Monthly Archives: February 2017

Clinical Evaluation Reports

Clinical Evaluation Reports for Medical Devices and the new MEDDEV 2.7/1 (rev 4)

Need to create or update your Medical Device Clinical Evaluation Reports? Published in June 2016 by the European Commission, MEDDEV 2.7/1 ‘Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, the new guidance document is much more explicit on how to undertake a robust and systematic clinical evaluation, and how […]