Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

What is suitable for Article 61 (10)?

It is not a route for devices where there is a lack of clinical data, it is for devices where clinical data is not appropriate. Devices qualifying under Article 61 (10) do not make clinical claims.

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Pre Clinical Data

High Quality Clinical Investigatio ns

The Grey Zone

The boundaries of MDR have been set!

What about those devices in-between?

• Class IIa/IIb devices where clinical trial data is not feasible? • Class III devices with no available data e.g. Accessories ?

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