Article 61(10) Is Not a Shortcut — It Is a Higher Burden of Justification

The new Team-NB position paper on clinical evaluation based on non-clinical data under MDR Article 61(10) lands on a topic that too many manufacturers still treat as a workaround.

That is the wrong mindset.

My view is simple: Article 61(10) is not an escape hatch from clinical evidence. It is a narrow, highly demanding justification route that forces manufacturers to prove, with unusual clarity, why clinical data is not necessary in the specific case.

And that distinction matters.

For years, some organisations have approached Article 61(10) as if it were mainly a documentation strategy — a way to build a file that explains why bench testing, preclinical evidence, standards, and technical verification should be enough. But the regulatory logic is tougher than that. The real question is not whether a manufacturer prefers a non-clinical route. The real question is whether the device characteristics, intended purpose, risk profile, interaction with the body, and existing state of the art genuinely support that route.

That is where Team-NB’s position matters. Even from the OCR-visible structure alone, the paper is clearly organised around manufacturer justification, what the Notified Body looks for, and common deficiencies. That is exactly the right frame — and also the real warning.

If you want to avoid clinical data under Article 61(10), your justification has to become more rigorous, more device-specific, and more defensible — not more convenient.

The direction of travel is clear

The paper reinforces something experienced regulatory teams already feel in practice: Notified Bodies are no longer impressed by generic claims that a device is well understood or low risk. They want structured reasoning, traceable evidence, and a justification that survives technical and clinical scrutiny.

In other words, saying “we do not need clinical data” is easy. Proving it under MDR is not.

If a manufacturer wants to rely on Article 61(10), the burden is not merely to assemble non-clinical reports. The burden is to show that those reports collectively answer the same core regulatory concern that clinical evidence would normally address: is the device safe, does it perform as intended, and is its use acceptable in the real clinical context?

What this means in practice

From a practical standpoint, Article 61(10) should force manufacturers to confront uncomfortable questions early:

• Are we truly arguing from device characteristics and scientific logic, or are we mostly trying to avoid the cost and effort of clinical evidence?
• Does our non-clinical package actually close the safety and performance questions, or does it only describe technical compliance?
• Can we explain our reasoning in a way that a Notified Body would find clinically credible, not just technically neat?
• Have we addressed the intended purpose, user population, mode of action, residual risks, and clinical context with enough depth?

That is where many files weaken. A polished technical dossier can still fail if the clinical evaluation reads like a defensive essay rather than a rigorous justification.

The real problem: confusion between testing and evidence

One of the biggest mistakes manufacturers make is assuming that a large amount of testing automatically equals sufficient clinical justification.

It does not.

Bench testing, biocompatibility, software verification, electrical safety, usability work, and standards conformity are all important. But Article 61(10) is not satisfied by volume. It is satisfied by relevance.

The key question is whether the non-clinical evidence meaningfully addresses the clinical claims being made.

A file can be full of test reports and still fail because it does not convincingly bridge those reports to real-world safety and performance in the intended clinical setting.

Why this matters for leadership, not just regulatory authors

This is not only a regulatory writing issue. It is a strategic issue.

Choosing an Article 61(10) pathway changes evidence planning, development timelines, Notified Body interaction, submission risk, post-market argumentation, and resource allocation.

If leadership treats Article 61(10) as the lighter route, the organisation may build a programme on a false assumption. In reality, the route can become more fragile, because once the justification is weak, the whole clinical evaluation narrative starts to wobble.

That creates delays, deficiencies, rework, and avoidable friction with the Notified Body.

My point of view

Manufacturers should use Article 61(10) rarely, deliberately, and only when they can defend it with intellectual honesty.

Not because the regulation forbids non-clinical justification. But because the MDR has changed the regulatory climate. Under the MDR, clinical evaluation is no longer a compliance accessory. It is one of the central demonstrations of product legitimacy.

That means any argument for not using clinical data must be exceptionally strong. And frankly, that is how it should be.

If a device can safely and legitimately be justified without clinical data, the reasoning should be robust enough to survive hard scrutiny. If it cannot, the problem is not the Notified Body. The problem is that the evidence strategy was too optimistic from the start.

The smart takeaway for manufacturers

The smartest way to read the Team-NB paper is not as a warning only. It is as a design instruction.

If you are considering Article 61(10), build the justification as if a sceptical reviewer will test every weak assumption — because they will.

That means:

• start the clinical strategy early
• align regulatory, clinical, risk, and technical teams
• make the justification device-specific
• connect non-clinical evidence directly to clinical claims
• eliminate generic language
• pressure-test the rationale before submission

The manufacturers who do this well will not treat Article 61(10) as a shortcut. They will treat it as what it really is: a specialised evidentiary route that demands stronger reasoning, not less work.

Final thought

The most important message behind Team-NB’s position is this: if you want to avoid clinical data, your justification must become more disciplined, more explicit, and more defensible — not more convenient.

That is the real regulatory lesson of Article 61(10).