Proposed Changes to EU MDR: What Manufacturers Need to Know

The European Commission has proposed a series of updates to the EU Medical Device Regulation (MDR) aimed at improving efficiency, reducing burden, and addressing long-standing bottlenecks—particularly around Notified Body capacity, classification clarity, and clinical requirements.

While the proposal is still moving through the legislative process, several themes are emerging: risk alignment, administrative streamlining, and selective flexibility.

Below is a breakdown of the most relevant developments for manufacturers and CER teams.

1. Certificates: Moving Away from the Fixed 5-Year Cycle

What’s Changing

• No automatic 5-year expiration for MDR certificates.

• Notified Bodies (NBs) may set certificate validity periods.

• Manufacturers may request extensions where justified.

• Legacy orphan devices may remain on the market beyond current MDR transition deadlines.

Impact

This introduces flexibility into the certification model and may reduce unnecessary recertification cycles for stable devices. However, manufacturers should expect more individualized NB determinations regarding certificate duration.

2. Notified Body Oversight and Operational Changes

Structured Dialogue Framework

• A formalized framework for structured dialogue between manufacturers and NBs.

• Intended to improve predictability and reduce late-stage review surprises.

Audit Model Adjustments

• Increased use of remote audits.

• Surveillance audits every two years where justified due to absence of safety issues.

• Limited unannounced audits.

• Under these changes, manufacturers holding ISO 13485 certificates will  largely maintain similar audit cadence.

Fees and Timelines

• Fee reductions for micro and small enterprises.

• 50% fee reduction for conformity assessment of orphan devices.

• Shorter NB review timelines are proposed.

• Some pushback from NBs regarding feasibility and resourcing.

Strategic Implication

Expect more procedural clarity—but not necessarily reduced scrutiny. Operational readiness and documentation completeness remain critical.

3. Accelerated Pathways and Vigilance Changes

• Accelerated pathways for breakthrough and orphan devices.

• Serious incident reporting timeline extended from 15 to 30 days.

The extended reporting window provides limited operational relief but does not reduce vigilance obligations. Robust PMS systems remain essential.

4. Software Classification: A Risk-Aligned Approach

Software will default to Class I unless:

• Class III: Intended for critical situations with risk of death or irreversible deterioration.

• Class IIb: Intended for serious situations involving serious deterioration or surgical intervention, or driving clinical management in critical situations.

• Class IIa: Intended for non-serious situations or to inform clinical management in serious/critical contexts.

Interpretation

This proposal does not radically overhaul classification but aims to better align classification with clinical risk and intended use. Further technical clarification is still under development.

Additionally:

• Accessories for implantable devices will no longer automatically be Class III and may be classified lower.

5. Documentation Requirements: Reduced Administrative Burden

SSCP (Summary of Safety and Clinical Performance)

• Required only for devices subject to full technical documentation assessment.

• No separate NB validation step.

• No separate “patient SSCP” requirement—only user-focused documentation (even if the user is a patient).

PSUR (Periodic Safety Update Report)

• Reduced reporting frequency.

These updates should ease recurring documentation burden, particularly for lower-risk portfolios.

6. AI Act Alignment with MDR

To avoid dual conformity assessments:

• Relevant elements of the EU AI Act may be incorporated into MDR.

• NBs assessing high-risk AI systems must demonstrate specific AI competencies.

Strategic Consideration

Manufacturers developing AI-enabled devices should prepare for heightened scrutiny around algorithm validation, training data, and performance monitoring—even if administrative duplication is reduced.

7. Clinical & Regulatory Strategy Changes

Well-Established Technology (WET)

• Expanded definition.

• Broader alignment with MDCG 2020-6.

• No clinical investigation required for Class IIa implantables or WET devices (under defined conditions).

Equivalence Adjustments

• Biological category: Same or similar materials/substances.

• Clinical category: Same or similar clinical conditions or intended purpose.

• Article 61(10) scope expanded (moderately).

In Silico Data

• Increased recognition of patient simulations and computer modeling.

GSPR 17.4 Updated

Manufacturers must still define:

• Minimum hardware requirements

• IT network characteristics

• IT security measures

• Protection against unauthorized access

In addition, manufacturers must set out minimum requirements for cybersecurity.

Single-Use vs Multi-Use

Devices will default to multi-use classification; manufacturers must justify single-use designation.

8. Timeline and Legislative Outlook

• Public feedback period: January 7 – May 8, 2026

• Final adoption: mid to late 2026

• NB timeline updates may begin as early as summer 2026Practical changes likely occurring 2027–2028.

• Manufacturers should assume a multi-year transition horizon.

9. Practical Advice for Manufacturers

Do Not Overcorrect Too Early

The legislative process remains iterative. Premature implementation of draft provisions may create rework.

Continue Business as Usual

• Maintain robust clinical data generation.

• Continue CER updates under current requirements.

• Complete submissions based on existing MDR expectations.

• Avoid delaying market access decisions in anticipation of reform.

The overarching message from regulators: Stay the course.

Conclusion

The proposed MDR revisions reflect a maturing regulatory framework—moving from rigid implementation toward targeted flexibility and risk alignment.

However, the fundamentals remain unchanged:

• Sufficient clinical evidence is still required.

• Documentation must remain audit-ready.

• Post-market surveillance remains central.

• Regulatory strategy must be forward-looking.

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