The MHRA has published a two-year workplan for the development of new regulations for medical devices in the UK.
This roadmap sets out the agency’s key objectives which are to prioritise patient safety and facilitate access to innovative medical technologies, including enhancing patients in the UK’s ability to benefit from rapidly advancing medical technology.
The regulations will be delivered through four Statutory Instruments. They include arrangements to ease the transition to future frameworks for devices, strengthening patient safety by upping post-market surveillance (PMS) requirements, develop a mechanism for stakeholder discussion on future core regulations, and implementation of the regulations.
New regulations will include the creation of a dedicated framework for emerging technologies including implantable devices and healthcare artificial intelligence and software.
PMS requirements will be the first change to be put in place with core elements of the new framework expected by 2025.
“Today’s exciting medical technology advances offer important new opportunities for patient care and improvements to healthcare delivery,” said Dr Laura Squire, the MHRA’s MedTech Regulatory Reform Lead and Chief Officer for Healthcare, Quality and Access.
“We are therefore delighted to begin the new year by setting out a comprehensive plan for significant improvements to the regulatory framework for medical devices over the next two years.”
