For UK MedTech companies
Adverse events you reported late, or not at all, put your device licence at risk
MHRA vigilance obligations are strict, and SMEs without a defined reporting process routinely miss deadlines or misclassify events. A single enforcement action can suspend your device and disrupt millions in revenue.
Two minutes. Solva follows up with specific vigilance process options.
- An increase in 'near miss' incidents that are not formally documented
- Staff expressing confusion about what constitutes a reportable event
- Delayed or incomplete submissions to the MHRA's MORE portal
- Unannounced MHRA inspections resulting in non-compliance findings
- Diversion of internal resources to manage regulatory investigations
- Disruption to supply chain and distribution channels
- Significant MHRA fines and penalties (£5,000 fine and/or 6 months imprisonment for breaches)
- Costs associated with product recalls and rework (up to £5 billion annually across the industry)
- Delayed identification of device-related patient harm
- Continued use of unsafe devices
- Damage to brand image and market standing
- Loss of trust from healthcare providers and patients
No verified UK data available for the specific percentage of regulatory actions triggered by vigilance reporting failures.
Source: No direct verifiable source found for the specific statistic.
Frequently asked questions
Why does this problem persist?
MHRA vigilance reporting requirements are strict and non-compliance carries significant regulatory risk. Many MedTech companies, particularly SMEs, lack a robust process for identifying reportable events, determining whether an event meets the reporting threshold, and submitting reports within the required timeframe. Late or missed reports are a common trigger for MHRA inspection.
What is the cost of leaving it unaddressed?
Implementing a robust vigilance management system can range from £5,000 to £20,000, while potential device suspension due to non-compliance can affect millions in revenue. (Tracekey, 2025; Emergo by UL, 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.