Legislation

REGULATIONS

Regulation (EU) 2017/745 on medical devices (MDR)
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
  • 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

  • Corrigenda and an amendment of the regulation were adopted and published:
    • the first corrigendum was adopted on 13 March 2019 and published on 3 May 2019: link to the first corrigendum [ENG]
    • the second corrigendum was adopted on 3 December 2019 and published on 27 December 2019: link to the second corrigendum [ENG]
    • Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

  • Unofficial consolidated text of Regulation (EU) 2017/746 with amendments. 

ACTS AND RULES

DIRECTIVES

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