Clinical Evaluation, the Role of the EU NB

Clinical evaluation is a topic, which needs more attention according to the European Commission. 

This means more focus by manufacturers and Notified Bodies on clinical evaluations.

There is also more scrutiny on the Notified Bodies by the EU commission to follow the latest regulatory requirements on clinical evaluations when auditing manufacturers and reviewing product dossiers. 

The MEDDEV 2.7.1, rev. 4 guidance document about clinical evaluations was published in 2016, and requires serious attention by the manufacturers. 

Important topics in this presentation are:
  • the highlights of the MEDDEV 2.7.1 rev. 4
  • the focus of the Notified Body on clinical evaluations 
  • what are new clinical requirements for manufacturer in the MDR compared to MEDDEV 2.7.1, rev. 4
  • Alignment between Notified Bodies regarding clinical evaluations regarding the interpretations of the MDR requirements.