The legal framework
Medical Devices Regulations 2002 – UK regulations that govern the regulation of medical devices, based on the EU Medical Devices Directive.
EU Regulation 2017/45 on Medical Devices – referred to as the MDR or EU MDR. Replaced the EU Medical Devices Directive. The transition period ends and the MDR will take full effect in the EU and Northern Ireland from 26 May 2021.
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 – put in place UK route to market following the UK’s withdrawal from the EU. It also put in place the UKCA mark, which replaces the CE mark in Great Britain.
Medicines and Medical Devices Act 2021 – gives the Government the power to make regulations to amend or add to the Medical Devices Regulations 2002, including a registry for medical devices. It also introduces new enforcement powers for the MHRA and new penalties for breaches of the regulations.
1 January 2021
- the UK is no longer part of the EU.
- The EUM MDR no longer applies in Great Britain but does apply to medical devices in Northern Ireland.
- UKCA mark can now be used – although CE marks continues to be valid on Class 1 medical devices until 2023.
- UK issued CE marks are no longer valid on medical devices marketed in the EU.
- Manufacturers can start to register medical devices marketed in the UK with the MHRA –different deadlines apply.
11 January 2021 – the UK Medicines and Medical Devices Act received Royal Assent – this gives the UK power to change its regulatory system for medicines and medical devices.
26 May 2021 – the EU MDR takes full effect and applies to all medical devices manufactured or placed on the market in the EU and in Northern Ireland
1 January 2022 – Class 1 medical device manufacturers and medical devices must be registered with the MHRA.
30 June 2023 – the CE mark will no longer be valid in Great Britain, all medical devices must be UKCA marked.
The MHRA website provides extensive guidance on the regulation of medical devices in the UK.
The EU has also published a range of guidance documents and information sheets on the EU MDR for manufacturers.