Clinical evaluation & investigation in Europe MDR

Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.

Link to colorcoded MS Word document with EU MDR 2017/745 excerpts that include “clinical investigation” or “clinical evaluation” in the text.

Ask any medical device regulatory consultant and they will tell you:
The European medical device clinical sky is falling!

Why? (you ask)
Because Europe actually wants us to prove our devices work in people via “clinical investigation” or “clinical evaluation”.

There is hardly a consultant in the world who does not like to count words in regulations to help make their fanatical point:
You need to hire me to help you deal with these words!

So let’s get to it. Here are my non-validated counts* for clinical-related terms in REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices.

316 clinical investigation
135 clinical evaluation (not counting “pre-clinical evaluation”)
40 PMCF (post market clinical follow-up)
31 clinical data
18 pre-clinical
17 clinical evidence
10 clinical practice
8 clinical performance
8 pre-clinical evaluation
6 non-clinical
5 clinical follow-up
4 clinical development
3 clinical procedure
3 clinical trial
2 clinical experience
1 clinical investigator
1 clinical assistance

*Caveat: My word processing software has not been validated (by me) for counting words.

And the winners are…(definitions below are from the EU MDR)…

CLINICAL INVESTIGATION: Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

CLINICAL EVALUATION: A systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

Link to colorcoded MS Word document with EU MDR 2017/745 excerpts that include “clinical investigation” or “clinical evaluation” in the text.

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.

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