Recalls — process & MHRA coordination
Recall obligations arise from Regulations 16–22 of the UK MDR 2002 and MHRA's adverse incident reporting guidance. MHRA has powers to require recalls under the UK MDR 2002 and can take independent action if a manufacturer fails to act promptly.
What is a recall?
In the medical device context, "recall" is used broadly to cover any action that removes devices from the supply chain or from use. MHRA distinguishes between:
| Action | Description |
|---|---|
| Market recall | Return of devices from distributors, importers, and stockists — devices not yet reached healthcare facilities or patients |
| User-level recall (hazard alert) | Devices already in use at healthcare facilities are returned, quarantined, or taken out of service |
| Patient-level recall | Devices already implanted in or being used by patients require action — the most complex and sensitive type |
| Modification / retrofit | Devices are not returned but are modified in place (software update, hardware fix) |
| Restriction of use | Devices remain in use but with amended indications, contraindications, or monitoring requirements |
Recall levels
MHRA classifies recalls (informally aligned with international practice) by the level of risk:
| Level | Risk | Typical action |
|---|---|---|
| Class 1 | Serious or life-threatening | Immediate recall; urgent FSN; MHRA close oversight |
| Class 2 | Could cause adverse health consequences but not life-threatening | Prompt recall; FSN; MHRA monitoring |
| Class 3 | Unlikely to cause harm but recall initiated to address non-conformity | Orderly recall; FSN |
The recall process
Step 1: Decision to recall
The manufacturer identifies the issue, determines that recall is the appropriate FSCA, and documents the decision (risk assessment, CAPA record).
Step 2: MHRA notification
Notify MHRA within 10 calendar days of the recall decision. Submit via the MHRA Submissions portal with the draft FSN and distribution list.
Step 3: Issue the FSN
Send the FSN to all affected parties (distributors, healthcare facilities, users) with clear instructions on what to do with affected devices.
Step 4: Execute the recall
- Collect returned devices from distributors and healthcare facilities
- For user-level recalls: coordinate with hospitals and clinics for device quarantine or return
- For patient-level recalls: work with healthcare facilities to identify affected patients and arrange appropriate follow-up
- Maintain a record of all affected devices returned, quarantined, or confirmed destroyed
Step 5: Verify completion
The recall is not complete until all affected devices have been accounted for. Evidence of completion includes:
- Acknowledgement records from distributors and healthcare facilities
- Return records with device identification numbers
- Destruction certificates (where devices are disposed of)
- Reconciliation of the number of devices distributed vs devices accounted for
Step 6: Report to MHRA
Submit a final report to MHRA confirming the recall is complete, with the reconciliation data and any outstanding items (devices that could not be located).
Patient-level recalls
When a recall involves devices already implanted in or being used by patients, additional considerations apply:
- Implant registries — where available, contact registries to identify affected patients
- Healthcare facility cooperation — hospitals must identify affected patients from their records
- Patient communication — MHRA may advise on appropriate patient communication; this requires careful clinical judgment
- Clinical risk assessment — for implants, the risk of explanation vs the risk of leaving the device in situ must be carefully assessed by clinicians
- MHRA involvement — MHRA may take a more active coordination role for high-profile patient-level recalls
MHRA's recall powers
MHRA can independently require a manufacturer to recall a device if MHRA concludes there is an unacceptable risk and the manufacturer has not acted adequately. MHRA can also:
- Issue public warnings about specific devices
- Work with other regulators to coordinate recalls affecting multiple markets
- Require importers or distributors to cease supply of affected devices pending investigation
Related pages
- When an FSCA is required
- Field Safety Notices (FSNs)
- MHRA-initiated safety actions
- Distribution records
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Regulations 16–22 | Recall obligations |
| MHRA: Adverse incident reporting guidance | Recall process guidance |
| MHRA: Device alerts | Published recalls — gov.uk |