To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person.
The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.
Obligations of UK Responsible Person (UKRP)
1. Declaration of Conformity and Technical Documentation
Verify that the declaration of conformity and technical documentation are prepared and, if applicable, that the manufacturer has followed the appropriate conformity assessment procedure.
2. Maintain Technical and Compliance Records
Keep a copy of the technical documentation, declaration of conformity, and any relevant certificates (including amendments and supplements) accessible for inspection by the MHRA.
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3. Provide Compliance Documentation
Respond promptly to MHRA requests by providing all necessary information and documentation to prove a device’s conformity.
4. Device Samples and Access
If samples or access to devices are available, comply with MHRA requests to provide them. If not available, communicate MHRA requests to the manufacturer and relay the manufacturer’s response back to the MHRA.
5. Collaborate on Safety Measures
Work with the MHRA on preventive or corrective measures to eliminate or mitigate risks associated with devices.
6. Report Complaints and Incidents
Notify the manufacturer immediately of complaints or reports from healthcare professionals, patients, and users about suspected device incidents.
7. Action Against Non-Compliance
If the manufacturer fails to meet regulatory obligations:
- Terminate the legal relationship with the manufacturer.
- Notify the MHRA and, if applicable, the relevant Approved Body about the termination.
The UK Responsible Person’s name and address must be included on product labelling or packaging, or instructions for use with UKCA markings. CE marked devices don’t need details unless they have both CE and UKCA markings.
