EU MDR/IVDR releases Q&A for the Notified Bodies


The European Commission, on Thursday, released an 8 eight-paged answer to the 4 set of questions that clarifies the regulatory obligations with regards to Notified Bodies. The document covers "organizational and general requirements" along with resource and process requirements.

The major issues that were raised in the Q&A document, with organizational and general requirements, relate to the meaning of the terms “legal personality,” “organization” and “organizational structure” under MDR/IVDR, as well as the clearance of consultants per Regulation (EU) 920/2013. Another answer speaks to what industry continues to see as the most troublesome roadblock in the transitions to both MDR and IVDR.