MDR Transition: What Most Teams Misunderstand About 2027

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

in
S

I review transition documentation almost daily now. The pattern is consistent. Teams focus on forms, timelines, and administrative checklists. They map old certificates to new MDR pathways. They plan submission windows.

Then they hit the clinical evaluation section.

That’s when they realize the gap isn’t about time. It’s about the quality and depth of clinical evidence that MDR requires compared to what existed under MDD or AIMDD. And that gap doesn’t close with project management. It closes with clinical work.

Understanding the Real Transition Challenge

The transition deadlines are clear. December 31, 2027 for Class IIb and III devices under Article 120(3). December 31, 2028 for Class I, IIa, and custom-made devices. These dates are fixed. They won’t move again.

But these deadlines only matter if your documentation is ready to submit when your slot with the Notified Body opens.

And here’s what most teams underestimate: Notified Bodies are not reviewing transition files the way they reviewed MDD files. The bar has moved. They apply full MDR requirements, even to devices with legacy certificates. That means a compliant clinical evaluation report under MDR Article 61 and Annex XIV. It means a state of the art analysis grounded in current literature. It means equivalent device claims that meet the strict criteria of MDR Annex XIV Section 3.

If your existing CER was written under MDD, it won’t pass MDR scrutiny. Not because the device changed. Because the standard changed.

The Clinical Evidence Gap

Under MDD, many CERs were built primarily on equivalence. You demonstrated that your device was equivalent to a predicate, and the predicate had clinical data. The chain could be indirect. The analysis could be brief.

MDR tightened equivalence dramatically. Annex XIV Section 3 now requires technical, biological, and clinical equivalence. The comparator must be in compliance with MDR. You must demonstrate equivalence across all characteristics that could influence safety and performance. And you must justify why differences don’t affect the clinical profile.

Most legacy equivalence claims don’t meet this standard.

So what happens during transition? Teams discover that their predicate device either no longer qualifies under MDR criteria, or the equivalence justification is insufficient. They try to patch it. They add comparisons. They rewrite sections.

But the real issue runs deeper. If equivalence fails, you need clinical data on your own device. And if you don’t have that data, you need to generate it. That takes time. PMCF studies, literature reviews, registry participation—all of this must be planned, executed, and documented.

You can’t compress that timeline to fit a regulatory deadline.

State of the Art and Clinical Context

Another gap that surfaces during transition: state of the art analysis. MDR Article 61(1) and Annex XIV require manufacturers to analyze current knowledge, including the state of the art. This isn’t a static section. It evolves as medical knowledge evolves.

Many legacy CERs lack this analysis entirely. Or they include a brief paragraph on clinical background without engaging with recent literature, alternative treatments, or emerging technologies.

During transition, Notified Bodies expect a full SOTA section. They want to see how your device compares to current treatment options. They want to understand the clinical context in which your device is used. They want evidence that you’ve reviewed recent publications and considered whether new risks or performance issues have emerged.

This work can’t be delegated to a literature search. It requires clinical judgment. It requires understanding what has changed in the field since your device was first cleared or approved. It requires synthesis.

If your team doesn’t have access to clinical expertise—either in-house or through external consultants—this section becomes a bottleneck.

PMCF and the Ongoing Evidence Requirement

MDR Article 61(11) and Annex XIV Part B make PMCF mandatory for most devices. It’s not optional. It’s not something you do if you feel like it. It’s a systematic requirement to collect and analyze post-market clinical data throughout the lifecycle of your device.

During transition, Notified Bodies review your PMCF plan. They check whether it’s implemented. They look at your PMCF reports and periodic safety update reports (PSURs). They assess whether you’re actively collecting data or just maintaining a placeholder plan.

I see transition files where the PMCF plan is generic, copied from a template, and never executed. No data collected. No analysis performed. No updates to the CER based on real-world use.

That’s a major deficiency. It signals that the manufacturer isn’t maintaining clinical evidence as required by MDR. It raises questions about whether post-market risks are being detected and addressed.

If your PMCF plan isn’t active, start now. You need real data, real analysis, and real integration into your CER before submission.

Notified Body Capacity and Queue Management

Everyone knows the Notified Body capacity issue. There aren’t enough auditors. The queues are long. Some Notified Bodies have stopped accepting new clients or limited their intake.

But what’s less discussed is how this affects transition strategy.

If you’re planning to submit in late 2026 or 2027, your Notified Body may already be fully booked. They’re managing their pipeline. They’re prioritizing existing clients. They’re balancing new certifications, surveillance audits, and transition files.

That means you need to communicate early. Confirm your slot. Understand their timeline. Ask what documentation they expect before they’ll schedule your review.

And here’s the critical part: if they reject your submission because your CER isn’t compliant, you go back into the queue. You don’t just resubmit the next week. You wait for the next available slot. That delay can push you past the deadline.

So the quality of your submission matters even more than usual. You can’t afford a rejection. You can’t afford a major non-conformity that requires resubmission.

This is why preparation can’t start in 2026. It needs to start now.

Strategic Considerations for Transition Planning

Here’s what I recommend to teams managing transition:

First, conduct a gap analysis of your current CER against full MDR requirements. Don’t assume compliance. Review it as if a Notified Body auditor is reading it for the first time. Check equivalence claims. Check SOTA. Check PMCF integration. Identify the gaps.

Second, prioritize devices. If you have multiple products transitioning, rank them by commercial importance, clinical risk, and documentation readiness. Focus resources on high-priority devices first. Accept that some lower-priority products may not transition.

Third, secure clinical expertise. Whether internal or external, you need someone who can perform the clinical analysis required by MDR. This isn’t a regulatory affairs task. It’s a clinical evaluation task.

Fourth, start PMCF data collection immediately if it’s not already active. Even if your device has been on the market for years, you need post-market clinical data under MDR. Design a plan, implement it, and document the results.

Fifth, engage your Notified Body early. Ask about their expectations. Ask about their timeline. Ask what they’re seeing in other transition files. This feedback can guide your preparation.

What Happens if You Miss the Deadline

If your certificate isn’t transitioned by the deadline, you lose your legal basis for placing the device on the EU market. The grace period is over. The old certificate is invalid.

You can’t sell the device. You can’t distribute it. Existing devices in the field remain under post-market surveillance, but you can’t supply new units.

Some manufacturers are planning to let certain products lapse. They’ve calculated that the cost of transition exceeds the commercial value of the product. That’s a business decision.

But for critical products, for high-revenue devices, for devices with no alternative on the market—missing the deadline isn’t an option.

And yet I see teams that are still delaying. Still assuming they have time. Still treating this as a future problem.

The future is now. The preparation window is closing.

The Real Question

The real question isn’t whether the deadlines will hold. They will. The Commission has been clear. The Notified Bodies have been clear.

The real question is whether your clinical evidence is ready.

Because the deadline is fixed, but the quality of your documentation determines whether you meet it. And quality takes time. It takes clinical work. It takes rigor.

Most teams have the timeline mapped. But they don’t yet have the evidence.

That’s the gap that determines whether your device transitions or not.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
Follow me for more insights and practical advice.