In order to place a medical device/IVD on the GB market, manufacturers based outside of the UK must appoint a UK Responsible Person (UKRP), with a registered place of business in the UK, as defined in the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). As an experienced UKRP we can advise you on the regulatory compliance requirements of your devices.
The UK Responsible Person is required to register devices with the UK’s Regulatory Agency, the MHRA and have responsibilities which include:
- ensure that the declaration of conformity and technical documentation have been drawn up 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
- 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 we have been appointed.
From the list of responsibilities above it is clear that the role requires an excellent level of regulatory knowledge and experience, which is why Advena are your perfect choice to undertake this role for you. We have a dedicated UKRP team to care for our clients, and are founding members of the UK Responsible Person Association, an alliance of providers of UK Responsible Person Services, as defined in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) who have joined forces to promote professional conduct and competence.