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UK MHRA Keeps Up Momentum For Change With ‘Pre-Market SI’ Devices Consultation

Stakeholders To Get Another Say In Core Medtech Regulations For Great Britain

 
• By Ashley Yeo

The UK medical devices regulator has announced a consultation on a pre-market statutory instrument to be completed by the end of 2024.

Hot on the heels of the UK government’s announcement that the medical devices post-market surveillance statutory instrument (SI) will be laid in parliament by the end of this year, the regulator has put another major piece of structural work on the table: a consultation on the core regulations as laid out in January in the regulatory roadmap.

This key set of regulations, now referred to by the Medicines and Healthcare products Regulatory Agency (MHRA) as the “pre-market SI,” is scheduled in the roadmap to be laid in parliament by mid-2025

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