submission communication framework between manufacturers and Notified Bodies

7. Reduced Administrative Burden

Several provisions aim to cut paperwork:

Current Requirement	Proposed Change
Fixed 5-year certificate validity	Indefinite (unless risk-justified limitation)
PSURs on tight schedules	Extended PSUR update timelines
SSCP/SSP for all assessments	Required only for full technical documentation assessment
Paper EU Declaration of Conformity	Digital format permitted
Paper IFUs	Electronic IFUs (eIFUs) allowed for near-patient tests
Paper-based communications	All communications electronic via EUDAMED

8. Classification Changes

Beyond the software Rule 11 revision, the proposal adjusts classification for specific device types:

• Reusable surgical instruments — would receive lower risk classification
• Accessories to active implantable devices — would receive lower risk classification
• Certain software — default Class I with escalation criteria
• Repackaging and relabelling — removed requirement for Notified Body certificate and prior notification

These down-classifications would reduce Notified Body involvement for devices where the current MDR classification is considered disproportionate to the actual risk.

9. "Well-Established Technology" Devices

The proposal introduces a new category of "well-established technology" (WET) devices — long-established technologies with well-known safety and performance profiles. WET devices would benefit from:

• Exemption from the requirement to prepare a Summary of Safety and Clinical Performance (SSCP)
• Simplified conformity assessment procedures
• Assessment of technical documentation for one representative device per generic device group (rather than every variant)
• Regulatory derogations that reduce the documentation burden for proven technologies

This is particularly relevant for manufacturers of conventional devices with decades of clinical history that have been disproportionately burdened by MDR requirements designed for higher-risk, novel products.

10. Clinical Evidence Flexibility

The proposal expands the categories of acceptable clinical evidence, which is particularly relevant for legacy devices transitioning from MDD to MDR:

• Non-clinical data may be accepted in more circumstances
• Equivalent device data gets broader acceptance criteria
• Broader reliance on equivalence to demonstrate conformity
• New approach methodologies (including in silico testing) are promoted
• Legacy devices can leverage existing clinical experience more easily
• In-house IVD manufacturers no longer limited to cases where no suitable alternative exists on the market
• Hospital "homebrew" IVDs can be shared with other hospitals

11. PRRC Obligations Simplified

The Person Responsible for Regulatory Compliance (PRRC) requirements would be relaxed for smaller companies:

• Micro and small enterprises may use an external PRRC who needs to be "available" rather than "permanently and continuously" present
• This makes compliance more feasible for startups and small manufacturers

12. AI Device Provisions

The proposal addresses overlap between MDR/IVDR and the EU AI Act:

• MDR and IVDR would be moved from Section A to Section B of the AI Act, meaning AI-enabled medical devices would only need to comply with AI-related requirements set out in sectoral legislation (MDR/IVDR), not the full AI Act HRAIS requirements
• Only a limited number of AI Act provisions would apply to medical and IVD devices
• Notified Bodies for high-risk AI-enabled devices would still need to meet AI Act qualification requirements
• Procedures for AI-based medical devices would be simplified to avoid dual compliance burdens
• This change could significantly reduce the compliance burden for the healthcare sector, but it must survive the legislative process — the exclusion is not yet a fact

Relationship to EUDAMED Deadlines

The Simplification Proposal is separate from the EUDAMED mandatory use deadline. On November 27, 2025, the European Commission confirmed that four EUDAMED modules are fully functional, triggering a six-month transition period.

Starting May 28, 2026, the following EUDAMED modules become mandatory:

1. Actor registration — manufacturers, importers, authorized representatives
2. UDI/Device registration — device identification and registration
3. Notified Bodies and Certificates — certificate data
4. Market Surveillance — post-market surveillance data

This deadline is independent of the Simplification Proposal and will take effect regardless of whether the proposal is adopted.

Impact on Transition Deadlines

The existing MDR transition periods (extended under Regulation 2024/1860) remain in effect:

Device Class	MDR Transition Deadline
Class III and Class IIb implantable	December 31, 2027
Other Class IIb, Class IIa, and Class I (sterile/measuring/reusable)	December 31, 2028

The Simplification Proposal does not change these deadlines. However, the proposed indefinite certificate validity and legacy orphan device provisions would provide additional flexibility for manufacturers who obtain MDR certification within the transition window.

What This Means for Different Stakeholders

For SaMD/Digital Health Companies

The revised Rule 11 could dramatically reduce the cost and timeline for lower-risk software products. If your software only provides general clinical information without driving treatment decisions in serious conditions, you may qualify for Class I self-declaration. But this change is not yet law — continue with current Rule 11 classification.

For Established Device Manufacturers

Indefinite certificate validity eliminates the five-year recertification cycle. Fixed conformity assessment timelines provide predictable planning. Reduced PSUR frequency cuts ongoing compliance costs. Prepare to take advantage of these changes, but maintain current compliance efforts.

For SMEs and Startups

Mandatory Notified Body fee reductions (50% for micro-enterprises, 25% for SMEs), deferred payment options, and relaxed PRRC obligations make EU market access more affordable. Regulatory sandboxes offer a pathway for innovative products that might not fit traditional conformity assessment routes.

For IVD Manufacturers

In-house IVD rules are relaxed, clinical evidence requirements are broadened, and orphan device provisions support rare disease diagnostics. The IVDR transition timeline pressures remain, but the overall framework becomes more manageable.

What Manufacturers Should Do Now

1. Do not delay current compliance efforts — The proposal is not yet law. Current MDR/IVDR rules apply. Continue transition activities and Notified Body submissions on schedule.

2. Map the potential impact — Identify which proposed changes would affect your product portfolio. Which devices might be down-classified? Which software products could benefit from the new Rule 11? What would indefinite certificates mean for your renewal planning?

3. Engage in the legislative process — The public feedback period is closed, but industry associations and trade groups continue to influence the negotiations. Ensure your views are represented through relevant industry bodies.

4. Prepare for EUDAMED — The May 28, 2026 deadline for mandatory EUDAMED use is independent of the proposal and will happen regardless. Actor registration, UDI/device registration, and certificate data submission must be ready.

5. Build flexibility into your regulatory strategy — Plan for both scenarios: the proposal being adopted largely as-is, and it being significantly amended. Maintain current compliance while building optionality for the proposed changes.

6. Assess breakthrough/orphan eligibility — If you have devices targeting rare diseases or offering significant clinical advances for life-threatening conditions, begin documenting the evidence that would support breakthrough or orphan designation.

Proposed Changes Summary Table

Area	Current Rule	Proposed Change
Software classification	Class IIa+ (nearly always)	Default Class I, escalation by clinical severity
Certificate validity	Maximum 5 years	Indefinite (unless risk-justified limit)
NB review timeline	No fixed limit	60 days initial review
SME NB fees	No mandatory reduction	50% (micro), 25% (SME)
Remote audits	Limited	Explicitly permitted
Surveillance audits	Annual	Every 2 years (if no safety issues)
PSUR frequency	Fixed schedules	Extended timelines
EU DoC format	Paper	Digital permitted
Repackaging/relabelling	NB certificate required	NB certificate removed
Well-established technology	No special category	New WET designation with simplified conformity
In-house IVDs	Only if no market alternative	No "no alternative" restriction
PRRC (SMEs)	Permanently present	"Available" (external allowed)
Regulatory sandboxes	Not established	Formal sandbox framework
Breakthrough devices	No dedicated pathway	Priority review, conditional certification
Orphan devices	No dedicated pathway	Fee reduction, legacy grandfathering

Timeline: What to Expect

Dec 2025 ─── Proposal published
Jan-Mar 2026 ─── Public feedback period (closed)
Apr 2026 ─── EESC opinion expected
Mid 2026 ─── Parliament and Council develop positions
Late 2026 ─── Trilogue negotiations
Early 2027 ─── Possible political agreement
2027 ─── Entry into force (earliest realistic estimate)
2027-2028 ─── Implementation period

Between now and adoption, the text will be debated, amended, and renegotiated. Some provisions may be strengthened, others weakened or removed entirely. Manufacturers should treat this as a direction of travel, not a final destination.

Frequently Asked Questions

Is the Simplification Proposal already law?

No. It is a legislative proposal that must be approved by the European Parliament and the Council. It will likely be amended during negotiations. Current MDR/IVDR rules remain fully in effect.

When will the changes take effect?

Realistically, not before 2027. The legislative process — Parliament position, Council position, trilogue negotiations, formal adoption — takes time. The Commission hopes for adoption by summer 2026, but most observers expect late 2026 or early 2027.

Does this affect the May 2026 EUDAMED deadline?

No. The EUDAMED mandatory use date (May 28, 2026) is established under separate legislation (Regulation 2024/1860) and will proceed regardless of the Simplification Proposal.

Will my existing MDR certificate be affected?

No. Existing certificates remain valid under current rules. If the proposal is adopted, the indefinite validity provision would apply prospectively. The proposal focuses on simplification, not re-certification of existing devices.

Should I delay my Notified Body submission and wait for the new rules?

Absolutely not. The transition deadlines (December 2027 for Class III/IIb implantable, December 2028 for Class IIa/IIb/I) are fixed and independent of the Simplification Proposal. Waiting could result in your certificate lapsing before the new rules take effect.

How does this interact with the EU AI Act?

The proposal explicitly aims to simplify procedures for AI-based medical devices to avoid overlap with the EU AI Act. Details of the dual compliance framework will be developed during the legislative process and through subsequent implementing acts.

What about legacy devices still transitioning from MDD?

The proposal extends additional flexibility to legacy devices through broader clinical evidence acceptance and the orphan device grandfathering provisions. However, the existing transition deadlines under Regulation 2024/1860 remain in effect and should be your primary planning horizon.