Compliance

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