Following on from the latest UK Government update, we are able to offer an insight into the current guidance for medical devices. After the transition period the guidance for medical devices deviates from the general UKCA guidance. Some of the main points are as follows:
- All medical devices, in vitro diagnostic devices (IVD), and custom-made devices must be registered with the MHRA from 1 January 2021.
- There is a grace period for manufacturers to register their devices with MHRA:
- 4 months: Class III and Class IIb implantable, IVD List A (30 April 2021)
- 8 months: Class IIb (non-implantable), Class IIa, IVD List B, Self-test IVDs (31 August 2021)
- 12 months: Class I devices, general IVDs (31 December 2021) – not applicable for devices already registered
- CE marking will be recognised in Great Britain (England, Scotland and Wales) until 30 June 2023. In Northern Ireland, the CE mark will continue to be allowed after 30 June 2023
- From 1 July 2023 – UKCA requirements will apply in full in GB
- UKCA mark will not be recognised in EU, EEA or Northern Ireland
- For Northern Ireland, either the CE mark or dual UK(NI) CE mark will be required
- UK Responsible Person will be required if the manufacturer is located outside the UK
- UK Approved Bodies will be designated from 1 January 2021
- Following approval from a UK Approved Body, a manufacturer will be able to affix the UKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland)
These new transitional periods will need to be supported by updated UK legislation and TÜV SÜD will provide additional information on these requirements when they are released.