Simplification Is Not Deregulation: What the MDR Reform Means for Your CER Strategy

If the five-year recertification disappears, does your Clinical Evaluation Report (CER) get easier? Many manufacturers are hoping so. We think that is the wrong bet.

The proposed reform changes when and how notified bodies check your evidence. It does not remove the need for that evidence. The safest plan is to move from a CER you rebuild before an audit to a CER you keep current all year.

What was said about the MDR reform at RAPS Convergence?

On 16 September 2026, RAPS reported on a Convergence panel with speakers from the European Commission, a notified body and industry law. The panel reviewed the state of play of the European Commission's proposed changes to the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746).

A Commission official said the goals are less administrative burden, more predictability and shorter processes, while keeping a high level of patient safety. Attorney Erik Vollebregt warned manufacturers not to confuse simplification with deregulation. In his words, the system will keep the same "regulatory philosophy", and the proposal does not lower evidence or safety requirements.

What exactly does the proposal change?

The Commission published its proposal on 16 December 2025 as COM(2025) 1023. You can follow it on the EUR-Lex procedure page and the Commission's medical devices page. It is still a proposal: the European Parliament and the Council must adopt it before anything changes.

According to the Council's copy of the proposal text, the changes most relevant to a CER include:

Topic	Today (MDR)	Proposed
Certificate validity	Certificates last up to five years (Article 56)	The five-year maximum is removed. Notified bodies carry out periodic reviews in proportion to device risk
Notified body contact	No explicit legal basis for pre-assessment dialogue	A legal basis for structured dialogue with the notified body (Annex VII)
Medium-risk devices	Technical documentation assessed under the Annex IX–XI routes	Less documentation assessed for medium-risk devices, based on sampling
What counts as clinical data	Defined in the MDR	Broader: includes published studies on the device that are not necessarily peer-reviewed
Equivalence	Contract for access to the other manufacturer's documentation	Contract requirement removed, conditions more flexible
Non-clinical evidence	Limited room to rely on it alone	More room, and explicit support for methods such as in silico testing
PMCF reporting	Separate PMCF evaluation report	PMCF findings can go straight into the updated CER

Read this table as a summary, not as legal text. Details may change during negotiations, and law firms summarising the same proposal do not always describe every point in the same way.

Does the CER go away, or get lighter?

The clinical evaluation stays. Nothing in the proposal removes the duty to show that your device is safe, performs as claimed and has an acceptable benefit-risk balance.

What changes is the mix of evidence you may use and the way you report it. Some of that may save effort. Some of it, such as flexible equivalence or non-clinical data, will need a stronger written justification, not a weaker one.

Why is "wait and see" a risky CER strategy?

Imagine a Class IIb manufacturer whose certificate expires in eighteen months. The team pauses CER work because "the rules might change." Then the reform is delayed, or adopted with a long transition, and the team has one quarter to rebuild years of literature and PMCF data.

Three reasons make waiting costly:

• The proposal is not law. Until it is adopted, Article 56 and the current rules apply.
• Continuous updating is already required. MDR Article 61(11) says the clinical evaluation must be updated throughout the device's life with PMS and PMCF data. The proposal does not remove that duty.
• Review does not stop. If recertification becomes periodic review, your notified body will still examine your evidence during the certificate's life. Weak spots are then more likely to surface as they arise than at a single renewal date.

Notified bodies also raised concerns at the panel. A TÜV SÜD representative argued for risk-adaptive surveillance, including unannounced audits and technical documentation sampling, and for access to EUDAMED data. That debate is still open, so do not assume that lighter oversight is coming.

What does a living, audit-ready CER look like?

A living CER is one where every claim can be traced to current evidence, and where new data flows in on a schedule. It means you do not need a special project before each audit.

Which practices should you set up now?

1. Fix your update triggers. Write down what forces a CER update: new PMS or PMCF data, complaints, field safety actions, new state-of-the-art literature, design changes.
2. Set a literature cadence. Run and document your literature searches on a fixed schedule, not only before an audit. Keep the search protocol stable so results are comparable.
3. Link CER, PMCF and PMS. Your PMCF plan, PMCF evaluation, PSUR and CER should reference each other. A finding in one should visibly change the others.
4. Keep a change log. Record what changed in each CER version, why, and who approved it. Notified bodies assess CERs with the MDCG 2020-13 template, and a clear trail makes that review easier.
5. Justify every evidence choice. If you rely on equivalence, non-clinical data or non-peer-reviewed studies, explain why the evidence is sufficient for your device and claims.
6. Prepare for structured dialogue. If it becomes law, you will get more from a meeting with your notified body if you arrive with a clear evidence map and open questions.

Where does AI-assisted drafting help?

Keeping a CER current is repetitive work: screening new papers, extracting data, comparing findings with the last version and rewriting affected sections. This is where AI assistance can help most.

In our view, AI is useful for:

• screening and summarising new literature against your search protocol,
• extracting data into structured tables,
• flagging which CER sections are affected by new data,
• producing first drafts of updates for expert review.

It does not replace the evaluator. The manufacturer stays responsible for the content, so qualified people must check sources, conclusions and the benefit-risk statement. Keep records of what was AI-assisted and how it was reviewed, so you can explain your process to an assessor.

Key takeaways

• The Commission's reform is a proposal. It is not yet law, and current MDR rules still apply.
• Removing the five-year cap would replace recertification with periodic risk-based review. It does not remove the evidence requirement.
• Some evidence rules may become more flexible, but flexibility will need clearer written justification.
• The practical goal is a CER that is updated continuously, with traceable links to PMS, PMCF and literature.
• AI can make regular updates sustainable, as long as expert review and documentation stay in place.

FAQ

Is the five-year recertification already gone?

No. It is part of a Commission proposal from December 2025 that Parliament and Council still have to adopt. Until then, certificates follow the current MDR.

Will we still need a CER if the reform passes?

Yes. The proposal changes parts of the clinical evaluation rules, such as what counts as clinical data and how PMCF is reported. It does not remove clinical evaluation.

Can we rely on non-clinical data alone under the new rules?

The proposal widens the room for this, and encourages methods such as in silico testing. How far it goes will depend on the final text and on guidance from regulators and notified bodies, so treat it as a case-by-case justification.

Should we pause CER updates until the reform is final?

We would not. Current rules require ongoing updates, and a CER that is already up to date will be ready under either version of the rules.

Can AI write our CER?

AI can speed up literature screening, data extraction and first drafts. A qualified evaluator must still review and approve the content, because the manufacturer remains responsible for it.

Want to build a CER that stays current without a rebuild before every audit? Contact the Qmedify Regulatory Team to talk through your plan.