Medical Device Regulations 2017 Uk

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.

Medical device regulations 2017 uk.

Regulation eu 2017 745 of the european parliament and of the council show full title. 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. 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.

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. 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. 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.

Entering into force on 25 may 2017 the three and five year transition periods also known as implementation are now underway. 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. Both regulations entered into force in may 2017 and have a staggered transitional period.

Added a new section on covid 19 medical devices guidance.