The Medicines and Healthcare products Regulatory Agency (MHRA) has set out a regulatory roadmap to enable safe access to medical technology, including artificial intelligence (AI) and diagnostics.

The Roadmap Towards the Future Regulatory Framework for Medical Devices will support the development of new regulations that will prioritise patient safety and help ensure individuals continue to have access to the devices they need without delay, while enhancing the UK’s position as "a world-leading environment for medical technology innovators," the MHRA said.

The roadmap is also set to offer "significant new opportunities for patients and healthcare” by enhancing the UK’s ability to benefit from advancing medical technology such as implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease.

Dr Laura Squire, the MHRA’s MedTech regulatory reform lead and chief officer of healthcare, quality and access, said: "Today’s exciting medical technology advances offer important new opportunities for patient care and improvements to healthcare delivery.

"We are therefore delighted to begin this new year by setting out a comprehensive plan for significant improvements to the regulatory framework for medical devices over the next two years."

Squire added that the roadmap sets out how the agency will work with stakeholders to gain feedback on the guidance they will need and ensure the successful implementation of the "wide-ranging UK reforms”.

Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025.

The rapid growth of medical technology has meant that governments and regulatory bodies have had to direct efforts to support its safe integration into the healthcare sector.

In October of last year, the US Food and Drug Administration set up a new advisory committee to provide expertise on the benefits, risks and clinical outcomes associated with the use of digital health technologies.

In the same month, the World Health Organization released a new publication listing key regulatory considerations on AI for health, with the organisation emphasising the importance of establishing the safety and effectiveness of AI systems.

More recently, the European Medicines Agency and the Heads of Medicines Agencies published a workplan to guide the use of AI in medicines regulation until 2028.

https://www.pmlive.com/pharma_news/mhra_sets_out_regulatory_roadmap_to_support_safe_access_to_medical_technology_1506182