On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards the future regulatory framework for medical devices. The comprehensive plan charts the course for strong regulations governing medical devices in the UK and establishing patient-centered, proportionate requirements responsive to technological advances. With this new regulatory framework, the MHRA is prioritizing patient safety while fostering an environment conducive to the innovation of cutting-edge medical technology.
Strategic Plans for Medical Device Regulation
The roadmap outlines a strategic route for enabling regulation through a series of new Statutory Instruments (SIs), forming the backbone of the updated framework. Priority measures to safeguard patient safety will be implemented this year, with core elements of the new framework expected to be in place by 2025. The planned regulations aim for greater international harmonization. By aligning with global standards, the UK can maintain access to safe and effective medical technologies. Further, the MHRA will consider feedback from stakeholders, including patients, as the framework is rolled out.
The MHRA will also review its position on the acceptance of European Union (EU) Medical Device Regulation (MDR) and In-vitro Diagnostic Device Regulation (IVDR) CE certificates that are renewed after the strengthened future regulatory framework for medical devices is in place.
The Roadmap and Post-Market Surveillance
From a safety surveillance perspective, the roadmap reflects the MHRA’s priority of improving patient safety as part of future medical device regulations. For example, the regulatory body intends to introduce legislation in 2024 that strengthens Post-Market Surveillance requirements (PMS) ahead of the more comprehensive future regulatory landscape. These will include:
- Enhanced serious incident reporting obligations for manufacturers to support detecting safety issues sooner.
- More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices. Manufacturers will also report on the information collected from PMS activities.
- Implementation of a PMS system that collates and utilizes information from various sources.
- Detailed guidance on post-market clinical follow-up (PMCF) activities.
- Detailed guidance on reporting serious incidents and field safety corrective actions (FSCAs).
We expect the regulations to provide a detailed outline of what a PMS plan should address. For example, aligning with the EU MDR would provide economic and operational benefits to manufacturers. Aspects such as exactly what – and to what level of detail – will be included in the PMS plan should be determined using a risk-based approach. Patient involvement should also be clearly outlined within the plan.
By strengthening PMS requirements, the MHRA supports manufacturers in the earlier detection of trends and signals that may impact the safety of a medical device, ultimately improving patient safety. The proposed changes will also improve the manufacturer and the MHRA’s ability to identify issues with a medical device and, when necessary, take appropriate action to safeguard public health.
Evolving Regulatory and Technological Landscapes
The existing regulatory landscape must evolve as transformative technologies emerge, including implantable devices, healthcare AI, software, and diagnostics for early disease detection. It’s clear that the MHRA recognizes the urgency of adapting to rapidly advancing medical device technology, and ensuring patient safety remains paramount.
Veranex believes the roadmap is a much-needed step towards enhancing patient safety and fostering innovation. Learn more about our Clinical Data Services and how they can support your medical device development.