New MDCG Guidance documents released (September 2022)

On September 14th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This document provides guidance on the appropriate surveillance to be conducted by Notified Bodies for in vitro diagnostic medical devices covered by certificates issued under Directive 98/79/EC (MDCG 2022-15).

MDCG 2022-15 – Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD.

This guidance clarifies the elements to be verified by the notified bodies and allows manufacturers placing on the market devices covered by the IVDD certificates (legacy devices) since May 26th, 2022, to identify the topics that will be evaluated during surveillance audits (under the IVDD).

What does this mean to you?

MDCG 2022-15 clarifies the scope for notified bodies when they need to conduct surveillance audits for legacy devices under the IVDD and helps identifying manufacturers of those devices what the scope will be of such audit.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.