What's Happening?
The UK government is consulting on a proposal to indefinitely recognize CE-marked medical devices in Great Britain, a move aimed at ensuring continued access to these devices post-Brexit. The Medicines and Healthcare products Regulatory Agency (MHRA)
is addressing concerns about the expiration of CE mark recognition in 2028. The proposal would allow CE-marked devices to remain on the market without transitioning to the UKCA system. This initiative seeks to provide long-term certainty for the medtech industry and maintain patient access to essential medical devices.
Why It's Important?
The indefinite recognition of CE marks is crucial for the UK medtech industry, as it reduces regulatory friction and costs associated with transitioning to the UKCA system. This move supports the continued availability of medical devices, benefiting both patients and manufacturers. By aligning with EU standards, the UK can ensure that its healthcare system remains competitive and that patients have access to the latest medical innovations. The proposal also highlights the importance of regulatory stability in fostering industry growth and innovation.
What's Next?
The consultation period for the proposal will run until April 10, 2026. If implemented, the indefinite recognition of CE marks could set a precedent for other regulatory areas post-Brexit. The UK government may also explore further regulatory reforms to enhance the competitiveness of its medtech sector. Stakeholders, including industry representatives and healthcare professionals, are likely to engage in discussions to shape the final outcome of the proposal.
