MHRA has made it mandatory to appoint a UKRP if the manufacturer of the medical device is not based in the UK. The UK Responsible person services include registering the medical devices with MHRA on behalf of the manufacturer, ensuring conformity to be available for inspection, responding to any queries from MHRA and carrying out Post Marketing Surveillance (PMS) activities.
Role of UKRP
The appointed United Kingdom Representative should register device products with the MHRA.
Eligibility for being a UKRP
Any third-party entity or an importer or distributor can act as a UK Responsible Person on a foreign manufacturer’s behalf.
The timeline for appointing a UKRP is in line with the timeline for getting the device registered with MHRA i.e., 4 months, 8 months and 12 months for different classes of devices.