European Commission Issues Q&A on Requirements for Notified Bodies

The European Commission’s Medical Device Coordination Group (MDCG) released a Q&A on requirements for notified bodies (NBs) under the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).

The eight-page guidance addresses concerns NBs may have about their organizational structure, when they can provide pre-certification services, their authority prior to notification and how to ensure compliance with impartiality requirements.

Individual EU member states inform the Commission and other member states that a body has been designated to conduct conformity assessments. NBs may not accept applications under the MDR/IDVR until a day after their notification is published on the online Nando (New Approach Notified and Designated Organizations) information system.

A notified body’s organizational structure may differ depending on the legal entity and organization it belongs to, the guidance says. Holding companies, for instance, may need to provide an organizational chart of their head office that describes the functional and managerial relationships.

Pre-certification services may not be rendered before the manufacturer files an application, such as for clinical data review or assessment of a quality management system. Such services must take place “under the scope of the application,” the guidance states.

Read the coordination group’s guidance here: www.fdanews.com/06-07-19-NotifiedBodies.pdf. — James Miessler