Why Switching Notified Bodies During MDR Transition Is Harder Than You Think

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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I see this scenario more often than I should. A manufacturer decides to switch Notified Bodies during the MDR transition, expecting a smooth handover. The assumption is that if the clinical evaluation already passed one review, another Notified Body will simply accept it and move forward.

That assumption is wrong.

The MDR transition created pressure on Notified Body capacity, but it also revealed something deeper: not all Notified Bodies evaluate clinical evidence the same way. When you switch, you do not just change the administrative counterpart. You change the lens through which your entire technical file will be reviewed.

This post explains why switching Notified Bodies during MDR transition is more complex than it appears, what triggers the real delays, and what you need to prepare before you make that decision.

The Regulatory Context: Why Switching Happens

Under the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD), many manufacturers worked with Notified Bodies that lost their MDR designation. Others found their Notified Body unable to handle the volume of recertification work. Some faced communication breakdowns or disagreements over clinical evaluation requirements.

Article 56 of MDR 2017/745 allows manufacturers to transfer certification to another designated Notified Body. On paper, this seems straightforward. In practice, it introduces a full reset of the review process.

The new Notified Body does not inherit the previous assessment. They start from their own risk evaluation. They apply their own interpretation of clinical sufficiency. They have their own internal procedures for equivalence, literature reviews, and PMCF.

And they are not required to accept what the previous Notified Body accepted.

What Actually Happens When You Switch

The first surprise comes during the kick-off meeting. The new Notified Body requests access to the full technical documentation. You provide the clinical evaluation report, the risk management file, the post-market surveillance plan.

Then comes the list of questions.

They challenge the equivalence claim that the previous Notified Body accepted without issue. They request additional literature that was never mentioned before. They ask for clarity on endpoints that seemed obvious in the original CER. They want a gap analysis between your PMCF plan and the latest MDCG 2020-8 guidance.

This is not obstruction. This is how Notified Bodies operate under MDR. Each organization has its own internal assessment protocols. Some focus heavily on clinical data robustness. Others emphasize post-market evidence. Some are strict on literature appraisal methodology. Others prioritize risk-benefit documentation.

When you switch, you lose the alignment you built with the previous Notified Body. You start over with a new reviewer who has no context, no history, and no obligation to follow the reasoning of their predecessor.

The Clinical Evaluation Becomes the Bottleneck

In most cases, the clinical evaluation report is where the switch creates the longest delay. The new Notified Body does not just skim the CER. They read it as if it is the first submission.

If your equivalence claim relies on a predicate device that is not well-known in their portfolio, they will scrutinize it. If your literature search strategy does not align with their expectations, they will request a revised appraisal. If your SOTA lacks depth in emerging risks, they will ask for updates.

I have worked on transfers where the new Notified Body requested a complete rewrite of the CER, not because the original was non-compliant, but because the structure and depth did not meet their internal standards.

This is the reality. The MDR gives Notified Bodies the authority to request what they need to reach a conformity decision. And when they are unfamiliar with your device, they request more.

The Hidden Costs of Switching

The most visible cost is time. What you thought would take three months can stretch to nine or twelve. Every round of questions adds weeks. Every revision adds review cycles. Every gap in the technical file adds delays.

But time is not the only cost.

You lose the institutional knowledge that existed with the previous Notified Body. If they were familiar with your device class, your technology, and your clinical strategy, that familiarity is gone. The new Notified Body starts from zero.

You also lose continuity in post-market surveillance. If the previous Notified Body was already reviewing your periodic safety update reports (PSURs) and had context on trending complaints, that context does not transfer. The new Notified Body will need to rebuild that understanding.

And you face the risk of conflicting interpretations. If the previous Notified Body accepted a certain clinical data package, but the new one does not, you are forced to generate additional evidence. This can mean new clinical investigations, new literature reviews, or new post-market studies.

That is not a theoretical risk. I have seen it happen on Class IIb and Class III devices where the predicate equivalence was challenged during the switch, forcing the manufacturer to conduct a clinical investigation they never planned for.

When Switching Makes Sense

Not all switches are avoidable. Sometimes the decision is forced by the loss of MDR designation. Sometimes the relationship with the current Notified Body is broken beyond repair. Sometimes the workload or communication delays make it impossible to meet timelines.

In those cases, switching is necessary. But it should be treated as a high-risk decision, not a simple administrative step.

If you must switch, the key is preparation. You need to understand what the new Notified Body expects before you submit. You need to know how they interpret equivalence, how they appraise literature, and how they evaluate PMCF plans. You need to have your clinical evaluation updated to the latest MDCG guidance, not just compliant with what the previous Notified Body accepted.

The manufacturers who succeed in switching are the ones who treat it as a new certification process, not a continuation of the old one.

What You Should Do Before You Decide to Switch

First, evaluate whether switching is truly necessary. If the issue is communication, try to resolve it internally first. If the issue is capacity, ask your current Notified Body for a realistic timeline. Switching will not always be faster.

Second, conduct a gap analysis of your clinical evaluation against the latest MDCG guidance. Do not rely on what was accepted before. Update your CER to reflect MDCG 2020-13, ensure your PMCF plan aligns with MDCG 2020-8, and verify that your SOTA is comprehensive.

Third, engage the new Notified Body early. Request a pre-submission meeting. Discuss your device, your clinical strategy, and your equivalence claims. Ask specific questions about their expectations. This will give you a preview of what is coming.

Fourth, budget time and resources. Assume the new Notified Body will request at least one full round of major questions on the CER. Assume you will need to revise the technical file. Plan for six to twelve months, not three.

Finally, communicate internally. Your executive team needs to understand that switching is not a shortcut. It is a risk management decision with significant implications for timelines and evidence generation.

What Happens If the Switch Fails

This is the question no one wants to ask, but it is worth considering. What if the new Notified Body ultimately decides they cannot certify your device under the current evidence package?

This happens. Not often, but it happens. The new Notified Body may determine that the clinical data is insufficient, that the equivalence claim does not hold, or that the risk-benefit profile is not adequately demonstrated.

In that scenario, you face a difficult choice. You can generate the additional evidence they request, which may mean a clinical investigation and additional years of work. Or you can seek another Notified Body, which resets the process again.

Neither option is fast. And by that point, you may have lost market access under the previous MDD certificate without a valid MDR certificate in place.

This is why switching during the transition is high-risk. The stakes are not just timeline delays. The stakes are market access.

Final Thoughts

Switching Notified Bodies during the MDR transition is not inherently impossible. But it is not simple either. It requires a full reset of the conformity assessment process, and it exposes your clinical evaluation to a new set of standards and expectations.

The manufacturers who navigate this successfully are the ones who prepare in advance, update their clinical evaluation to the highest standard, and treat the switch as a new certification process rather than a continuation of the old one.

If you are considering a switch, or if you are already in the middle of one, the most important thing you can do is ensure your clinical evaluation report is robust, current, and aligned with the latest MDCG guidance. That is the foundation that will determine whether the switch succeeds or becomes a prolonged regulatory challenge.

And if you are not switching, take this as a reminder: your relationship with your Notified Body matters. The alignment you build, the communication you maintain, and the trust you establish are not just administrative conveniences. They are strategic assets that protect your market access.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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