Over 20 years servicing the medical device industry

MEDDEV 2.7.1 Rev 4 Clinical Evaluation A Guide for Manufacturers and Notified Bodies, released and effective from June 2016, is posing a difficulty for many medical device manufacturers. It requires a vastly different approach from the previous revision of the guidance in the generation and approval of the Clinical Evaluation Report.

We have written many CERs, which have been reviewed and accepted by many Notified Bodies and regulatory agencies outside Europe. We can assist you in yours also.