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In addition to device registration with MHRA, the UK Responsible Person has the following obligations:

  • Ensure that the declaration of conformity and technical documentation have been drawn up.

  • Keep available a copy of the technical documentation, a copy of the declaration of conformity for inspection by the MHRA.

  • In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.

  • Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.

  • 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 designated.

  • Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.

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