Questions regarding the UK Responsible Person and medical device/IVD registration with the MHRA

UK Responsible Person / UK authorized representative

1. What are the timelines for appointing a UK RP and for registration of medical devices and IVDs? The MHRA guidance states that a manufacturer must appoint a UK RP as soon as possible. The MHRA has provided a grace period for the registration of medical devices and IVDs in order to allow time for compliance with the new registration process. Check the due dates for register your medical device in UK. Medical Device Registrations in UK

2. Who can provide the UK Responsible Person / UK authorized representative? RQMIS experts consultants can provide the UK Responsible Person / UK authorized representative services for your medical device in the UK. Check out our services: Find the Right Authorized Representative for your Medical Devices

3. Can the UK Responsible Person (UKRP) provide support to the technical documentation? The UK Responsible Person will need to review the technical documentation before submitting and register the medical device in the MHRA database. It can be a hard copy or e-copy, or a link to the manufacturer’s documentation system. RQMIS medical device expert consultants can help the manufacturer to comply with the UK medical device regulation. Also, RQMIS provides UK Responsible Person / UK authorized representative services for UK. RQMIS acting as UK Responsible Person / UK authorized representative will provide support in all the areas related to the registration of the medical device in the UK.

4. Which are the changes for UK medical devices Labeling and Coding? The labeling and packaging of devices placed on the Great Britain market based on the EU MDD/IVDD or EU MDR/IVDR do not have to change until 30 June 2023. This means that the current labeling and packaging including the CE mark remain valid. The name and address of the UK RP do not need to be on the label and packaging until 30 June 2023.

5. The medical device manufacturer, should use the CE Mark or the UKCA? Devices can have both the CE mark as well as the UKCA mark present on the labeling prior to 1 July 2023, and dual marking will continue to be accepted on the Great Britain market after 1 July 2023.

6. Will the MHRA issue a list of recognized GMDN codes for medical device registration in the UK and is the GMDN code compulsory even it is not mandatory for the EU medical device registration? It is compulsory to list the GMDN code during the UK medical device registration process. Without the GMDN code the registration of the device cannot be completed. If a manufacturer does not have a GMND code, our consultants experts can support the medical device manufacturer in identifying the appropriate GMDN code. The MHRA has not listed an overview of recognized GMDN codes for the public as this would be against the GMDN Agency policies. During the medical device registration process of a device into the UK medical device database, all GMDN codes can be searched for. This means that the list of GMDN codes in the UK database is always up to date with the GMDN Agency.