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The role of the UK Responsible Person

Medical Devices and In-Vitro Diagnostics

Considering that in Great Britain medical devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), note the following:

  • In order 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 that is established in the UK;

  • In cases where the Great Britain importer is not the UK Responsible Person, the importer must inform the relevant UK Responsible Person of their intention to import a device.

The UK Responsible Person must:

  • Provide the MHRA with a list of device importers;
  • Register relevant devices with the MHRA, deadlines vary depending on devices’ type (See UK services content);
  • Where a medical device was already registered with the MHRA, it does not need to be re-registered. However, the UK Responsible Person is required to review the information held by the MHRA to ensure it remains correct in line with the above dates;
  • Act on behalf of the outside-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market;
  • Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
  • Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA;
  • In response to a request from the MHRA, the UK Responsible Person must provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device;
  • Where they have samples of the devices or access to the device, the UK Responsible Person must comply with any request from the MHRA to provide such samples or access to the device;
  • where they have neither samples of the device nor access to the device, the UK Responsible Person must communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request;
  • Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
  • Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;
If the manufacturer acts contrary to its obligations under these Regulations:
  • The UK Responsible Person must terminate the legal relationship with the manufacturer; and
  • Inform the MHRA and, if applicable, the relevant Approved Body of that termination.
The name and address of the UK Responsible Person, where applicable, must be included on product labelling where the UKCA mark has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices.

Appoint Obelis UK Ltd. as your UK RP today.

Appoint Obelis UK LTD. as your UK RP