UK Responsible Person (UKRP) BREXIT By: MedicalRegs.com

Did You Know? After BREXIT, UK Will No Longer Recognize EU Authorized Representatives. AR Will Be Replaced By UK Responsible Person (UKRP). Foreign manufacturers will be required to designate a UKRP The following are some responsibilities that a UKRP are obligated to perform: Responsibilities PMS - determine whether there are any post-market surveillance responsibilities that the UK Responsible Person will be singly or jointly responsible for. Responsibilities: MHRA device registration on behalf of the foreign manufacturer. NOTE: There is a timeline for registration based on Classification after EXIT. Responsibilities Verify manufacturer's DoC, technical documentation and, if necessary, conformity assessment procedure. Responsibilities Make available the DoC, technical documents and other information that may be requested by MHRA during inspection. Responsibilities Provide relevant documentation and information to prove device conformity if requested by MHRA. Responsibilities Should MHRA request for a device sample or access to the device, forward this request to the manufacturer. Responsibilities: 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 UKRP Requirements: Provide a registered place of business in the UK where someone can be contacted and documents delivered. UKRP Requirements: Competent to carry out the responsibilities of a UK Responsible Person. Agreement/Contract Between UKRP & Manufacturer: According to Regulation 60 of the UK MDR 2002 (as amended by the UK MDR 2019) that a UKRP can be legally liable for the purposes of the Regulations. Agreement/Contract Between UKRP & Manufacturer: An agreement may include liability clause to include the UKRP in the manufacturer's liability coverage for a specified amount of time. Or, a separate liability coverage may be issued for the UKRP. Agreement/Contract Between UKRP & Manufacturer: Identify specific responsibilities and joint responsibilities that are required by the Regulations. MedicalRegs.com We have staff based in UK to perform the responsibilities of a UKRP on your behalf as a foreign manufacturer. Clarity www.MedicalRegs.com