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Regulation of medical devices

Health institutions and HCPs

Information for health institutions and healthcare professionals.

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Importers and distributors

Information for importers and distributors of devices.

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Sponsors of clinical research

Information for sponsors of clinical investigations and performance studies.

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System and procedure pack producers

Information for system and procedure pack producers based in Ireland.

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Manufacturers and authorised reps

Information for manufacturers and authorised representatives.

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Notified bodies

Information about notified body designation and requirements.

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Manufacturing facilities

Information for manufacturing facilities based in Ireland.

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