MHRA opens consultation on future UK Medical Devices Regulations

The Medicines and Healthcare products Regulatory Agency (MHRA) just launched a consultation on the future UK regulatory framework for medical devices (UK MDR). The deadline for responses is 5 January 2025.

This consultation concerns proposals for pre-market provisions for medical devices and IVDs. In October 2024, the UK already presented revised post-market surveillance requirements for the Great Britain market.

Consultation areas on UK MDR

The MHRA is inviting members of the public to submit their views on updates to the UK legislative framework for medical devices placed on the market in Great Britain. The four policy areas subject to the consultation are:

• UKCA marking – The UK government is assessing whether to remove the requirement for devices which undergo the UK conformity assessment process to bear a UKCA marking on their labels.
• International reliance – Currently, medical devices need to bear a UKCA or a CE marking from the European Union to be placed on the Great Britain market. CE marking is accepted only up until 2030, depending on the class of the device. The MHRA proposal is to seek for other international reliance routes for medical devices. Specifically, only certain UK requirements could apply to medical devices with a certified Quality Management System (QMS) and already compliant with legislation in Australia, Canada, USA or EU. For such devices, the proposal envisages that a UK Approved Body will perform a review of a device, except for Class I MDR and Class A IVDR.
• In vitro diagnostic devices – The MHRA is assessing whether the regulatory requirements for IVDs are appropriate and proportionate to their risk class. In particular, the consultation addresses provisions for class B IVDs.
• Assimilated EU law – The UK government is seeking views on a proposal to keep certain EU assimilated laws as part of the statutory framework for medical devices in Great Britain until an updated medical devices regime. The assimilated laws 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.

Do you have questions on compliance of medical devices and IVDs in the UK? Contact us here.