UK market access transition timelines for CE-marked IVDs and Medical Devices
Understanding the changes to the UK Regulations in the context of the EU transitions is an ongoing challenge. MHRA has issued new guidance, including handy infographics to help wrap your head around this tricky subject.
What does it mean for IVDs?
Apparently, one of the key misunderstandings relates to IVDs which currently have a CE certificate. All IVDD CE certificates will expire by 26 May 2025 at the latest, so the CE certificate cannot be used for market access to the UK after this time.
Let's take the example of a Class C that was in Annex II List B under the IVDD, like Rubella. This will need to transition to the IVDR or find a UK Approved Body willing to issue a UKCA Certificate to the UK MDR 2002 for UK market access from 26 May 2025.
Many manufacturers think they have until the class C transition date for these devices, which is incorrect.
The other important note for IVD manufacturers is note 2 on the infographic. IVDs that were classified as general IVDs under the IVDD (could be class B, C, or D) where the declaration of conformity to the IVDD requirements was made BEFORE 26 May 2022 can use this declaration of conformity for market access in the UK until 30 June 2030.
If you have a new device, you will have to use the UKCA route for market access, but you MUST make your declaration to the UK Medical Device Regulations 2002 BEFORE 30 June 2025.
What does it mean for medical devices?
Although the MHRA published practical guidance on their position for medical devices reliant on expired/expiring CE certificates in April 2023, it was not clear what the implications for Class I devices would be. The infographic and the updated guidance shed light on it.
It has already been clarified that Class I devices self-declared under the EU MDD, which will require the involvement of a notified body under the EU MDR, will be accepted onto the UK market as self-declared EU MDD devices till 30 June 2028 (where the MDD declaration of conformity was signed BEFORE 26 May 2021), with an EU MDR certificate being required afterward.
Less clear were the transitional arrangements for class I devices that continue not to require the involvement of a notified body under the EU MDR. Based on an EU MDR Declaration of Conformity, the latest infographic clarifies those will be accepted in the UK market until 30 June 2030.
Class III and IIb implantables with a valid MDD certificate can be placed on the UK market until 31 December 2027. Furthermore, all devices that are CE marked according to EU MDR can be placed on the UK market until 30 June 2030 before they require UKCA certification.
There are some differences in the timelines for Northern Ireland with respect to the extension of CE certificates. Where the UK has set the timelines to June each year for certain risk classes, Northern Ireland accepts the devices until December of that year. For example, Class IIa MDD devices are allowed until 30 June 2028, while Northern Ireland accepts them until 31 December 2028.
It certainly makes your brain ache, but the guidance and particularly the diagram are very much welcomed. Important dates to put in your diary!
The Statutory Instrument that extends the Standstill Period for recognition of the European CE Mark has been published:
The Medical Devices (Amendment) (Great Britain) Regulations 2023 (legislation.gov.uk)
Timelines for placing CE marked IVDs and Medical Devices on the Great Britain market
Link to the Infographic |
Guidance on registration of certain medical devices
Link to the updated guidance medical devices
If you have additional questions please send them to globalreg@qservegroup.com.