The MHRA has announced key new steps to enable patients to access the latest medical devices available in Europe and other developed countries.
In addition to enhancing patient access to medical devices, the proposal will drive the industrial growth of MED technology by reducing the overlapping regulatory costs faced by manufacturers.
Instead, they will concentrate the Domestic Recognition Route (UKCA) on innovative technologies in the market, including AI as medical devices.
MHRA is currently announcing the UK government’s response to public consultations on future routes for UK medical devices, designed to modernize regulations and improve patient access to the latest and innovative technologies.
“The Minister of Science is a great opportunity to see the world,” said Lord Patrick Balance.
“MHRA can better target resources by enabling fast, informed and wise decision-making through international trust,” he said, “focusing on regulatory activities and scientific advice that drive the development of innovative new medical products.”
Faster access to medical devices from trusted regulators
To respond directly to stakeholder feedback, MHRA has also announced its intention to consult later this year about indefinite recognition of CE-marked medical devices.
Additionally, new international trust routes will be introduced to promote rapid access to medical devices from trusted regulators in Australia, Canada and the US.
This allows eligible products to follow a streamlined pathway to the market, thereby bringing the latest technology to patients more quickly.
MHRA supports removing the physical UKCA mark requirements for products and packaging once unique device identification (UDI) requirements are enforced.
This reduces barriers to market intrusion and enhances traceability and safety monitoring.
These measures reflect the UK’s Life Science Sector Plan and Industrial Strategy, as well as the government’s commitment to the UK’s 10-year health plan, reducing unfair barriers to market invasion and providing transformative technology to patients more rapidly.
Overview of consultation response
The MHRA’s 2024 public consultation on medical device regulations focused on the following areas: international trust, UKCA marking, and regulation of in vitro diagnostic (IVD) devices:
Here are some tips to advance:
The international reliance route allows certain medical devices with approval or certification from trusted regulatory authorities in Australia (TGA), Canada (Health Canada), and the US (FDA) to follow a streamlined route to the UK market. The government will discuss later this year on proposals to recognize indefinitely CE-marked medical devices that will remain recognized in GB under existing transition agreements until June 30, 2028 or 2030. Physical UKCA marking requirements are removed when unique device identification (UDI) is introduced. Class B IVD devices are subject to a more risk-proportional approach, requiring manufacturers to self-determinedly comply with Medical Device Regulations 2002 and to maintain ISO 13485 Quality Management System Certification.
Supporting government health policy reforms
These measures reflect the UK’s Life Science Sector Plan and Industrial Strategy, as well as the government’s commitment to the UK’s 10-year health plan, reducing unfair barriers to market invasion and providing transformative technology to patients more rapidly.
Today’s announcement forms part of a broader regulatory reform program for medical devices, with improved patient safety through new post-market surveillance requirements, the creation of streamlined, risk predictive routes to speed up market input for products already being evaluated in the comparative area, and refocusing UKCA domestic routes of innovative technologies, including AI.
“Our 10-year health plan seizes the opportunities new technologies, medicines and innovations offer better care for our patients, whether they are at home or overseas.”
“It makes perfect sense that medical devices that have been approved for use in countries where safety regulations we trust can also be used here, without delaying the bureaucracy that could benefit NHS patients.”
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