On 1 August 2023, the UK government announced plans to extend recognition of CE marking ‘indefinitely’ for certain products placed on the Great Britain market (England, Wales and Scotland).
However, medical devices are not among the categories of products concerned by the indefinite recognition of CE marking. Instead, the UK government has been working to introduce regulations to substantially reform the current regulatory framework governing medical devices in the UK. The future UK regime for medical devices is expected to apply from 1 July 2025.
In the meantime, the UK government has amended the Medical Device Regulations 2002, SI 2002 No 618, as amended, (UK MDR) to extend the recognition of CE marked medical devices in Great Britain for a limited period. The amendments provide transitional arrangements to minimize disruption to the supply of medical devices in Great Britain. The amendments also provide that CE marks will cease to be recognized in Great Britain on 30 June 2030, at the latest. Shorter deadlines may apply depending on the regulatory framework on the basis of which the CE mark is affixed and the classification of the medical devices. In addition, CE marks may cease to have effect before the deadlines established in the amended UK MDR – if CE Certificates of Conformity expire, or if related application of European Union law renders the CE Certificates of Conformity invalid at an earlier date. Accordingly, CE marked medical devices can be placed on the Great Britain market until the following deadlines.
|Medical device classification||Latest deadline|
|Medical devices CE marked in accordance with Directive 93/42 on medical devices (MDD) or Directive 90/385 on active implantable medical devices:|
|Class III and Class IIb implantable||31 December 2027|
|Class IIb, Class IIa, Class I measuring or sterile medical||30 June 2028|
|Class I medical devices which were self-assessed under the MDD, for which an EU Declaration of Conformity was issued in accordance with the MDD prior to 26 May 2021, and for which the conformity assessment under Regulation 2017/745 on medical devices (MDR) will require the involvement of a notified body||30 June 2028|
|In vitro diagnostic medical devices (IVDs) CE marked in accordance with Directive 98/79 on IVDs (IVDD):|
|List A, List B or self-testing IVDs||26 May 2025|
|General IVDs which were self-assessed under the IVDD, for which the EU Declaration of Conformity was issued in accordance with the IVDD prior to 26 May 2022, and for which the conformity assessment under Regulation 217/746 on IVDs (IVDR) will require the involvement of a notified body||30 June 2030|
|Medical devices and IVDs CE marked in accordance with the MDR or IVDR||30 June 2030|