Medicines and Healthcare products Regulatory Agency (MHRA) extended the timeframe for the acceptance of CE-marked Medical Devices and in vitro diagnostic (IVD) devices within the UK to ensure the continued safe supply of devices in the country.
On 14 June, MHRA published Statutory Instrument 2023 No. 627 ‘Medical Devices (Amendment) (Great Britain) Regulations 2023 extending the period for placing CE-marked Medical Devices and IVDs on the market.
Specifically, CE-marked Medical Devices may continue to be marketed according to different deadlines, namely:
- class III and class IIb implantable devices until 31/12/2027;
- class IIb, class IIa, class Is, Im and Ir devices until 30/06/2028;
- self-certified MDD class I devices, reclassified by the MDR, until 30/06/2028.
In the case of CE-marked IVD devices, marketing may continue as follows:
- self-declaration and class D devices until 26/05/2025;
- Class C devices until 26/05/2026;
- Class B and Class A sterile devices until 26/05/2027.
As mentioned, therefore, in order to ensure the presence of devices within the country’s healthcare facilities, the UK Regulatory Authority has extended the timeframe for the acceptance of Medical Devices and IVDs but also said it would review and update its regulations as of 01/07/2025. The latter is not likely to deviate significantly from European regulation in that the conformity assessment processes and standards to be used to demonstrate compliance under the UKCA mark will be almost the same as those applicable to the CE mark.
>>> If you want to market Medical Devices and IVDs in the UK, Thema can assist you with the Strategic Regulatory Consulting Service, can be your UK Responsible Person (UKRP) and can support you in registering products with MHRA.