In an era driven by technological advancements, particularly in healthcare, the need to implement a robust regulatory framework is more than ever to ensure compliance and patient safety. Indeed technological disruptors such as implantable medical devices, artificial intelligence, software, and diagnostics play a crucial role in healthcare whether they facilitate early detection or prevent complex diseases. Regulatory agencies across the globe are gradually establishing regulatory frameworks surrounding such transformative technologies.
More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) issued new and robust framework to facilitate the UK’s global position in being a leader within medical technology (MedTech) while supporting patient access to MedTech and ensuring patient safety. The ‘Roadmap towards the future regulatory framework medical devices’ provides a pathway to prioritize patient safety and core elements which shall be in place by 2025. These regulations also aim to provide global harmonization adopting a more patient-centered approach and requirements for medical devices that incorporate transformative technologies.
Key milestones between 2021 and 2023
Some of the key milestones for the UK MHRA’s framework surrounding MedTech between 2021 and 2023 include the following:
- Software as Medical Devices (SaMD) and AI roadmap published
- SaMD guidance published: crafting an intended purpose; reporting adverse incidents
- Post-Market Surveillance (PMS) guidance: stakeholder focus groups
- Regulation for transition arrangements for CE-marked devices in place
- Designation of 3 new Approved Bodies
- PMS: draft legal text published by World Trade Organization
- Innovative Devices Access Pathway (IDAP) pilot launched
- SaMD guidance published: predetermined change control plans (PCCPs) for developers
- International recognition stakeholder discussions
- Regulations for in-vitro diagnostics in Northern Ireland & stakeholder awareness sessions
Planned activities for 2024-2025
Some of the key activities as part of the UK MHRA’s roadmap towards the future regulatory framework for medical devices include:
- International recognition stakeholder discussions
- PMS: Stakeholder focus groups
- Stakeholder discussions regarding:
- Scope and classification, essential requirements (including labelling & instructions for use), Approved Bodies, exempted devices
- Clinical investigations, obligations of economic operators including quality management systems and qualified persons, conformity assessments
- Unique device identification and implantable, transitional arrangements
- SaMD guidance documents:
- Good machine learning practice for medical device development mapping
- AI as Medical Device (AIaMD) development and deployment best practice
- Data-driven SaMD research, development and governance
Needless to say, the period of 2024-2025 includes a comprehensive plan for significant improvements of the framework surrounding medical devices. The aim to facilitate international recognition ensures that patients in the UK are able to access safe and effective MedTech that can support them in improving their conditions and quality of life. The UK MHRA looks forward to collaborating with international stakeholders such as the International Medical Device Regulators Forum (IDMRF) and the Global Medical Technology Alliance for successful implementation of regulatory framework.
Conclusion
The regulatory framework shall strengthen the UK MHRA’s potential in ensuring patient safety while also contributing to the MedTech landscape that supports the launch of innovative technologies and devices which will make a significant contribution to and difference in public health.
DDReg has supported its customers for product approval and life cycle management in accordance with UK MHRA regulations for 15 years. DDReg also offers regulatory services to medical device companies that are looking to bring their innovative devices to new markets. Read more about bringing innovative therapies to markets here: Fostering Medical Innovation with Expedited Review Processes