The regulatory framework
The UK Regulatory Environment
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 MDR took effect in the EU and Northern Ireland from 26 May 2021.
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 – put in place the 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.
Current regulatory requirements
- All medical devices placed on the Great Britain market must be registered with the MHRA.
- Medical devices must be marked as in conformity with UK regulations, with a UKCA mark. However transitional arrangements mean that CE marked medical devices may also still be placed on the market in Great Britain.
- Manufacturers of medical devices who are not based in the UK must appoint a UK Responsible Person, who will register the devices.
- Certificates of conformity and CE marks issued by UK Notified Bodies are not valid on medical devices marketed in the EU.
- Devices placed on the market in Northern Ireland must comply with the EU MDR and be CE marked.
The Government has published regulations to extend the transition period from EU to UK regulations, these will allow certain CE marked medical devices to be placed on the Great Britain market until 2030. These regulations are expected to be approved by Parliament and come into force before 30 June 2023.
The government intends to lay new regulations on post market surveillance later in 2023.
The government intends to have in place the core of new UK medical device regulations by July 2025.
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.