Medical Device Regulations 2017 Uk

Added a new section on covid 19 medical devices guidance.

Medical device regulations 2017 uk.

Regulation 2017 745 on medical devices eu mdr. Both regulations entered into force in may 2017 and have a staggered transitional period. The new regulations will apply across eu member states from 26 may. Added a link to guidance for manufacturers who don t design or manufacture devices but place their names.

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. 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. Medical devices regulations 558 kb regulations are current to 2020 09 09 and last amended on 2019 12 16. The adoption in april 2017 of regulation eu 2017 745 on medical devices mdr and regulation eu 2017 746 on in vitro diagnostic devices ivdr changed the european legal framework for medical devices introducing new responsibilities for ema and for national competent authorities.

These directives are transposed into uk law in the medical devices regulations 2002 si 2002 no 618 as amended uk mdr 2002. However elements of both new devices regulations have applied directly in uk law since may 2017 meaning medical devices including ivds can now be legally placed on the uk market if they are in. A new interactive online guide from the uk mhra provides high level overviews of new european medical device and ivd regulations. Medical devices regulations 238 kb pdf full document.

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.