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

Purpose

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.

Share this regulation