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MHRA Consultation on Pre-Market Regulations Involving Medical Devices

16th December 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a crucial consultation aimed at reshaping pre-market regulations for medical devices in Great Britain. Launched on November 14, 2024, this consultation invites feedback on proposed regulatory changes, which are expected to bolster patient access to safe, innovative medical technologies. Running until January 5, 2025, this consultation will help inform upcoming legislation that supports advancements laid out in the Independent Medicines and Medical Devices Safety (IMMDS) review.

The MHRA, a pivotal agency in the healthcare sector, is focused on enhancing the UK medical device landscape following significant developments since a similar 2021 consultation. A major element under review is the requirement for UKCA (UK Conformity Assessed) markings, where the agency considers replacing physical markings with Unique Device Identifications (UDI) for better traceability. Furthermore, the MHRA’s consultation explores “International Reliance” – a framework allowing quicker market access for devices approved by comparable foreign regulators, signalling a more globally integrated approach. Additionally, the classification of In Vitro Diagnostic (IVD) devices by risk level is under scrutiny, with particular focus on Class B requirements. Finally, the agency is looking at retaining certain aspects of EU law in the UK regulatory framework during its transition to a new regime.

This consultation signifies a major step by the MHRA in improving regulatory practices that could lead to quicker access to innovative medical solutions for UK patients. Such reforms are projected to address health inequalities and invigorate NHS resources, ultimately fostering growth and effectiveness in the healthcare sector. Stakeholders’ views on these proposed changes will be instrumental in shaping future healthcare regulations, making participation vital for ongoing industry advancement.

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