The UK government is preparing to introduce a second major update to the regulatory framework for medical devices, with new pre-market requirements expected to come into effect in 2026.
These changes form part of a broader reform effort that has been underway for several years. In 2022, the UK government published its Government response to consultation on the future regulation of medical devices in the United Kingdom, setting out a phased approach to overhaul the UK Medical Devices Regulations (UK MDR).
In December 2024, the MHRA published a Medical Devices Regulatory Reform roadmap providing an update on the intended timelines for implementing future UK medical device regulations. This roadmap is structured around four key areas:
- Post-market surveillance (PMS) requirements
- Pre-market requirements
- Broader policy development (including an IVD roadmap and exceptional use authorisations)
- Software, including AI and digital mental health products.
Post-market amendment
On the 16th of December 2024 the UK Government published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
This legislation, which comes into effect on 16th June 2025, introduces strengthened PMS requirements for medical device manufacturers. For an in-depth overview of the changes, see our dedicated article on this topic.
This legislation marks the first formal update to the UK MDR.
Pre-market amendment
Following the PMS update to the UK MDR, the UK government has consulted on a second major update - Routes to market and in vitro diagnostic devices - which aims to implement new regulations for pre-market requirements.
In a recent House of Lords motion, Baroness Merron mentioned that this major update is expected to come into force in 2026.
Many of the changes introduced with this legislative amendment will have the effect of bringing the UK MDR in closer alignment with the EU MDR. Below we highlight some of the changes that we might expect to see:
- Up-classification of Software as a Medical Device (SaMD) and implantable medical devices, resulting in stricter requirements for both device categories
- Introduction of a framework for international recognition
- Alignment of the UK MDR Essential Requirements (ERs) with the EU MDR General
- Safety and Performance Requirements (GSPRs)
- Updated classification rules for In-Vitro Diagnostic (IVD) medical devices
- Introduction of implant cards and Unique Device Identifiers (UDI)
- Strengthened technical documentation requirements
Conclusion
The forthcoming updates to the UK Medical Devices Regulations represent a significant shift in the country’s regulatory landscape, aiming to enhance patient safety, foster innovation, and improve international alignment. While manufacturers already compliant with the EU MDR will find many of the anticipated changes familiar, UK-based manufacturers who have not yet adapted to similar frameworks should begin preparations. Early planning and a thorough understanding of the new requirements will be essential to maintaining market access and avoiding disruption. With the new pre-market requirements expected to come into force in 2026, the time to act is now.
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