Article 61(10) of the MDR: Applying the clinical data exemption correctly
The Medical Device Regulation (MDR) equires a clinical evaluation for all medical devices. This is generally based on clinical data.Only in the cases set out in Article 61(10) may the clinical evidence, by way of exception, also be based on suitable non-clinical data.
As part of this evaluation, Intended Use and clinical benefit in the sense of a direct therapeutic effect. Many medical devices fulfil supportive, diagnostic or preventive functions and do not, in doing so, have a direct therapeutic effect. Nutzen-Risiko-Analyse is carried out. Notified bodies assess the evidence submitted in accordance with high scientific standards in order to obtain verifiable and robust conclusions regarding the safety and performance of the product.
Article 61 of the MDR defines when clinical evaluations and tests must be carried out, the scope they must have, and how this must be justified.
But what if the safety and effectiveness of a product could be fully demonstrated by suitable non-clinical data? This is where Article 61(10) of the MDR: an exception that manufacturer are permitted, under strict conditions, to rely on non-clinical data. The wording of the article is as follows:
“If demonstrating compliance with General Safety and Performance Requirements on the basis of clinical data is deemed inappropriate, any such exception […] must be adequately justified […].“
(EU MDR, Art. 61.10; as of May 4, 2026)
It follows that: Exemptions from the requirement to conduct clinical trials are, in principle, possible – but must be substantiated with valid reasons. Whilst the MDR sets out the framework for such exemptions, the precise scope of their application remains vague.
In order to clarify the scope of Article 61.10, the Team NB, the Association of Notified Bodies in the EU, now a postion paper published. It not only explains, when Article 61.10 applies, but also, how manufacturers must structure their reasoning in such a way that it stands up to scrutiny by the Notified Bodies.
When Does Article 61.10 Apply – And When Does It Not?
To begin with, the exemption can only be applied to devices in risk classes I, IIa and IIb. Class III devices and implantable devices are excluded from the outset.
Article 61.10 is a narrow exception and applies only where clinical data are objectively unsuitable for the assessment of safety and performance.
There are clear limits in this regard:
- Not just a quick fix: Arguments such as “Clinical data is difficult to obtain” will be categorically rejected. The exception is not intended to simplify matters, but is dictated by practical necessity.
- Clinical benefit does not, as a matter of principle, preclude the application of Article 61(10): A medical device may offer clinical benefit and still fall within the scope of this derogation. However, this applies only on condition that all relevant safety and performance parameters – including the benefit-risk ratio – can be reliably demonstrated by validated non-clinical methods. If clinical data are required for this purpose, Article 61(10) shall not apply.
Note: Every medical device has an intended use within the meaning of the MDR; however, not all products provide a clinical benefit in the sense of a direct therapeutic effect. Many medical devices fulfil supportive, diagnostic or preventive functions and do not, in doing so, have a direct therapeutic effect.
- Focus on non-clinical methods: The exception is only permitted where all relevant parameterscan be fully documented using non-clinical methods . (e.g. bench tests, simulations, material tests).
What Manufacturers Need to Bear in Mind
The justification for applying Article 61(10) must be comprehensive and transparent. Team NB’s position paper sets out the requirements in three steps:
1. State-Of-The-Art Analysis
- Comparison with similar products: Is there already clinical data available for comparable devices? If so, Article 61(10) does not generally apply.
- Definition of parameters: Can all safety and performance characteristics be verified using non-clinical methods? A detailed breakdown is required here
2. Detailed Justification
- Clinical role: How critical is the product to the expected overall benefit? The greater the relevance, the stricter the requirements for justification – a latex glove is easier to justify than an ECG electrode.
- Physical interaction: Invasiveness, duration of contact and tissue sensitivity must be assessed. Where the risk potential is high, the bar for non-clinical data is particularly high.
- Risk management: Are all residual risks covered by non-clinical tests? Unclear or unaddressed risks preclude the application of Article 61(10).
3. Changes to PMS Obligations
- No PMCF for the time being: Post-Market Clinical Follow-up (PMCF) is only partially compatible with the logic of Article 61(10). However, manufacturers must carry out comprehensive Post-Market Surveillance (PMS) and ensure vigilance. This includes literature reviews and the evaluation of user feedback in order to monitor long-term safety and performance and to demonstrate the continued applicability of Article 61(10).
The objective of the clinical evaluation remains unchanged. Article 61(10) does not alter the purpose of the clinical evaluation, but merely the permissible data basis.
The Team NB position paper also emphasises that there is no universally applicable list of products to which Article 61(10) applies. Decisions are always made on a case-by-case basis. The key factors here are, in particular, the intended purpose of the device, the relevant safety and performance parameters, and the current state of the art.
In conclusion, Article 61(10) is not a free pass, but a strictly regulated exception, the application of which is only possible with a comprehensive justification and full risk coverage. Manufacturers bear a correspondingly high burden of proof in this regard.
So Why Even Consider 61.10 at All?
Given all these restrictions and strict requirements, one might quite rightly ask whether it makes any sense at all to consider the exemption.
The answer depends on the context. If a product does not provide a clinical benefit – for example, because it forms part of a treatment unit or is a surgical instrument – the rationale for applying code 61.10 may be straightforward.
Furthermore, in this case, there are no costs associated with organising and conducting clinical trials – such savings are usually substantial.
In Team NB’s view, the existence of a clinical benefit argues against the applicability of Article 61.10, as the relevant performance characteristics can, in principle, be clinically validated.
It should be noted, however, that depending on the available evidence and comparability with other products, existing clinical trials may also be drawn upon.
Furthermore, the update to product group 31 by the German GKV shows that there are cases where entire product categories no longer require clinical tests. Please read our article on this subject.
Above all, Team NB’s position paper demonstrates that regulatory affairs is a field characterised by constant negotiation and dynamic development. Consequently, a case-by-case assessment, combined with drawing on experience and expert knowledge, remains the surest route to a smooth certification process.
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