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The MHRA have published a roadmap towards the future regulatory framework for medical devices. This sets out the relevant timelines into 2025. The roadmap intends to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.

According to the timelines, MHRA intends to run stakeholder discussions on the future core regulations during the first half of 2024. This is to give an early sight of the detailed policy. These core elements of the future regulatory framework are intended to be in place by 2025. The core elements will cover different aspects including, but not limited to, classification of several types of devices, UDI requirements, international recognition and requirements for economic operators. More information on this can be found here.

This is a significant step taken by the MHRA in unveiling this comprehensive roadmap. BIVDA are fully committed to supporting the work taking place to shape the future of IVD regulation in the UK. If you have any questions or feedback on this topic, please send them to