MHRA Publishes Government Response on Medical Device Regulation

The MHRA has released the Government's response to its 2024 public consultation on future routes to market for medical devices in Great Britain.

The reforms aim to modernise regulation, enhance patient access to innovative technologies, and support med tech industry growth.

Key Highlights:

International Reliance Routes: New streamlined pathways will allow certain medical devices approved in Australia, Canada, and the US to enter the GB market more quickly.
Focus on Innovation: The UKCA route will prioritise first-in-market and innovative technologies, including AI as a medical device.
CE Mark Recognition: A consultation is planned for later in 2025 on indefinitely recognising CE-marked devices, extending beyond the current transitional deadlines (2028/2030).
UKCA Marking Changes: Physical UKCA markings will be removed once Unique Device Identification (UDI) is implemented, reducing burdens on manufacturers while improving traceability.
IVD Regulation: Class B in vitro diagnostic devices will follow a risk-proportionate approach, requiring self-declaration and ISO 13485 certification.
Post-Market Surveillance: Enhanced requirements will improve patient safety and monitoring of devices already on the market.

These reforms align closely with what has been set out in the UK’s Life Sciences Sector Plan, Industrial Strategy, and 10-Year Health Plan, aiming to reduce regulatory duplication and accelerate access to technologies.

You can see the full consultation response here. For more information or to discuss these changes, please email: [email protected].

Rachel Kennedy

Programme Manager Health and Social Care, techUK

Rachel joined techUK in December 2024, as a Programme Manager in the Health and Social Care team.

Prior to this, Rachel worked at a specialist health and social care public affairs agency, working with a range of organisations and trade bodies across the medical technology, pharmaceutical, digital health and social care sectors. As well as this, Rachel was part of the Secretariat for a number of health and care related All-Party Parliamentary Groups.

Rachel has a Masters in Global Governance and Diplomacy from the University of Leeds, as well as a first-class honours in Politics BA from Newcastle University.

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