Legislation for medical devices

Medical device legislation

List of acts, executive orders, regulations and circulars applicable in Denmark. Titles of Danish legislation are translated to English for ease of understanding.

Danish acts

• Act no 682 of 29 May 2023 on medical devices
• Act no 799 of 09 June 2020 on products and market surveillance

Danish executive orders and European regulations

Medical devices and in vitro diagnostic medical devices

• Danish Ministry of Health’s executive order no 837 of 20 June 2023 on medical devices and in vitro diagnostic medical devices
• European regulation nr. 2017/745 of 5 April 2017 on medical devices (MDR)
• European regulation no 2017/746 on in vitro diagnostic medical devices (IVDR)

Electronic instructions

• European Commission regulation no 207/2012 of 9 March 2012 on electronic instructions for use of medical devices
• European Commission implementing regulation no 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices

Designation and supervision of notified bodies

• European Commission regulation no 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies

Fees

• Danish Ministry of Health’s executive order no 839 of 20 June 2023 on medical devices and in vitro diagnostic medical devices
• Danish Ministry of Health’s executive order no 840 of 20 June 2023 on fees for importers and distributors of medical devices and in vitro diagnostics medical devices

Advertising

• Danish Ministry of Health’s executive order no 715 of 24 May 2022 on advertising, etc. for medical devices

Hazardous substances in electrical and electronic equipment

• Danish Ministry of Environment’s executive order no 483 of 13 May 2024 on the restriction of the use of certain hazardous substances in electrical and electronic equipment in the EU

Guidelines 

Advertising

• Guideline no. 9469 of 25 June 2024 on advertising, etc. for medical devices

Circulars

• Danish Medicines Agency’s circular no 15015 of 19 August 1968 concerning radiation sterilisation of medical utensils (disposable equipment) predominantly consisting of plastic