Manufacturers and authorised representatives
Authorised representative registration
Information on registration of authorised representatives
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HPRA Inspections
An overview of the inspection process including who, what and how we inspect.
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Interruptions of device supply
Learn more about interruptions or discontinuations of supply.
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MDR transitional provisions
What are MDR transitional provisions and how can they affect your medical device?
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IVDR transitional provisions
Information on the transitional provisions of the IVDR including what they apply to.
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Qualification and classification of MDs
Information regarding the qualification and classification of medical devices.
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Qualification and classification of IVDs
Information regarding the qualification and classification of IVDs.
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