|
|
By Muna Kebede and Matthias Fink, AKRA Team GmbH
The EU's Medical Device Regulation, which entered into force in 2021, introduced new requirements for clinical and post-market data for medical devices in Europe. As an additional level of scrutiny for specific devices, the Clinical Evaluation Consultation Procedure ensures that notified bodies correctly assess the clinical data. Let's look at what we can learn from the expert panel's first published scientific opinions.
|