EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value

Determining how to provide adequate clinical evidence for CE marking under the EU’s Medical Device Regulation can be a tricky business. But legacy device manufacturers will take comfort knowing they are familiar with some elements of the latest guidance.

Merger (Onchira Wongsiri/Shutterstock.com) — How Part of Former Clinical guidance document is being embedded into new guidance

The European Commission’s Medical Device Coordination Group (MDCG) has issued a useful background note on the relationship between two key guidances relating to clinical evidence.

One of these documents was issued in 2020 in the context of the current Medical Device Regulation (MDR) and the...