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.
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.
