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Please note this is an extract of the original bulletin.

Implementation of medical devices future regime

Page summary:
The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.

Change made:
Added ‘Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices’ and information about ‘future core regulations’.

Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology including AI and diagnostics

Page summary:
MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies

Change made:
First published.

Winners of global AI cardio-health challenge announced

Page summary:
The successful five winners of a brand new challenge from a collaboration of regulators and healthcare organisations in the UK and US have been announced today (10 January 2024).The challenge saw 25 teams of artificial intelligence and machine learning developers from across the globe compete against each other to build models that predicted heart failure-related health outcomes for veterans.

Change made:
First published.

Register medical devices to place on the market

Page summary:
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland

Change made:
Updated ‘Account Management Reference Guide’ & ‘Device Registration Reference Guide’

Export medical devices

Page summary:
Order a certificate of free sale to export medical devices outside the UK.

Change made:
Updated ‘Certificates of Free Sale Reference Guide’

 

Tehelj