UKRP, UK Market Access and MHRA Registration
The United Kingdom (UK) requires medical device manufacturers based outside of the UK to appoint a UK Responsible Person who has a registered premises in the UK to act on behalf of the medical device manufacturer, for the purposes of registering those manufacturers medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) under the UK Medical Device Regulations 2002 (as amended) (UK MDR 2002).
The responsibilities of the UK Responsible Person are set out in the UK MDR 2002. In summary, in addition to the above registration requirements, the UK Responsible Person must:
- 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, 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, 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, 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:
- 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 or EU responsible person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed.