For UK MedTech companies
Your CE mark will not protect your UK market access indefinitely
MHRA transition extensions have created a false sense of security. The direction of travel is fixed, and devices without UKCA marking will face removal from the Great Britain market when the deadline holds.
Two minutes. Solva follows up with specific regulatory pathway options.
- Backlogs at UK Approved Bodies leading to longer certification times
- Increased internal resource strain due to rushed compliance efforts
- Loss of market share or inability to launch new products in Great Britain
- Penalties or enforcement actions from the MHRA for non-compliance
- Delayed product launches and market access in Great Britain
- Diversion of internal resources from innovation to regulatory compliance
- Loss of revenue from inability to sell non-compliant devices
- Increased costs due to expedited regulatory services or consultants
- Delayed access to innovative medical devices for UK patients
- Reduced choice of medical devices for healthcare providers
- Damage to brand reputation due to non-compliance or product withdrawal
- Loss of trust from healthcare providers and patients
44% of UK MedTech companies had not begun their UKCA transition (ABHI Pulse of HealthTech Survey, 2024)
Source: https://www.abhi.org.uk/media/fvhmxqbi/2024-pulse-of-healthtech-survey.pdf
Frequently asked questions
Why does this problem persist?
Post-Brexit, medical devices sold in Great Britain require UKCA marking rather than CE marking. The MHRA has extended transition periods multiple times, creating uncertainty, but the direction of travel is clear. Companies that delay UKCA transition risk being unable to sell in the UK market and face a compressed timeline that increases cost and risk.
What is the cost of leaving it unaddressed?
No verified UK data available for the specific cost range of £40,000-£120,000 per Class IIb device for UKCA marking, though significant costs are associated with the process (MHRA, 2024)
This is exactly what I do with UK private practices. Answer the few questions above and I'll come back personally with where to start. Paul.