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