New definition of “application observations”
What's new in 2025 on the topic of “application observations”?
On the pages of an ethics committee, applicants have recently found the category “application monitoring” under the categorization of their clinical trial for some interventional randomized controlled clinical trials involving medical devices.
This is new and applies to the Berlin Medical Association. Here, such studies that fall under §47 paragraph 3 MPDG - formerly §23b of the MPG - are referred to as: “Application monitoring in accordance with Section 47 paragraph 3 Medical Device Implementation Act (formerly §23b Medical Devices Act)”.
This is therefore contrary to the definition of the Working Group of Medical Ethics Commissions (AKEK), according to which: “Application observations are non-interventional studies in which the use of a medical device under everyday conditions is documented without the doctor being influenced by a predetermined test plan in his/her treatment decision. The decision to use the product is independent of participation in the study.”
We are excited to see how this will unravel!
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