+41 32 513 6767 | This email address is being protected from spambots. You need JavaScript enabled to view it.

On 1 September 2020 the UK MHRA published a new guidance on how medical devices and IVDs will be regulated after the end of the transition period. 

Most important updates from this guidance are as follows:

  • Products need to be notified at the MHRA from 1 January 2021 with the following transition periods:
    • 1 May 2021 class III, IIb, implantable, active implantable medical devices and List A IVDs
    • 1 September 2021 all other class IIb, IIa and List B IVDs and self-test IVDs
    • 1 January 2022 class I medical devices and general IVDs.
  • Manufacturers from outside the UK need to have a responsible person in the UK with a place of business in the country within the same transition period that applies for the product notification. 
  • CE-certified products are recognized until 30 June 2023 (regardless of whether the CE was obtained through a Directive or Regulation). 
  • A new GB route to the market and a UK Conformity Assessment Mark (UKCA) was announced. The new route will be recognized in parallel with the EU CE certification from 1 January 2021. From 1 July 2023 the UKCA mark and the associated certification by a UK Approved Body will be mandatory. 
  • Manufacturers of Class I products can continue to approve their products through self-declaration, and from 1 January 2021 they can mark them with the UKCA mark. The basis for this will be the UK MDR 2002 (status 1 January 2021).
  • The MHRA will begin designating conformity assessment bodies in January 2021, the assessment will be according to UK MDR 2002 (status 1 January 2021). UK Notified Bodies with designations for the Medical Device Directives (MDD, IVDD, AIMDD) will be recognized as UK Approved Bodies without further testing.

Next steps

  • Make sure to register your products with the MHRA within the given timeframe. 
  • Set up contracts with a UK representative.

If you need any support or have additional information please do not hesitate to contact us under This email address is being protected from spambots. You need JavaScript enabled to view it.