On January 9, The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced its plan for medical device regulation. The ‘roadmap’ for new regulations sets out a route to deliver new regulations via a series of new Statutory Instruments (SIs). The agency will put priority measures to protect patient safety into place this year, with core elements of the new framework intended to be in place by 2025.
In its announcement, the agency stated that the new regulations will “put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, while enhancing the UK’s position as a world-leading environment for medical technology innovators.”
In addition to creating a new regulatory framework for transformative technologies such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease, the planned regulations are also designed to deliver greater international harmonization, with more patient-centered requirements for medical devices which are responsive to technological advances.
“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,” said Dr. Laura Squire, Med Tech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access at MHRA. “The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health. The roadmap sets out how we will work with stakeholders, including patients, as the process moves forward, giving early sight of what is to come and giving us feedback about the guidance they will need to ensure the successful implementation of these wide-ranging UK reforms.”
The UK government intends to introduce legislation in 2024 that will bring into force strengthened Post-Market Surveillance requirements (PMS) in Great Britain (GB) ahead of the wider future regulatory framework. The regulations will be based on the World Trade Organisation’s draft Post-market Surveillance Requirements Statutory Instrument (PMS SI) and feedback received on the draft requirements. The new PMS requirements are expected to be announced in the first part of 2024 and come into force towards the end of 2024.
During the first half of 2024, MHRA plans to hold stakeholder discussions on future core regulations that will:
- Introduce several improvements for implantable medical devices; up-classifying them which will result in more stringent pre and post market requirements and requiring manufacturers to provide implant cards to enable patients to know which device they have had implanted.
- Ensure devices have a unique device identifier (UDI).
- Change the classification of several types of devices, specifically increasing the class of certain software as a medical device and aligning IVD classifications with those of the International Medical Device Regulators Forum.
- Strengthen the requirements for quality management systems and technical documentation.
- Introduce a framework for international recognition, enabling swifter access for devices already approved by comparable regulators as well as for those who have Medical Device Single Audit Program (MDSAP) certificates.
- Include new requirements for exempt in-house manufactured devices and custom-made devices.
- Include new requirements for the claims manufacturers can make about their medical devices requiring them to align with their statement of intended purpose.
- Include new requirements for clinical investigations.
- Bring the essential requirements for medical devices being placed on the market in GB into greater alignment with those of the EU. This will include cybersecurity requirements for software as a medical device including for artificial intelligence.
- Clarify the requirements for conformity assessments and approved bodies.
- Clarify the requirements for economic operators; manufacturers, importers and distributors, and introduce a requirement to have a Person Qualified in Regulatory Compliance.
A visual timeline of the MHRA roadmap can be found here.