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RQMIS
UK Responsible Person Medical Devices

UK responsible person for Medical Devices /UK Medical Devices Authorized Representative

Following the UK's departure from the European Union, an EU Authorized Representative (EU AR) based in the United Kingdom (UK) is no longer recognized under EU law. As a result, manufacturers relying on a UK-based EU AR must now appoint a new EU Authorized Representative with a physical address in an EU Member State to continue placing medical devices on the EU market.

Under the UK MDR 2002 (as amended by the UK MDR 2019), which came into effect after the UK exited the EU, a new role—the UK Responsible Person (UKRP)—was established.


What are the duties of a UK Responsible Person (UKRP)/ UK Medical Devices Authorized Representative?

The UK Responsible Person (UK Medical Devices Authorized Representative) roles include:

  • Provide a United Kingdom address to the Manufacturer
  • Documentation Device related check
    • Verify the Declaration of Conformity
    • Review the Technical Documentation
    • Check where applicable that an appropriate conformity assessment exists
    • Keep the previous documentation (UKCA, Declaration of Conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years or 15 years for implantable devices)
    • Record Retention and Document Control including version controls
    • Ensure Labelling is correct and includes the details of the Authorized Representative
  • Registration in the United Kingdom
  • Communications with Health Authorities
  • Reporting

As your UKRP (UK Responsible Person/ UK Medical Devices Authorized Representative), RQMIS will:

  • Assist with Device Registrations within the United Kingdom
  • Be identified on device product labeling throughout the UK market
  • Make available to Competent Authorities (Medicines and Healthcare products Regulatory Agency (MHRA) and Notified Bodies) a current copy of the device Technical Document and/or UKCA, Declaration of Conformity for inspection, if requested
  • Assist the manufacturer and distributors with Incident and Field Safety Corrective Action reporting
  • Assist with Competent Authority communications

Need a UK Medical Devices Authorized Representative?

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