The guidance document MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies has been updated. To offer some background to this document, initially released in 2019, this guidance document was released to provide a compilation of questions and answers regarding the requirements for notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The topics addressed have been identified through joint assessments, and the document may be periodically updated as new issues arise.
The latest changes to this document include the following:
- Questions I.5.1 and I.5.2 Added to replace I.5
- Questions I.6.1, I.6.2 and I.6.3 Added to replace I.6
- Question I.9. Updated
- Question IV.1. Updated
- Question IV.7. Updated
- Question IV.10. Updated
- Question IV.12. Update
- Question IV.13. New Q&A added
The updated guidance document can be accessed using the following link
