UNITED KINGDOM —As the UK government extends the recognition of CE marking for most goods, questions arise regarding the fate of medical devices under this regulatory shift.

The government’s decision, however, comes with a noteworthy exception—medical devices remain excluded from this indefinite extension.

Yet, this doesn’t signify a halt to the progress. The UK government reaffirms its commitment to the medical device industry through a strategic amendment to the Medical Device Regulations, allowing for an extended acceptance of CE-marked medical devices within the Great Britain market.

General medical devices that comply with the European Union medical devices directive or EU active implantable medical devices directive, complete with a valid declaration and CE marking, hold the privilege of entering the Great Britain market until the certificate’s expiration or until June 30, 2028, whichever arrives first.

Similarly, in vitro diagnostic devices (IVDs) that align with the EU in vitro diagnostic medical devices directive secure a market entry window until June 30, 2030, or until the certificate expires—again, the earlier of the two.

Furthermore, the embrace of EU medical devices regulations (EU MDR) extends to general medical devices, including custom-made variants, allowing them to grace the Great Britain market until June 30, 2030.

This synchronized approach underscores the UK government’s dedication to maintaining a seamless flow of medical devices within its regulatory framework.

The future of UKCA marks for medical devices

Pioneering industry minds, Alex Denoon and Vivien Zhu from the Bristows law firm, delve into the implications of this extended CE marking.

A pertinent question emerges—could this development signal the eventual demise of UKCA marks (UK Conformity Assessment) even within the realm of medical devices?

Their contemplation is rooted in the government’s larger objective to simplify and expedite medical device approvals, which could potentially render UKCA marks redundant.

While this transition might predominantly affect conventional devices, the realm of innovative creations might remain unaffected.

Denoon and Zhu emphasize that, regardless of potential shifts, the UKCA mark might continue to find its place for innovative devices, exemplified by the Innovative Devices Access Pathway (IDAP).

The Innovative Devices Access Pathway (IDAP)

Projected for launch later this year, the IDAP brings together the expertise of the Medicines and Healthcare products Regulatory Agency (MHRA) and other esteemed healthcare entities.

This pathway offers a streamlined route for early market access to innovative devices, catering to unmet medical needs.

Manufacturers can embark on commercialization while concurrently gathering comprehensive data to support a robust UKCA mark application.

The IDAP reflects the government’s vision of positioning the UK as a global innovation hub with an expeditious and efficient regulatory approval process.

As Denoon and Zhu affirm, this pathway ensures that the UK remains a thriving ground for cutting-edge medical innovations while maintaining the overarching goal of patient welfare and transformative healthcare outcomes.

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