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