Medical device UK Responsible Person: before ordering
Before ordering, verify the manufacturer's appointment directly with its UK Responsible Person. Agree the exact devices covered, document access, importer-detail submission and how complaints or changes reach the manufacturer. Record these arrangements before committing funds. Cambridge China Bridge can coordinate factory-side checks.
Start with the manufacturer’s appointment
This guide concerns supply to Great Britain. Our medical devices and PPE guide covers the basic appointment and registration requirements. Here, the buying decision is whether the manufacturer's appointed UK Responsible Person has confirmed arrangements that cover your proposed order.
MHRA guidance requires written evidence of the manufacturer's authority. Ask to see that evidence, then contact the UK Responsible Person independently to confirm the appointment remains current. Match the manufacturer's identity against the declaration of conformity and order documents. Ask the manufacturer to authorise direct communication with you.
Match coverage to the goods you will buy
Prepare a device schedule showing the manufacturer, product names, model references, intended purpose, accessories and proposed branding. Ask the manufacturer and UK Responsible Person to confirm that schedule in writing. A statement that they represent the factory leaves room for disagreement about a particular model or configuration.
Ask for registration evidence that can be reconciled with the schedule, and resolve discrepancies before paying a deposit. Agree how changes to models, intended purpose, branding or manufacturing arrangements will be reviewed before shipment. Use our MHRA registration guide for importers for the registration workflow.
Agree usable document access
The UK Responsible Person must keep technical documentation, the declaration of conformity and relevant certificates, including amendments and supplements, available for MHRA inspection. Ask them to confirm where these documents are held and how they obtain current versions.
Separately agree what you will receive as buyer: the declaration, applicable certificates, approved labels and instructions, and an index identifying the technical file and its custodian. Record any confidentiality limits, the request route and an agreed response time. Test that route before ordering. Do not assume access for MHRA gives you unrestricted access to the complete file.
Make communication responsibilities explicit
Record named contacts and deputies at your business, the manufacturer and the UK Responsible Person. Send your intention to import and business details through an agreed channel. Ask who will submit your importer details to MHRA and what confirmation they will return. Keep this with the order file.
MHRA guidance says the UK Responsible Person must immediately inform the manufacturer about complaints and suspected-incident reports it receives. Agree how your team will forward these, obtain acknowledgement and escalate unanswered messages. Include arrangements for document requests, sample requests and safety action. Our medical device incident guide covers handling an incident.
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Set a clear order-release decision
Keep a written record accepted by the manufacturer, UK Responsible Person and importer. Attach the device schedule, appointment confirmation, document-access arrangement and contact responsibilities. Agree who will tell you about appointment termination or replacement, and what evidence you will require before releasing further shipments.
As a purchasing control, hold the order if appointment, coverage or access remains unresolved. Ask Cambridge China Bridge's staff in China to reconcile the factory's model references and documents with the agreed schedule. Factory checks should feed into the UK Responsible Person's confirmation; they cannot establish its appointment on their own.
Frequently asked questions
How do I check a manufacturer's UK Responsible Person?
Ask for written appointment evidence and contact the UK Responsible Person independently. Confirm the manufacturer’s identity, that the appointment remains current and that your proposed devices are covered.
Does the appointment cover every factory product?
Do not assume coverage from a factory name alone. Send a schedule of models, intended purposes, accessories and branding, and obtain written confirmation against that schedule.
Can an importer demand the complete technical file?
Agree buyer access expressly. MHRA access arrangements do not establish unrestricted access for you. Specify the documents you receive, confidentiality limits and how further information will be requested.
What should happen if the UK Responsible Person changes?
Agree advance notification where possible, a document handover and fresh confirmation of appointment and device coverage. Make unresolved replacement arrangements a reason to hold further shipment release.