On 1 August 2023, the UK Department for Business and Trade (DBT) announced that CE marks would continue to be recognised in Great Britain (GB) indefinitely for virtually all goods, including toys, fireworks and radio equipment.

In effect, the UK Government has largely abandoned its version of the CE Mark, the UKCA Mark.

Before the announcement, these goods would have needed to bear a UKCA mark by 31 December 2024 in order to be lawfully placed on the GB market. Given that the requirements for a UKCA mark were to be identical to the requirements for a CE mark, dual certification appeared redundant, costly and burdensome.

Crucially for our purposes, the MHRA confirmed that the indefinite recognition of CE marks does not apply to medical devices. The UK recently changed the legislative framework for medical devices (the UK Medical Devices Regulations 2002 as amended (the UK MDR)) to extend acceptance of CE marked medical devices on the GB market until 30 June 2030 at the latest.[1]

UKCA marks – only for innovative products?

Might the abandonment of UKCA marks for most goods signal the end of UKCA marks for medical devices altogether? Earlier this year, we speculated that the Government’s Spring Budget speech indicated the cut-off date for GB recognition of CE marked medical devices might be scrapped.

The UK Government have also made clear its intention to simplify and expedite regulatory approval for medical devices; abandoning the requirement for UKCA marks on GB medical devices would go some way in achieving this.[2] It may be that the Government will extend CE mark recognition for medical devices indefinitely closer to the first significant deadline in 2028.

Even if the UK Government does abandon the UKCA mark for medical devices approved elsewhere, we expect the UKCA mark to be retained for innovative devices. The UK Government has trumpeted an Innovative Devices Access Pathway (IDAP) that would allow the MHRA to authorise early market access for new devices that meet a critical unmet need. This temporary authorisation for innovative devices would enable a manufacturer to commence commercialising the device while (a) gathering the comprehensive data needed to support a Conformity Assessment and (b) waiting for the conclusion of the Conformity Assessment. The IDAP will streamline the regulatory process for innovative devices, especially those that may find it difficult to generate the required standard of evidence for a Conformity Assessment, to ensure UK patients have access to innovative devices.

The Government continues to depict the UK as a global hub for innovation and to position the UK as having the world’s fastest and simplest regulatory approval process. As such, there may still be space for UKCA marks on the GB market yet.

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[1] The deadlines for CE mark recognition have been extended to:

• 30 June 2028 for ‘legacy’ medical devices (i.e. those compliant with the EU Medical Devices Directive (EU MDD)); and
• 30 June 2030 for ‘legacy’ IVDs (i.e. those compliant with the EU In Vitro Diagnostic Directive (EU IVDD)), and EU Medical Devices Regulation (EU MDR) compliant medical devices.

[2] The Government declared in its Spring Budget speech that from 2024, the MHRA will allow ‘rapid, often near automatic sign-off for medicines and technologies already approved…in other parts of the world’ and ‘set up a swift new approval process for the most cutting-edge medicines and devices’.

Reform proposals from the Life Sciences Council Advisory Group also noted an intention to'[e]xplore greater flexibility over the requirements for physical UKCA markings on parts, instructions and labels before products can be marketed in the UK’ and to expand recognition of foreign approvals for medical devices.