Updating or creating 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 to demonstrate the scientific validity of the data and conclusions (including new prescriptive Appendices).
Throughout the new MEDDEV, the links between clinical evaluations, risk management, post-market surveillance (PMS) and post-market clinical follow-up are reinforced.
Notified Bodies will certainly be looking more closely at how the essential requirements are met (including those regarding usability) as well as the concept of “equivalence”, if claimed – an equivalent device should be almost identical to the device undergoing clinical evaluation.
Q: How often does your clinical evaluation report (CER) need to be actively updated?
A: This frequency must be defined and justified. For products that pose a “significant risk” to the user / patient and are not well established this needs to be performed at least annually; in other cases, with a frequency of 2 to 5 years. And, of course, updates should be made whenever new information from the PMS affects the evaluation or its conclusions.
See more at Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 and 90/385
Kind regards,
Karen
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Karen Real
Director
Real Regulatory Ltd
London
United Kingdom
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