We know very well what a significant change of (medical) devices is in the scope of the MDR since the publication of MDCG 2020-3 Rev1.

The use of clinical data of a "similar" medical device based on the principle of equivalence is highly problematic.

We present you with a summary of the newly published Q&A addressing the practical aspects of fulfilling the manufacturer's new obligation.

Amendments to EU regulations will be approved, mandating earlier Eudamed use. Gradual use starts Q4 2025, fully by Q4 2027.

“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g....