Key takeaways
New Post-Market Surveillance Rules Now Apply
Manufacturers face stricter reporting and corrective action duties.
Pre-Market Reforms on the Horizon
Consultations signal changes to UKCA marking and international reliance.
Guidance Expands to AI and Cybersecurity
Stay alert to evolving rules for digital health and device safety.
In 2024, the MHRA published its ‘roadmap’ in regard to the reforms it intends to make to the UK Medical Devices Regulations 2002. We set out below a summary of the changes that are yet to come, or that have recently come into force:
New post-market surveillance regulations now in force
New post-market surveillance regulations came into force on 16 June 2025, implemented into the Medical Devices Regulations 2002 via the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2025.
The new regulations are a significant introduction of post-market surveillance (PMS) and vigilance requirements, and demonstrate the changes being made in regard to regulation of medical devices in the UK. Whilst they are similar to equivalent rules under EU medical device regulations, they are not exactly the same, so it will be important that manufacturers understand the UK requirements.
The MHRA states that the changes aim to prioritise patient safety, while still giving patients access to safe medical devices and ensuring the UK remains an attractive market for medical technology innovators.
The new regulations apply to medical devices, in vitro diagnostic devices, and active implantable medical devices.
Key new requirements are as follows, with a focus on increased reporting by manufacturers:
Enhanced data collection, specifically further details on methods for collecting PMS data;
Shorter timelines for reporting serious incidents, and more stringent requirements for manufacturers to conduct periodic reviews of PMS data, in order to support the detection of safety issues sooner; and
Clearer obligations on manufacturers to consider conduction a field safety corrective action (FSCA) to prevent or reduce the risk of a further serious incident, accompanied by detailed requirements relating to field safety notices to better target patients and users at risk.
Pre-market requirements consultation
A consultation took place between November 2024 and January 2025 in regard to proposed changes to strengthen the requirements a medical device must meet before it is placed on the market. The consultation related to four policy areas which sought to respond to recommendations set out in the Independent Medicines and Medical Devices Safety Review. The areas are as follows:
UKCA marking: as the MHRA is introducing new unique device identification that will be assigned to devices, to assist with traceability, the MHRA consulted on whether this would reduce the need for physical UKCA marking.
International reliance: this relates to a proposal to allow medical devices to be placed on the market in Great Britain more easily if they are authorised in a comparable jurisdiction.
In vitro diagnostic devices: this is a proposal to introduce different risk classes for IVD devices, as is already the case with medical devices, seeking views on the regulatory requirements for Class B IVD devices in particular.
Assimilated EU law: the suggestion here is that four pieces of EU legislation which are already in force but are set to be revoked will instead remain in force going forwards as part of the statutory framework, until there is a further update.
An insight into the proposed legislation should be published by the end of the summer, and implementation of new legislation is anticipated to be in early 2026.
Policy development and new guidance
Lastly, the roadmap references proposed policy development, as well as the publication of new guidance.
The statement of policy intent in regard to the international recognition of medical devices has been published, and can be accessed here. Guidance for exceptional use authorisations has been updated (here), which importantly permits medical devices to be sold without UKCA marking if it is needed to protect a patient’s health and if there is no alternative.
There has also been new guidance on artificial intelligence as a medical device (here), as well as guidance on digital mental health tech and how to determine the appropriate regulatory qualification and classification (here).
An IVD roadmap and further guidance on cybersecurity (in regard to software as a medical device) are to be published in due course.
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Manufacturers should ensure that they stay up to date and are proactive in considering their obligations arising under new legislation, and consider any further guidance published by the MHRA on this. In addition, distributors of such devices may be required to work with manufacturers in assisting them to comply with such obligations.
