Legislation for medical devices

Updated 02 January 2019

The following references identify the implementation of the European directives on medical devices into the Danish legislation.

Acts, Executive Orders and Circulars are available in Danish at retsinformation.dk

Acts

  • Act No. 1046 of 17 December 2002 concerning medical devices
  • Act No. 364 of 18 May 1994 - the Danish Product Safety Act

Executive Orders and EU Commission Regulations

  • The Ministry of Health's Executive Order No. 1263 of 15 December 2008 concerning medical devices
  • The Ministry of the Interior and Health's Executive Order No. 1269 of 12 December 2005 concerning in vitro diagnostic medical devices
  • The Ministry of Health's Executive Order No. 1264 of 15 December 2008 concerning active implantable medical devices
  • The Ministry of the Interior and Health's Executive Order No. 410 of 31 May 2004 concerning medical devices manufactured utilising tissues of animal origin
  • EU Commission Regulation No 722/2012 of 8 August 2012 with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
  • EU Commission Regulation No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices
  • The Ministry of Health's Executive Order No. 1546 of 18 December 2014 concerning fees for medical devices
  • The Ministry of Health's Executive Order No. 1460 of 18 December 2014 on fees for importers and distributors of medical devices
  • The Danish Medicines Agency's Executive Order No. 292 of 19 March 2010 concerning the application for the authorisation for clinical investigation of medical devices on human subjects
  • The Ministry of Economic and Business Affairs' Executive Order No. 1037 of 8 December 2003 concerning coordination of administration of the Danish Product Safety Act
  • The Ministry of Health's Executive Order No. 1155 of 22 October 2014 concerning commercials etc. for medical devices
  • The Ministry of Health's Executive Order No. 1748 of 21 December 2018 concerning fees on medical devices
  • The Ministry of Health's Executive Order No. 1749 of 21 December 2018 concerning fees for importers and distrubutors of medical devices

Circulars

  • The National Board of Health's Circular No. 15015 of 19 August 1968 concerning radiation sterilisation of medical utensils (disposable equipment) predominantly consisting of plastic.

Guidelines

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