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Please note this is an extract of the original bulletin.

Regulation of devices in Northern Ireland

Page summary:
Information about the EU Regulations and their implementation in Northern Ireland

Change made:
Updated to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health Institution Exemption

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:
Link to webinar ‘MHRA MedTech Regulatory Reform’ added to section 4.

 

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