UK Announces Roadmap for New Medical Technology Regulations

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid out the final roadmap for 2024 to create a comprehensive set of regulations for medical devices and technology, bringing the UK one step closer to finalizing its regulatory framework after leaving the EU.

Technologies such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease, will all be subject to the new regulatory framework. The roadmap is the culmination of public input and stakeholder discussions begun in 2021 and outlines how the agency will continue to work with stakeholders to get feedback on the wide-ranging reforms.

The framework will be in place by 2025, the agency says, and will include guidance on labeling, instructions for use, unique device identifiers, information on aligning device classification with international protocols, new requirements for quality management systems, technical documentation and clinical investigations and a plan for ensuring the international harmonization of technology.

To read the whole story, click here to subscribe.

Related Topics