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What is the main impact for manufacturers after Brexit
1. There will be new regulation in the UK, UKCA, which will be mandatory by July 2025. Until that date, there is 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, UK Rep) to perform the registration.
3. The UK RP (UK, Rep) needs to be appointed by manufacturers as soon as possible. The UK RP (UK Rep) 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) becomes mandatory (July 2025), 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 name and address of the UK Responsible Person, where applicable, must be included on the product labeling or the outer packaging or the instructions for use in cases where the UKCA marking has been affixed.
7. UK Responsible Person details do not need to be included on labeling for CE-marked devices unless the device bears both the CE and UKCA markings.
For more information about the UK Medical device regulation from January 2021, click here.