The MHRA has released an update on the registration of medical devices in the UK, specifying the requirements for domestic and international manufacturers. The MHRA reinforces the need for compliance with the new surveillance and registration requirements, ensuring that medical devices and IVDs meet UK regulatory requirements before they are placed on the market.

The MHRA has confirmed that four key EU regulations for the regulation of medical devices and in vitro diagnostic medical devices (IVDs) will be retained in the UK after May 26, 2025. The decision covers rules on common technical specifications, electronic instructions for medical devices, the use of tissues of animal origin and the supervision of approved bodies. In addition, the MHRA plans to update the legislation, replacing the reference to Regulation (EU) 207/2012 with the more recent Implementing Regulation (EU) 2021/2226. Meanwhile, further changes are expected with the upcoming "Pre-Market" legislation, which could impact the requirements for high-risk IVDs and remove temporary approvals for COVID-19 testing. Manufacturers and companies in the sector should follow these updates to ensure regulatory compliance in the UK market.

Implementing Regulation (EU) 2025/117 introduces detailed rules for joint scientific consultations under the HTA Regulation, promoting collaboration between medical device and IVD developers, clinical experts, patients, and stakeholders. This new regulatory framework, in force since January 2025, reinforces technological innovation by providing clear guidance on clinical evidence requirements, facilitating the joint clinical assessment process. Collaboration with the European Medicines Agency (EMA) is another highlight, ensuring synchronised consultations with expert panel reviews. This regulation represents an important step towards improving regulatory compliance and supporting the introduction of innovative health technologies into the European Union market.