Why need a UK Responsible Person?
During the Christmas break, the UK government closed the deal with the EU regarding Brexit. The lengthy paperwork that goes along with these trade deals is now in review. Some conclusions can be drawn about the impact on medical devices and IVD. The trade deal does not mention much regarding medical devices and IVD specifically and the trade deal will not change the process that the MHRA already started.
The overall conclusion is that the registration of medical devices/IVDs in the Great Britain market will continue in the way the MHRA already started and where MHRA guidance is available.
Are you located outside of Great Britain and would you like to market your devices onto the Great Britain market (England, Wales and Scotland)? You will need to appoint a UK Responsible Person that is established in the UK. Manufacturers should aim to appoint their UK Responsible Persons as soon as possible, where required. The UK Responsible Person must then register relevant devices with the MHRA in line with the above grace periods depending on the device class.
Let’s summarize the main impact for manufacturers
1. There will be new regulation in the UK, UKCA, which will be mandatory by June 2023. Until that date, we have a grace period and the EU CE mark will be accepted.
2. Devices/IVDs that will be placed on the UK market will need to be registered with the MHRA. Manufacturers need to appoint a UK Responsible Person (UK RP) to perform the registration.
3. The UK RP needs to be appointed by manufacturers as soon as possible. The UK RP needs to have a UK entity and address.
4. Registration deadlines depend on the classification of the devices/IVDs:
- May 1st, 2021: Class IIIs and Class IIb implantables, all active implantable medical devices and Annex II List A IVDs
- September 1st, 2021: Class IIb non-implantable, all Class IIa devices, IVD List B, and Self-test IVDs
- January 1st, 2022: Class I devices and General IVDs.
5. Until the new UK regulation (UKCA) will be mandatory (June 2023), devices/IVDs that are in compliance with the following directives/regulations can be placed on the UK market: MDD, MDR, IVD and IVDR.
6. The UK RP address does not have to appear on the labelling, only when you apply for the UKCA mark.
7. Labeling does not have to change until June 2023. When the manufacturer starts with compliance to the UKCA mark, the label must change to be in compliance.
For more information about the UK Medical device regulation from January 2021, click here.
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Role of a UK Responsible Person
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
Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given 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 for which they have been designated.
Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.