The MHRA seeks views on pre-market regulations for medical devices to improve patient access and strengthen patient safety
Responses will help shape reforms that will boost UK patients’ access to safe and innovative medical products
A consultation has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA) on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. The consultation will close on 5 January 2025.
The consultation will focus on four policy areas that have evolved significantly since the MHRA’s initial consultation to strengthen medical devices legislation was launched in 2021. These four areas, described below, are part of broader regulatory reforms that respond to recommendations set out in the Independent Medicines and Medical Devices Safety (IMMDS) review and that support the development of a regulatory framework that enables transformative technologies to reach patients as quickly and safely as possible.
The findings from this latest consultation will inform new legislation, the Pre-market Statutory Instrument, which we expect to be laid in Parliament next year. This follows the laying of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations in Parliament on 21 October 2024.
Together, these reforms will boost UK patients’ access to safe and innovative medical products, and will help the government’s efforts to eradicate health inequalities, get the NHS back on its feet and kickstart growth across the country.
The four policy areas that the MHRA is consulting on are:
1)UKCA marking
Medical devices, or their sterile pack, currently need to have a UKCA (UK Conformity Assessed) marking to be placed on the Great Britain (GB) market. The MHRA is introducing new requirements to improve device traceability by assigning devices with a Unique Device Identification (UDI), which reduce the need for a UKCA marking. The MHRA is therefore seeking views on whether to remove the requirement for physical UKCA marking.
2)International reliance
International Reliance is a mechanism whereby certain medical devices could access the GB market more quickly if they have already been approved by a comparable regulator. This was originally proposed in the government response to the 2021 consultation but since then the policy approach has developed substantially, and the MHRA now wants to seek views on a detailed policy framework for International Reliance.
3)In vitro diagnostic (IVDs) devices
IVD devices will be classified in four risk classes based on the patient and public health risk they pose. Each class has different requirements for an IVD device to gain market access, according to its risk level. The MHRA is seeking views on the regulatory requirements for Class B IVD devices to gain market access.
4)Assimilated EU law
The MHRA is seeking views on a proposal to remove the revocation date of four pieces of assimilated law so that they remain part of the statutory framework for medical devices in Great Britain until the transition to an updated medical devices regime. The four pieces of law are:
- Commission Decision 2002/364 on the common specifications for in vitro diagnostic medical devices
- Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
- Regulation (EU) No 722/2012 concerning particular requirements for medical devices manufactured utilising tissues of animal origin
- Regulation (EU) No 920/2013 on the designation and the supervision of approved bodies.
This proposal – alongside more specific transitional provisions – would ensure a smooth transition to a future regulatory framework, which aims to protect patient safety, improve access to innovative medical devices, and support innovation.