Get our free email newsletter

EU Commission Issues New Standards List for In Vitro Diagnostic Medical Devices Directive

The Commission of the European Union (EU) has published an updated list of standards that can be used to demonstrate compliance with the essential requirements of its Directive 98/79/EC, dealing with in-vitro diagnostic medical devices.

According to the EU’s Directive, an in-vitro diagnostic medical device is “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”

Under the Directive’s definition, specimen receptacles are considered to be in-vitro diagnostic medical devices, while products for general laboratory use are not, unless such products are intended to be used for in vitro-diagnostic examination.

- Partner Content -

How to Perform a Radiated Emissions Measurement

Radiated emissions testing is the measurement of the electromagnetic field of the emissions that are unintentionally being generated by the equipment under test.

The updated list of CEN and Cenelec standards that can be used to support compliance with the Directive was published in July 2015 in the Official Journal of the European Union, and replaces all previously published standards lists for the Directive.

View the updated standards list.

Photo by r.nial.bradshaw

Related Articles

Digital Sponsors

Become a Sponsor

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

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, trending engineering news, and weekly recall alerts.