On March 5, 2024, the Medicines and Healthcare Products Regulatory Agency (MHRA) hosted the MedTech Regulatory Reform webinar, shedding light on the forthcoming regulations governing medical devices and IVDs in the UK. This virtual event delved into the scope, classification, and essential requirements of the future regulatory framework.
In January 2024, the UK unveiled an updated roadmap outlining the path toward the future regulatory framework for medical devices. However, the outcome of next year’s general elections could potentially impact this trajectory.
Key Highlights from the MHRA MedTech webinar:
The future regulatory framework will consist of three statutory instruments; Post Market Surveillance, Future Core Regulation, and Future Enhancement Regulation, with a primary focus on enhancing patient safety, aligning with international best practices, and fostering a conducive market environment for medtech companies.
Additional insights from the webinar included:
A comprehensive definition of software as a medical device.
Incorporation of products without a medical purpose into the Future Enhancement Regulation, such as dermal fillers.
Alignment of future UK regulations with the EU MDR for device classification, with software medical devices following IMDRF risk categorisation and IVDs aligned with IMDRF principles with some UK-specific adaptations.
Harmonisation of essential requirements with EU MDR and IVDR General Product Safety Requirements, tailored to the UK context.
Inclusion of critical information on device labels, including clinical performance, storage, shelf-life, and biosafety data.
Introduction of a Unique Device Identification (UDI) system, particularly for Class III and implantable devices, along with guidelines for reporting serious incidents.
Exploration of electronic Instructions for Use (IFU) for certain devices, particularly those intended for professional use.
The future core regulations will enable greater international collaboration and practices, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.
Please note; the regulatory framework of medical devices is subject to many updates and changes.
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