For UK MedTech companies
Post-market surveillance is eating your operating budget, not protecting your patients
Since the UK retained MDR 2002 post-Brexit, compliance obligations have grown sharply. For smaller medtech companies, regulatory costs have risen sharply in recent years, often without a proportionate gain in product safety outcomes.
Two minutes. Solva follows up with specific regulatory resource options.
- Increased time and resources spent on documentation and technical file updates
- Delays in bringing new MedTech products to the UK market
- Frequent audits and inspections from the MHRA or Approved Bodies
- Difficulty attracting and retaining regulatory affairs talent
- Increased workload for regulatory and quality teams
- Slower product development cycles
- Higher operational costs due to increased compliance efforts
- Potential fines and penalties for non-compliance
- Delayed patient access to innovative medical technologies
- Reduced availability of certain medical devices in the UK market
- Damage to brand image and trust among healthcare providers and patients
- Negative media coverage in case of regulatory breaches
UK MedTech companies report significant increases in regulatory costs, with 20% experiencing over 50% increases in the last 12 months (ABHI, 2024)
Source: https://www.abhi.org.uk/media/fvhmxqbi/2024-pulse-of-healthtech-survey.pdf
Frequently asked questions
Why does this problem persist?
UK MDR 2002 (as retained post-Brexit) and UKCA marking requirements have significantly increased post-market surveillance obligations for MedTech companies. Many smaller companies lack the regulatory infrastructure to manage PMCF studies, vigilance reporting, and technical file maintenance efficiently, leading to compliance risk and resource drain.
What is the cost of leaving it unaddressed?
Regulatory compliance costs for MedTech SMEs are substantial, with some companies experiencing over 50% increases in regulatory fees (ABHI, 2024). Specific figures of 22% of operating budget and £440,000 resource drain are not directly verifiable from public ABHI 2024 reports.
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.