Medical Devices – Latest Updates

UK MDR: Great Britain extends the acceptance of CE marked medical devices and IVDs

27 June 2023

With the initial transitional period for CE marked medical devices expiring on 30 June 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has brought forward a legislation allowing to continue to place CE marked medical devices on the market in Great Britain. With this measure, the government intends to lessen the pressure on the industry and ease the transition to the new regulatory framework. The new timelines apply to:

The extension periods also apply to self-declared CE marked Class I medical devices, as follows:

  • Medical devices self-declared against EU MDR requirements – until 30 June 2030
  • Medical devices, including unclassified devices and reusable surgical instruments, self-declared against MDD requirements before 26 May 2021 and requiring Notified Body involvement under EU MDR – until 30 June 2028
  • Class I medical devices with a sterile or measuring function and a valid MDD certificate – until 30 June 2028.
Devices Compliant with Timeline
General medical devices
EU MDD or EU AIMDD with a valid declaration and CE marking
Until the expiry of certificate or 30 June 2028, whichever comes first
General medical devices, incl. custom made devices
Until the expiry of certificate or 30 June 2030, whichever comes first
In vitro diagnostic medical devices (IVDs)
Until the expiry of certificate or 30 June 2030, whichever comes first
Until the expiry of certificate or 30 June 2030, whichever comes first

The new legislation does not apply to the following medical devices which cannot be placed on the market in Great Britain after 30 June 2023:

  • Custom made devices compliant with the EU MDD or AIMDD
  • Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body.

For further details on the new timelines, please refer to the MD Amendment Regulations 2023,  its summary or view the explanatory infographic provided by the UK government.

The UK government also intends to introduce further provisions later in 2023 to reinforce post-market surveillance requirements which are expected to apply from mid-2024.

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