No Quick Fix When It Comes To EU Medtech Notified Body Designations

Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.

A figurine of a man contemplating walking up wooden steps — Steep 15-Step Process To Notified Body Designation • Source: Shutterstock

The European Commission’s Medical Device Coordination Group (MDCG) has updated its timelines chart to help the medtech sector better understand how long each stage of the notified body designation takes.

This information is particularly important given the exponential rise in demand for conformity assessment body (CAB) services under the Medical...