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MHRA Updates Medical Devices Regulatory Reform Roadmap

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An updated Medical Devices Regulatory Reform Roadmap, Version 2.0 has been released by the MHRA (Medicines and Healthcare products Regulatory Agency, UK).

New Medical Devices Roadmap

Due to the ongoing reform of UK Medical Device regulations, a new roadmap has been issued to reflect the latest updates, including the Statutory Instrument (SI) recently laid before Parliament. The first version of the roadmap was published in January 2024.

Some highlights of the MHRA Medical Devices Roadmap include the following:

    • New regulations for Post Market Surveillance
    • New Regulations for pre-market requirements
    • Policy development
    • Software including AI & digital mental health products

 

The link to the roadmap can be found here: Med_Tech_Regulatory_Roadmap_V2_December_2024.pdf

This roadmap outlines the latest updates and timelines for ongoing UK regulatory planning, along with guidance for navigating evolving regulations. For help navigating these regulations, contact us today.

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