Europe Clinical Evaluation Guidelines SmackDown

The European Commission’s medical device conniption reached a frenzied pitch with the release of the Medical Devices Regulation (MDR) 745/2017 in May 2017.

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Credit: Google (hyperlink)

The writing has been on the wall for awhile now. The Europe Clinical Evaluation guidelines were updated from Rev. 3 (2009) to Rev. 4 in 2016. The new guidelines – MEDDEV 2.7/1 Rev. 4 – foreshadowed the requirements of the European MDR.

To help with your own personal conniption and subsequent preparations, I have prepared a side-by-side comparison between the Rev. 4 and Rev. 3 documents. Here it is in MS Word format so you can use it for your own purposes.

May the clinical evaluation judges be kind (or at least fair) to you!

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.