Medical Device Regulations 2017 Uk

The new regulations will apply across eu member states from 26 may.

Medical device regulations 2017 uk.

I legislative acts regul ations regul ation eu 2017 745 of the european parliament and of the council of 5 apr il 2017 on medical devices amending directive 2001 83 ec regulation ec no 178 2002 and. A new interactive online guide from the uk mhra provides high level overviews of new european medical device and ivd regulations. Although the united kingdom will have officially left the european union by the end of march 2019 the country is continuing to regulate medical devices using the mdr and ivdr regulations which were introduced in may 2017. These directives are transposed into uk law in the medical devices regulations 2002 si 2002 no 618 as amended uk mdr 2002.

Entering into force on 25 may 2017 the three and five year transition periods also known as implementation are now underway. Regulation 2017 745 on medical devices eu mdr. Medical devices regulations 558 kb regulations are current to 2020 09 09 and last amended on 2019 12 16. Medical devices regulations 238 kb pdf full document.

Both regulations entered into force in may 2017 and have a staggered transitional period. Added a new section on covid 19 medical devices guidance. The new guide should prove useful for ce mark certificate holders has they prepare for full compliance with the medical devices regulation mdr 2017 745 and in vitro diagnostic regulation ivdr 2017 746. Added a link to guidance for manufacturers who don t design or manufacture devices but place their names.

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 text with eea relevance.