New post-market medical device surveillance regulations take effect in Great Britain

Medical device manufacturers with products on the market in Great Britain now need to actively track and assess the safety and performance of their products after they have been released to the market. The Medicines and Healthcare products Regulatory Agency’s (MHRA) has confirmed that new Post-Market Surveillance Regulations (PMS Regulations) are now in force following a six-month implementation period.

The PMS Regulations took effect on 16 June 2025, and apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices. The PMS Regulations apply to both newly marketed products and devices already in circulation.

The new obligations include notification requirements for incidents, and preventive and corrective actions taking place after the device is first approved for the Great Britain market. The requirements do not apply to Northern Ireland, where the EU medical device regime continues to apply under the Northern Ireland Protocol and Windsor Framework.

Overview of the changes

The PMS Regulations introduce significant post-market surveillance and vigilance requirements. Whilst they are similar to equivalent regulations in force across the European Union, they are not identical and so it is important that manufacturers with products sold in Great Britain understand the requirements:

• Enhanced PMS obligations

Manufacturers must now implement structured systems to collect, assess, and respond to post-market data, with an emphasis on proactive risk identification.

• Shorter reporting timelines

The reforms introduce shorter deadlines for reporting serious incidents and impose more rigorous obligations on manufacturers to regularly review PMS data, enhancing early detection of safety concerns.

• Trend reporting

Where repeated incidents or emerging patterns are detected, manufacturers must report these trends, even if individual events fall below the serious incident threshold.

• Increased transparency

Manufacturers may be required to submit summary PMS reports and notify users of emerging safety concerns or corrective actions.

Next steps

The new PMS Regulations forms part of the MHRA’s broader strategy to modernise the UK’s medical device regulatory framework following Brexit and its ‘roadmap’ published in 2024. Further updates are expected later this year, including wider reforms to the UKCA marking and device classification system.

How We Can help

As the regulatory landscape in the UK for medical devices is undergoing significant reforms, it is essential that manufacturers stay informed of developments under the new regulatory framework, and take early steps to align with any further guidance and obligations imposed and published by the MHRA.

CMS’ experienced team of medical device and regulatory specialists is well placed to guide manufacturers on the new PMS Regulations and support manufacturers implement the requirements. We will continue to monitor this area and report on future developments.

The MHRA’s press release can be read here and the new PMS Regulations can be found here. The MHRA’s guidance to aid manufacturers in aligning with the new obligations can be found here.