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.

steps: 7; steps
to start: 1 day; to start

The short answer

Since 16 June 2025, manufacturers must report serious incidents in Great Britain to the MHRA within 2, 10 or 15 calendar days depending on severity, counted from when the manufacturer first becomes aware. That clock depends on your sales staff, clinical specialists, distributors and private hospital customers telling you about problems quickly. Name a vigilance lead, give every customer-facing person a 24-hour escalation rule and a simple decision tree, and test the process with a mock incident.

7 steps

Do it yourself: step by step

0 of 7 done

Name one person accountable for assessing and reporting incidents, plus a trained deputy for absence
Time
1 day
Typical cost
Internal time
Who does it
Founder
Done when: Names and contact details published internally and to distributors
Cover how complaints are received, how they are assessed against the serious incident definition, the 2, 10 and 15 calendar day reporting timelines, trend reporting, field safety corrective actions and record keeping, in line with MHRA guidance
Time
2 to 4 weeks
Typical cost
Internal time, or £2,000 to £5,000 for consultant support (Solvable estimate: 2 to 5 days at about £1,000 a day)
Who does it
Vigilance lead
Done when: An approved procedure exists and references the current MHRA guidance

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Incident escalation and reporting decision checklist

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Checklist

Incident escalation and reporting decision checklist

For internal use. Check current MHRA guidance for definitions and timelines. This checklist supports, not replaces, your vigilance procedure.

Part A: for anyone who hears about a problem (sales, clinical specialists, customer service, distributors)

Escalate to the vigilance lead within 24 hours if any of these apply. If in doubt, escalate.

A patient, user or other person was harmed, or could have been
The device failed, broke or did not perform as intended
The instructions or labelling were wrong or confusing
The customer mentions an internal incident report or an MHRA Yellow Card report

Send: [vigilance inbox or form link] Call if urgent: [vigilance lead phone], deputy [phone]

Details to capture

Hospital or clinic, contact name and phone
Device name, model, lot or serial number
Date of the event
What happened, in the customer's words
Any harm to a patient or user
Whether the device is available for return

Part B: for the vigilance lead

[ ] Complaint logged with date and time received (this starts your clock)
[ ] Is it a serious incident under MHRA definitions? Yes / No / Unsure
[ ] If yes, which timeline applies?

Serious public health threat: report within 2 days
Death or unanticipated serious deterioration in health: within 10 days
Other serious incident: within 15 days

[ ] Report submitted via the MORE portal on [date]
[ ] Device return and investigation started
[ ] Need for field safety corrective action considered and recorded
[ ] UK Responsible Person and approved body informed where required
[ ] Included in trend analysis
[ ] Follow-up and final reports submitted on [dates]
[ ] Customer kept informed

Part C: if it is not reportable

Reason recorded and signed by vigilance lead
Logged for trend analysis

Avoid these

Common mistakes

Starting the reporting clock from when the regulatory team hears about it, not when the company first knew.
Sales staff deciding for themselves that a complaint is not serious.
Distributor contracts that say nothing about passing on complaints.
Only one person with MORE portal access, who is on leave when it matters.
Still working to the old 30-day timeline for all serious incidents.

Free personal check

Done by Paul Robinson, not software

I'll check your vigilance process against the MHRA timelines and show you where reports could run late

What I need from you

Answers to 7 tap questions
Your company website

What you get

Where the reporting clock is most at risk
Gaps in your escalation route
A mock incident you can run next month

Within 2 working days

No sign-in, no sales call. I read every request myself and reply on WhatsApp.

Free tools

Check where you stand

Your illustrative estimate

£15,000

Solvable estimate. Rounded to the nearest £500. Updates as you type.

Probability of finding per year

Starting figure 10% (from 10% (Solvable estimate)). Change it to match your practice.

Cost of remediation and disruption

Starting figure £150,000 (midpoint of £150,000 (Solvable estimate: for example 30 to 60 days of consultant time at about £1,000 a day, plus staff time and delayed sales)). Change it to match your practice.

Formula

Expected cost of a weak vigilance process = probability of a significant regulatory finding a year × cost of remediation and disruption

Variables and defaults

probability_of_finding_per_year: 10% (Solvable estimate)
cost_of_remediation_and_disruption: £150,000 (Solvable estimate: for example 30 to 60 days of consultant time at about £1,000 a day, plus staff time and delayed sales)

Defaults only. Change them in the calculator to use your own numbers.

Assumptions and defaults

probability_of_finding_per_year = 10% (Solvable estimate)
cost_of_remediation_and_disruption = £150,000 (Solvable estimate: for example 30 to 60 days of consultant time at about £1,000 a day, plus staff time and delayed sales)

Puts an expected value on the risk; with these defaults about £15,000 a year (10% × £150,000). A single finding could cost £50,000 to £250,000 (Solvable estimate, same basis). This is risk avoided by the steps, not cash recovered.

Benchmarks

Serious incident reporting timelines in Great Britain: 2 calendar days for serious public health threats, 10 for death or unanticipated serious deterioration in health, 15 for other serious incidents (previously 30), from when the manufacturer first becomes aware
Applies since the new GB PMS requirements took effect on 16 June 2025
Source: MHRA vigilance reporting requirements, GOV.UK
The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 added Part 4A to the UK MDR 2002 and came into force on 16 June 2025
The legal basis for current vigilance duties
Source: MHRA press release and guidance on GOV.UK
Serious incident, trend and field safety corrective action reports must go through the MHRA's MORE portal; the MHRA does not accept other routes
One reporting route, so access matters
Source: MHRA vigilance reporting requirements, GOV.UK

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.

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.

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)

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

What it looks like in practice

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

Paul Robinson

14 years in UK private healthcare

I solve this one for healthcare companies

Want a hand? I'll look at your situation and tell you the three things I'd tackle first.

A few quick questions, about two minutes. I read every one myself and usually reply the same day.

No sales call unless you ask for one. Just a straight answer from me.

I reply personally, usually the same day.

Questions

Frequently asked questions

When does the reporting clock start?

MHRA guidance counts the deadline from when the manufacturer first becomes aware of the incident. Treat a report to your sales staff or distributors as the start, so it reaches the vigilance lead fast.

How do we report to the MHRA?

Manufacturers report serious incidents, trends and field safety corrective actions through the MHRA's MORE portal, which is the only accepted route. Hospital staff and patients report through the Yellow Card scheme.

What if we are not sure whether it is reportable?

Escalate and assess quickly. MHRA guidance says incomplete information is not a reason to delay. Record your reasoning either way.

What if we find old incidents that were not reported?

Take regulatory advice promptly on how to handle them. Do not ignore them.

Do distributors report to the MHRA for us?

The manufacturer is responsible for reporting. Distributors must pass complaints to you quickly, so put that in the contract.

Is this legal advice?

No. This is general information. Check current MHRA guidance and take advice from a regulatory specialist for your devices.

Last reviewed: 30 October 2026

Sources

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The short answer

Do it yourself: step by step

1Appoint a vigilance lead and deputy1 day · Internal time

2Write a short vigilance procedure2 to 4 weeks · Internal time, or £2,000 to £5,000 for consultant support (Solvable estimate: 2 to 5 days at about £1,000 a day)

3Train everyone who talks to customers1 to 2 hours per person, then annually · None

4Make escalation easy1 to 2 weeks · None

5Set up MHRA reporting access1 day · None

6Review past complaints2 to 4 weeks · Internal time, or consultant support

7Run a mock incidentHalf a day, twice a year · None

Incident escalation and reporting decision checklist

Common mistakes

I'll check your vigilance process against the MHRA timelines and show you where reports could run late

What I need from you

What you get

Check where you stand

What's this costing you?Optional: work it out with your own numbers

How we worked this outMethod, formula and assumptions

Why this keeps happening

What it leads to

Evidence

Want a hand? I'll look at your situation and tell you the three things I'd tackle first.

Frequently asked questions

When does the reporting clock start?

How do we report to the MHRA?

What if we are not sure whether it is reportable?

What if we find old incidents that were not reported?

Do distributors report to the MHRA for us?

Is this legal advice?

You're not the only one with this problem.