Imported medical device serious incident: what to do
Protect users, preserve the device and alert the legal manufacturer and UK Responsible Person immediately. Confirm who will assess and report the incident, and check the MHRA vigilance route without waiting for a completed investigation. Ask Cambridge China Bridge to help obtain factory records.
Protect users and record what happened
Arrange urgent clinical help where needed. Ask the care provider to secure the implicated device safely and arrange a suitable alternative. Put potentially affected stock on hold while the safety risk and batch scope are assessed.
Record when the event happened and when your business learnt about it, the device model, serial or batch identifier, reported harm, location and reporter’s contact details. Preserve the original complaint and distinguish observed facts from assumptions.
Identify your role and escalate
Check the label, declaration of conformity and supply agreement to identify the legal manufacturer and UK Responsible Person. If selling under your own name or trade mark, confirm with the MHRA whether you take on manufacturer responsibilities rather than merely importer responsibilities. Our medical device sourcing guide covers those market-entry roles. For registration coordination, see our guide to MHRA registration for medical device importers.
Send the incident record immediately to the manufacturer and UK Responsible Person, requesting acknowledgement and a named incident owner. The manufacturer remains legally responsible for vigilance even where tasks are delegated. Ask for written confirmation of who will assess reportability, submit the report and coordinate the investigation.
Preserve the device and its records
MHRA guidance says not to discard or repair an implicated device. If police or a coroner are involved, keep it until the MHRA contacts you. Do not send it to the MHRA unless specifically asked.
Photograph its condition, labels, packaging and accessories. Preserve settings, software versions, error logs, maintenance records and shipment records before they are overwritten. Agree safe handling and any decontamination with the care provider, documenting changes. Before any return to the factory, agree custody, transport and the proposed examination in writing.
Check the MHRA route without delaying
Use the MHRA vigilance collection listed in Sources to find the current reporting guidance and any device-specific advice. Manufacturers use MORE for incident reports. Patients, healthcare professionals and other users should consult the separate Yellow Card guidance, including the applicable local route.
For a potentially reportable incident, the manufacturer must report within the relevant timeframe even if reportability remains unclear. Incomplete information must not delay reporting. Ask the incident owner to confirm the applicable deadline and retain the submission acknowledgement and reference.
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Coordinate the investigation and follow-through
Request the factory’s production, component, inspection and change records for the implicated batch. Map affected stock and customer deliveries, and ask the manufacturer for the investigation plan, risk assessment and proposed customer instructions. Track acknowledgements and actions rather than accepting a replacement shipment as closure.
Keep regulatory reporting, customer safety work and the supplier claim moving together. Use our importer liability guide for liability questions and imported product recall guide for practical recall planning. Ask Cambridge China Bridge’s staff in China to help obtain and reconcile factory evidence.
Frequently asked questions
Am I the importer or the manufacturer?
Check the device label, declaration and supply agreement. If selling under your own name or trade mark, confirm your responsibilities with the MHRA. Confirm the role before assigning incident reporting.
Should I wait for the factory investigation?
No. Escalate immediately. For potentially reportable incidents, the manufacturer must meet the relevant reporting timeframe even if information is incomplete or reportability remains unclear.
Can I send the faulty device back to China?
Preserve it first and agree custody and examination arrangements. Do not discard or repair it. If police or a coroner are involved, keep it until the MHRA contacts you.
Do I use MORE or Yellow Card?
Manufacturers use MORE. Patients, healthcare professionals and other users should check the separate Yellow Card guidance and applicable local route. Confirm your reporting capacity with the incident owner.