MDCG 2019-6 Rev5 | MDCG Update on Requirements for Notified Bodies

The Medical Device Coordination Group (MDCG) has published Revision 5 of document MDCG 2019-6, which provides detailed answers to questions on the requirements for Notified Bodies under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). This update aims to clarify the obligations and responsibilities of Notified Bodies, ensuring regulatory compliance and promoting harmonisation within the European Union.

Main Changes and New Clarifications:

Revision 5 includes important updates, namely:

• Clarifications on the impartiality and independence of Notified Bodies, including rules to avoid conflicts of interest.

• Specifications for consulting and compliance with MDR and IVDR regulations.

• Detailed requirements on training and experience necessary for those involved in conformity assessment.

• Guidance on structured dialogue between Notified Bodies and manufacturers, promoting transparency without compromising impartiality.

• Criteria for substantial changes and frequency of surveillance audits to ensure ongoing compliance.

Impact on the Medical Device Industry:

This document is essential for Notified Bodies and medical device manufacturers who wish to maintain compliance with EU regulations. The changes aim not only to ensure transparency and impartiality in the certification process, but also to facilitate the harmonisation of requirements across the European Union.

For more information, please refer to the full MDCG 2019-6 document below.