Get our free email newsletter

EU Commission revises standards list for medical device directive

The Commission of the European Union (EU) has issued a revised and updated list of standards that can be used to demonstrate conformity with the essential requirements its Directive 93/42/EEC concerning medical devices.

The Directive defines a ‘medical device’ as “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application….to be used for human beings for the purpose of: 1) diagnosis, prevention, monitoring, treatment or alleviation of disease; 2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; 3) investigation, replacement or modification of the anatomy or of a physiological process; or 4) control of conception.”

The revised list of CEN and Cenelec standards replaces all previously published standards lists for the Directive, and was published in July 2010 in the Official Journal of the European Union.

- Partner Content -

Fundamentals of Electrical Safety Testing

This white paper explores the evolution and critical role of advanced hipot testers in ensuring product safety. It details how modern testers perform dielectric withstand, insulation resistance, and ground bond tests, complying with global standards like IEC and UL. The paper emphasizes the necessity of reliable, accurate testing in manufacturing and certification processes.

View the revised list of standards for the EU’s Medical Device Directive.

 

 

Related Articles

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, and check out trending engineering news.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, and trending engineering news.

Close the CTA