For UK MedTech companies
You have CE and FDA clearance, but UKCA is blocking your path to market
Post-Brexit divergence means CE marking no longer guarantees UK market access. UKCA requirements, MHRA registration, and shifting transition timelines are a distinct regulatory pathway, and a failed submission is expensive to put right.
Two minutes. Solva follows up with specific regulatory pathway options.
- Delays in obtaining UKCA marking due to limited Approved Body capacity and extended review times
- Increased administrative burden and resource allocation for managing dual regulatory pathways (CE and UKCA)
- MedTech companies prioritizing other markets (e.g., US FDA) over the UK due to perceived easier or faster market access
- Reduction in the availability of innovative medical devices in the UK market as manufacturers withdraw products or deprioritize UK launches
- Increased administrative burden and resource allocation for managing dual regulatory pathways (CE and UKCA)
- Delays in product launches and market access due to extended conformity assessment timelines and limited Approved Body capacity
- Increased operational costs due to the need for dual regulatory compliance and maintaining separate technical documentation for UKCA and CE marking
- Significant financial losses from delayed market entry, potentially impacting revenue generation and return on investment for new medical devices
- Reduced access to innovative medical devices and advanced treatment options for UK patients due to manufacturers deprioritizing the UK market
- Potential delays in patient access to new and improved medical technologies
- Damage to the UK's reputation as an attractive market for MedTech innovation and investment, potentially deterring future foreign direct investment
- Erosion of trust among international partners and manufacturers due to perceived regulatory instability and divergence from established global standards
The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation, leading to significantly increased costs for device development and market access. (Beddoe-Rosendo et al., 2023)
Frequently asked questions
Why does this problem persist?
The divergence from EU MDR/IVDR post-Brexit has created a complex and evolving regulatory framework. UKCA marking requirements, MHRA registration, and the transition timelines are different from every other market and change frequently.
What is the cost of leaving it unaddressed?
A failed UKCA submission for Class I, IIa, and non-high-risk IIb devices costs £11,701 for resubmission, while for high-risk Class IIb, Class III, and active implantables, resubmission costs £22,678. (Morulaa, 2026)
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.