In September, the UK’s MHRA published two major guidances concerning the regulatory environment for medical devices (MD) in the UK, applicable from January 1, 2021 (end of the transition period):
- The first one, very comprehensive, relates to the regulation of MD after the transition period.
- The second relates to the modalities of conformity assessment and placing on the market of the MD via the new UKCA marking. This guide helps to determine whether a UKCA marking is necessary and if so, what the rules are according to the type of product, risk class etc.
nexialist offers you here a summary of the information to remember :
- MD already CE marked in accordance with the Directives and/or Regulations may be placed on the UK market until June 30, 2023, at which time UKCA marking will become compulsory. This applies in particular as long as no Mutual Recognition Agreement (MRA) has been signed. You can also consult the status of negotiations between the United Kingdom and the other countries on this page.
- In any event, as of January 1, 2021, any MD manufactured outside the United Kingdom must be placed on the market under the responsibility of a “UK responsible person“, established in the territory in the image of the European authorised representative. It should also be noted that registration with the MHRA will become mandatory. These two obligations benefit from a grace period based on the risk class of the MD.
|MD class III, IIb implantable
IVDMD List A
|4 extra month||1st may 2021|
|MD other IIb, IIa
IVDMD List B and auto-test
|8 extra month||1st september 2021|
|MD others as class I
IVDMD : all the others
12 extra month
|1st january 2022|
- Northern Ireland retains its special status and will continue to use CE marking for medical devices placed on its market. For more information on this you can consult the Northern Ireland Protocol.