05 Apr 2017
  • Adopted
  • Very high importance
  • Europe
  • Binding legal instruments (regulations, directives and decisions)
  • Entry Into Database 28 Jan 2021
  • Last revised in database 28 Jan 2021
  • Final act signed 05 Apr 2017
  • Final act published 05 May 2017
  • Entry of act into force 25 May 2017


The purpose of this Regulation is to ensure the functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. The Regulation sets standards of quality and safety for medical devices in order to meet common safety concerns as regards such products.

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