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
- Structural root causes include the complexity and evolving nature of MHRA medical device regulations, particularly for SMEs with limited dedicated regulatory resources.
- Behavioural causes often stem from a lack of comprehensive staff training on vigilance requirements and a culture where incident reporting is not prioritised or is seen as burdensome.
- Systemic issues involve inadequate quality management systems that fail to integrate robust incident identification, assessment, and reporting workflows across all relevant departments.
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.
How to fix it
Implement a vigilance management system with clear event identification, triage, and reporting workflows. Train all customer-facing staff to recognise and escalate potential adverse events. Appoint a named vigilance officer. Conduct a retrospective review of recent events to identify any missed reports and consider voluntary disclosure to the MHRA.
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.