What is the main impact for manufacturers after the Brexit
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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