The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined its strategy for the development of fresh regulations governing medical devices in the UK. Emphasising patient safety as the top priority, the government aims to ensure uninterrupted access to necessary devices while bolstering the UK’s standing as a global hub for medical technology innovation.

This new regulatory “roadmap” aims to harness the potential of rapidly evolving medical technology, ushering in new prospects for patients and healthcare providers alike. The MHRA’s plan involves implementing enabling regulation through a series of new Statutory Instruments (SIs), with a focus on prioritising measures to safeguard patient safety this year. Key components of the framework are slated for completion by 2025.

The proposed regulations also seek to foster international alignment, incorporating patient-centred, proportionate requirements that adapt to technological advancements. Dr Laura Squire, the MHRA’s lead for medtech regulatory reform and chief officer for healthcare, quality, and access, raised the importance of these changes.

She highlighted the potential of emerging medical technologies to reform patient care and healthcare delivery, underlining the MHRA’s commitment to enhancing the regulatory landscape to ensure patient safety and encourage innovation.

Peter Ellingworth, Chief Executive of ABHI (Association of British HealthTech Industries), underscored the significance of international recognition in maintaining access to safe and effective healthtech for UK patients. He hailed the MHRA’s roadmap as a crucial step towards fostering innovation and growth within the UK while supporting the expansion of domestic businesses on the global stage.

Helen Dent, interim CEO of BIVDA (British In Vitro Diagnostics Association), praised the MHRA’s proactive approach to charting the roadmap for new UK medical device regulations. Stressing the importance of patient safety and accessibility, Dent welcomed the proposed timeline of measures as a positive stride towards achieving these objectives.

She expressed BIVDA’s commitment to collaborating with the MHRA, industry stakeholders, and members to ensure the successful implementation of these regulations.

The visual timeline of the MHRA roadmap can be found here.

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