Commentary & Analysis - Compliance & Risks

EU Commission updates Standards lists for 3 Directives on Medical Devices.

Written by judith | Jan 24, 2013, 10:13:04 AM

The Commission of the European Union has published updated lists of Standards that can be used to demonstrate conformity with the essential requirements of the following 3 Directives concerning medical devices.

  1. Council Directive 90/385/EEC of 20 June 1990 relating to active implantable medical devices.
  2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
  3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.

The extensive list of CEN and Cenelec Standards was published on 24 January 2013 and replaces all previously published standards lists for the Directives.  For further information on this please contact us.