MDR starts 26 May 2021
2 new Regulations (Medical Device Regulation or MDR and in vitro Diagnostic Devices Regulation IVDR) are replacing the 3 existing Directives.

 2 new Regulations (MDR and IVDR) are replacing the 3 existing Directives.They entered into force on 25 May 2017 and will progressively replace the existing directives after a transition period.

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Starting May 2021.
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Starting May 2022.

Medical devices within the EU are currently regulated by 3 Directives:

Visit  https://ec.europa.eu/health/md_sector/overview_en for more information

Regulations
#mdr#ivdr#EU_Health
Mariana Pacheco
20. 5. 2021 15:42