You did not build your company to spend its best energy navigating paperwork. You built it to move something that matters, a device, an idea, a breakthrough, from concept to clinic and from prototype to patient.
The ambition has always been clear: to get life-saving products into the hands of clinicians efficiently, without unnecessary friction or artificial delay.
In recent years, however, regulatory uncertainty has sat heavily in the background. The looming UKCA transition created what many described as a regulatory cliff edge.
Even where deadlines were extended, the underlying concern remained the same. At some point, the clock would run out and organisations would be forced into duplicate systems, dual testing and parallel conformity routes, not because patients demanded it, but because the calendar did.
That uncertainty did more than add administrative burden. It altered behaviour. Budgets were hedged. Launches were reconsidered. Cash was protected rather than deployed. Ambitious R&D roadmaps were quietly reshaped into cautious spreadsheets.
Now, there is a material shift in direction. The Medicines and Healthcare products Regulatory Agency has launched a consultation proposing the indefinite recognition of CE marked medical devices in Great Britain.
In practical terms, this signals a potential removal of the cliff edge that has been shaping strategic decisions across the sector.
If adopted, the implications are significant.
First, there are cost savings. The removal of a forced transition to parallel UKCA processes for CE compliant devices would reduce duplication.
Capital that might otherwise have been channelled into maintaining two regulatory tracks could instead be redirected towards innovation, market development or clinical education.
Second, there is predictability. Indefinite recognition of CE marking would allow portfolio strategy to be driven by patient need and commercial logic rather than regulatory deadlines. Greater predictability strengthens planning cycles, improves investor confidence and restores momentum to long term growth strategies.
Third, there is speed to market. Where a device already complies with EU MDR or IVDR standards, the proposed approach would maintain a clear pathway into Great Britain. This reduces additional hurdles and supports continuity of supply for the National Health Service and other providers.
The stakes are not abstract. Success would mean a thriving and open UK market, resilient supply chains and sustained global engagement from manufacturers. Failure would risk product withdrawals, delayed launches and R and D budgets diluted by avoidable compliance duplication.
The consultation is open until April 10, 2026. For MedTech leaders, this is not simply a regulatory update. It is an opportunity to shape the environment in which you operate. Reviewing the proposal and providing considered feedback will help determine whether the UK becomes a market defined by friction, or one defined by flow.
#MedTech #MHRA #MedicalDevices #RegulatoryStrategy #UKMedTech
FAQ
1. Does this mean UKCA marking is being scrapped?
No. UKCA is not being abolished. The proposal is about allowing CE marked devices to continue being recognised in Great Britain indefinitely. UKCA would still exist as a route, but the immediate pressure to transition purely because of a deadline would ease.
2. What exactly is being proposed?
The Medicines and Healthcare products Regulatory Agency is consulting on whether CE marked devices that comply with EU MDR or IVDR should be recognised indefinitely in Great Britain. This would remove the current end dates that create the so-called regulatory cliff edge.
3. Does this apply to all CE marked devices?
The proposal primarily focuses on devices compliant with EU MDR and IVDR. There are nuances around certain higher-risk classifications and reliance pathways. It is important to review the consultation details to understand how your specific device category may be treated.
4. Does this apply across the whole UK?
No. The proposal relates to Great Britain. Northern Ireland operates under separate arrangements aligned more directly with the EU framework.
5. Will manufacturers still have obligations in Great Britain?
Yes. Recognition of CE marking does not remove core responsibilities. Device registration, post-market surveillance, vigilance reporting, and other UK requirements would still apply.
6. What are the strategic implications for MedTech leaders?
If adopted, the proposal reduces duplication, restores predictability, and improves speed to market. It allows capital and leadership attention to return to innovation and supply rather than parallel compliance programmes.
7. What should you do now?
Review the consultation carefully. Consider how the proposal affects your portfolio, supply chain, and regulatory strategy. Submit feedback before the consultation closes on April 10, 2026.
Harun Rabbani 
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