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.

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Conduct a regulatory operations audit to identify duplication and inefficiency in your post-market surveillance process. Consider outsourcing PMCF data collection to a CRO. Invest in regulatory information management software. Ensure your QMS is fit for purpose for current UK MDR requirements.

This problem is Solvable.

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.

The primary root causes stem from the post-Brexit regulatory divergence, leading to the UKCA marking requirements and a separate regulatory framework from the EU MDR/IVDR.
This creates a dual burden for companies operating in both markets.
Additionally, many smaller companies lack the dedicated regulatory infrastructure and expertise to efficiently manage complex post-market surveillance (PMS) obligations, such as PMCF studies, vigilance reporting, and technical file maintenance, leading to resource drain and compliance risks.
The evolving nature and increasing complexity of these regulations further exacerbate the problem.

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.

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

What it looks like in practice

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

Paul Robinson

14 years in UK private healthcare

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