MHRA ‘Aware Of UK Cliff Edge’ In Post-Brexit Devices Regulation Plan

The UK government’s response to the MHRA consultation on future device regulation will be published very soon. So says the agency’s new health care access officer. But will there be enough time for companies to comply with it?

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The sense that the UK Medicines and Healthcare products Regulatory Agency (MHRA) may have a contingency plan to ensure device manufacturers have enough time to comply with the new UKCA marking regulation grows with every week that the MHRA/government response to the UKCA marking consultation is delayed.

This promised document ̶ the next stage in the process to establish UK-specific device regulation ̶ is already many weeks behind schedule. This suggests that compliance with the 1 July...

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