The European Commission’s Medical Device Coordination Group has published a 17-page guidance document on IVD Regulation codes, MDCG 2021-14, to help notified bodies assign fully competent staff to the devices they are required to assess.
The guidance expands on Commission Implementing Regulation 2017/2185, which lists codes and the corresponding types of device for specifying notified body scopes under both the Medical Device Regulation and...