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Using medical devices & IVDs in Ireland

This page is for hospitals and healthcare professionals in Ireland who use medical devices and in vitro diagnostic medical devices.

It provides an overview of the various routes for using devices and explains the key regulatory considerations for each. It also provides practical information on how to verify the compliance of devices and how to ensure their safe use.

While it is important to understand the various routes for using devices, most devices available on the EU market are CE-marked. 

To understand more, explore the pages below.

CE marked medical devices

Learn about the key considerations of using CE marked medical devices in a hospital.

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In house manufacturing

Learn about the key considerations of manufacturing devices 'in house'.

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Custom made medical devices

Learn more about the key considerations of using custom made medical devices.

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Compassionate use applications

Learn how to apply for a compassionate use application with the HPRA.

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Reprocessing medical devices

Learn about the key considerations for reprocessing medical devices in Ireland.

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Medical devices & clinical research

Learn about using medical devices & IVDs subject to clinical research.

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