The UK Medicines and Healthcare products Regulatory Agency (MHRA) has revealed a roadmap for medical device regulation, aiming to prioritize patient safety and establish a new framework by 2025. As released on January 9th, 2024, the agency plans to implement priority measures this year, focusing on transformative technologies like implantable devices, healthcare AI, software, and early disease detection diagnostics. The regulations aim to enhance international harmonization and introduce patient-centered requirements responsive to technological advancements. The roadmap also includes provisions for international recognition, cybersecurity requirements for AI in medical devices, and clarification of conformity assessments and economic operator requirements.
Dr. Laura Squire, Med Tech Regulatory Reform Lead at MHRA, emphasized the importance of the new framework in ensuring patient safety while fostering an environment conducive to innovative healthcare products. Dr. Squire states, “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 enact legislation in 2024, strengthening Post-Market Surveillance requirements based on the World Trade Organization's draft Post-Market Surveillance Requirements Statutory Instrument (PMS SI) in addition to feedback received on the draft requirements.
See the bulleted list below for some of the intended discussions on future regulations by MHRA stakeholders that will take place in early 2024:
- 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 and more!
Read more from MHRA in the Reference section below for a deeper dive into these stakeholder discussions and future regulations.
Overall, the MHRA aims to create a comprehensive plan for significant improvements to the regulatory framework, involving stakeholders and providing early insights into upcoming changes. The timeline visualizes the phased implementation of these reforms.
Visit the link below from MHRA to see a visual of this roadmap:
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Ava Carr – Content Creator