European Medical Device Standards: 2019-02-02

Sane people use their Saturday mornings for household tasks, lawn-mowing or catching up on sleep. Not me! I have a weekly appointment with myself that I call “Standards Watch”.

Today, I decided to figure out what medical device standards are either under development or have been published by CEN, the European Committee for Standardization.

CEN has the following Technical Committees dedicated to medical device standards:

Committee Title
CEN/CLC/JTC 16 CEN/CENELEC Joint Technical Committee on Active Implantable Medical Devices
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
CEN/TC 140 In vitro diagnostic medical devices
CEN/TC 204 Sterilization of medical devices
CEN/TC 205 Non-active medical devices
CEN/TC 206 Biological and clinical evaluation of medical devices
CEN/TC 403 Aesthetic surgery and aesthetic non-surgical medical services

Of note, European standards that are particular to “electrotechnical” standards are the focus of another organization, CENELEC, the European Committee for Electrotechnical Standardization. Other than medical standards coming from CEN/CENELEC Joint Technical Committee CEN/CLC/JTC 16, CEN and CENELEC work is non-overlapping. 

WARNING: This blog post does not address standards solely published by CENELEC. If your medical devices are non-active non-software devices, then do not worry about CENELEC standards.

My focus today was to search standards that have been published or are in-progress under the authority of the CEN Committees listed above.

In less than 2 hours of messing around, I was able to prepare a compilation of CEN Medical Device Standards that is accurate as of today, 2019-02-02. It includes 200 standards that are Published and 82 standards currently included in a Work Programme (drafting activity – new or revised documents). The Work Programme includes a large log-jam of standards needed to support the new European Medical Devices Regulation.

How did I do this? It was not that easy! I will spare you all of the details, but it involves using the CEN Technical Committee search engine (search term: medical devices), exporting data to Excel, and then combining and manipulating many Excel worksheets.

Here it the fruit of my Saturday morning labor: 
CEN Medical Device Standards_2019-02-02 (Sam Lazzara compilation).xlsx
It is a native Excel file that you can download for personal use.

If you liked this post, you may like these other posts on my MDQC Blog:

ISO IEC EN Standards Hacks, Tips, Tricks

What standards apply to my medical device?

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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