The Medicines and Healthcare products Regulatory Agency (MHRA) is conducting a consultation on the future regulatory framework for medical devices in the UK (UK MD). The consultation deadline is 5 January 2025.
The current consultation focuses on proposed changes to pre-market provisions for medical devices and in vitro diagnostic devices (IVDs).
Key areas under review include:
- UKCA Marking: The UK government is considering removing the requirement for medical devices that undergo the UK conformity assessment process to display a UKCA marking on their labels.
- International Reliance: The consultation explores allowing reliance on international routes for device approvals. This includes CE marking from the European Union (until 2030) and potential recognition of approvals from other countries, such as Australia, the USA, and Canada. For most devices, a UK Approved Body would still perform a review, except for Class I MDR and Class A IVDR devices.
- In Vitro Diagnostic Devices (IVDs): The MHRA is evaluating whether the current regulatory requirements for IVDs are appropriate and proportionate to their risk classification, focusing particularly on Class B IVDs.
- Assimilated EU Law: The statutory framework for medical devices in Great Britain incorporates elements of EU law, such as common specifications, rules for devices containing materials of animal origin, and the designation process for Approved Bodies. The consultation seeks feedback on refining and rephrasing these regulations.
These proposals aim to ensure the UK regulatory framework remains robust, efficient, and aligned with international best practices.