Medical Devices Regulation (MDR)

MDR transitional provisions

What are MDR transitional provisions and how can they affect your medical device?

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Qualification and classification

Find information on how to qualify and classify your medical device under the MDR.

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Clinical investigations

Guidance on how to conduct or modify clinical investigations for medical devices in Ireland.

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Reprocessing of single-use devices

What are single-use devices (SUDs) and what are the requirements for reprocessors and health institutions?

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Drug-device consultations

Find information on how to apply for a drug-device consultation to verify the safety and quality of your medical device.

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