For UK HealthTech companies
You don't know if your product is a medical device, and that uncertainty has a legal price
Selling an unregistered medical device in the UK carries an unlimited fine and criminal prosecution. For software products especially, the line between regulated and unregulated is genuinely contested, and the wrong call blocks NHS procurement entirely.
Two minutes. Solva follows up with specific classification and pathway options.
- Product development delays due to unclear regulatory pathways
- Unexpected costs from re-classification or late engagement with Approved Bodies
- Market access restrictions or product recalls due to non-compliance
- Difficulty securing investment or partnerships without clear regulatory status.
- Increased workload for regulatory and quality teams
- Diversion of R&D resources to address compliance gaps
- Significant fines and legal costs for non-compliance
- Loss of revenue from delayed market entry or product withdrawal
- Damage to brand trust and credibility
- Negative publicity from enforcement actions or product issues
No verified UK data available
Source: No direct verifiable UK source found for specific percentages of enforcement actions against unregistered medical devices, particularly software products, for 2024.
Frequently asked questions
Why does this problem persist?
The boundary between regulated medical devices and unregulated wellness or clinical decision support software is genuinely ambiguous for many healthtech products. Post-Brexit, UK and EU regulatory pathways have diverged, and the MHRA's Software as a Medical Device guidance has created new obligations for products that previously fell outside regulation.
What is the cost of leaving it unaddressed?
Selling an unregistered medical device in the UK carries an unlimited fine and criminal prosecution. UKCA marking for a Class IIa software device costs £30,000–£80,000 and takes 12–18 months. Regulatory non-compliance can also block NHS procurement. (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.