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MHRA Roadmap

By January 10, 2024No Comments

A new MedTech roadmap published by the MHRA

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

Dr Laura Squire, the MHRA’s MedTech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access, said:

“We are pleased to begin this new year by setting out a plan for significant improvements to the regulatory framework for medical devices over the next two years. The new framework will strengthen the MHRA’s power to act to keep patients safe, at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to public health.

“The roadmap sets out how we will work with stakeholders as the process moves forward, giving them early sight of what is to come and giving us feedback about the guidance they will need, to ensure the successful implementation of these wide-ranging reforms.”

Helen Dent, BIVDA’s Chief Executive, said:

“BIVDA (British In Vitro Diagnostics Association) welcomes this approach by the MHRA to charting the roadmap for new UK medical device regulations. Patient safety and accessibility are essential, and this proposed timetable of measures reflects a positive step towards achieving these goals. We look forward to continuing to collaborate closely with the MHRA, industry stakeholders and our members to ensure the successful implementation of these regulations.”

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 Regulatory@bivda.org.uk.

Dawn