What is MDR Article 61(10)?

MDR Article 61(10) is a provision under EU MDR 2017/745 that allows manufacturers, in specific cases, to use non-clinical data instead of clinical data to demonstrate the safety and performance of a medical device during clinical evaluation.

When can manufacturers use non-clinical data under MDR Article 61(10)?

Manufacturers can use non-clinical data when they can scientifically justify that clinical data is not appropriate or necessary, and when device safety and performance can be adequately demonstrated through validated non-clinical methods such as bench testing, simulations, or animal studies.

Does MDR Article 61(10) apply to all medical devices?

No. Article 61(10) is generally intended for Class I, Class IIa, and certain Class IIb non-implantable medical devices. Devices with significant interaction with the human body or explicit clinical claims usually require clinical data.

What evidence is accepted for MDR Article 61(10) justification?

Accepted evidence may include bench testing, simulated use testing, animal studies, in vitro testing, computational modeling, performance evaluations, and compliance with recognized harmonized standards.

Can a Notified Body reject an MDR Article 61(10) justification?

Yes. A Notified Body may reject the justification if the manufacturer fails to demonstrate adequate risk control, relies on unsupported claims, ignores available clinical data for similar devices, or cannot prove that non-clinical evidence sufficiently establishes safety and performance.