The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”). It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary:
- From 1 January 2021, different rules will apply to medical devices placed on the market in Great Britain (e., England, Wales and Scotland) and those placed on the market in Northern Ireland and elsewhere in the EEA.
- Manufacturers may continue to use the CE-mark and it will be recognised in Great Britain until 30 June 2023.
- Manufactures may continue to rely on EEA Notified Body certificates until 30 June 2023 for products placed on the market in Great Britain.
- There will be a new route for conformity assessment of medical devices placed on the market in Great Britain from 1 January 2021.
- All medical devices and in vitro diagnostic medical devices (“IVDs”) placed on the market in the UK have to be registered with the MHRA. There will be certain grace periods for registering existing devices.
- Manufacturers based outside the UK will need to appoint a UK Responsible Person.