Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Market Surveillance

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Compliance/Market Surveillance The purpose of the HPRA's medical devices compliance programme is to ensure that the provisions of medical devices legislation are complied with. Compliance can be conducted in a number of ways: • review of technical documentation • samples may be taken from the market place from time to time and be subject to examination and testing • compliance activity as a result of adverse incident trends • random and spot checks may also be carried out on the Irish market • restrictions on availability in the interest of public health • audit of manufacturing facilities or authorised representatives

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