Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, highlights a new UK Government agency consultation on medical devices regulation.
The UK Government’s, Medicines and Healthcare products Regulatory Agency [MHRA] has launched a new consultation on forthcoming regulations on routes to market for medical devices and in vitro diagnostic devices.
The Parliamentary Under Secretary for Patient Safety, Baroness Gillian Merron, says the proposals are a ‘small but important part of a wider set of reforms to the regulatory framework for medical devices and, furthermore, this government’s efforts to eradicate health inequalities, get the NHS back on its feet and kickstart growth across the country’.
The MHRA is consulting on four areas:
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.
International reliance:
International Reliance is a mechanism through which some medical devices could access the GB market more quickly if they have already been approved by a comparable regulator in another country.
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 IVDs, which covers IVDs for lower risk self-testing, such as pregnancy tests, fertility tests, and cholesterol tests.
Assimilated EU law: remove the revocation date of four pieces of law originating from the European Union so that they remain in place until the transition to an updated medical devices regime:
- 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.
In future, the government intends to consult further on further legislative measures, such as the expansion of digital labelling and a solution to health institution exemptions that is fit for today’s NHS, where care is increasingly delivered in the community.
As the proposed regulations will help shape the regulatory framework for medical device, the sector should engage constructively with the consultation. The consultation is open for input until 5th January 2025.
Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com