Manufacturers and authorised representatives
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
Determine whether your product is as a medical device and its correct risk class.
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Qualification and classification of IVDs
Determine whether your product is regulated as an IVD and its correct risk class.
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