read

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.

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.

1. EU MDD = the EU medical devices directive↑
2. EU AIMDD = the EU active implantable medical devices directive↑
3. EU MDR = the EU medical device regulation↑
4. EU IVDD = the EU in vitro diagnostic medical devices directive↑
5. EU IVMDR = the EU in vitro diagnostic medical devices regulation↑