Compliance

The purpose of compliance is to ensure that the provisions of medical devices legislation are complied with after devices are placed on the market or put into service. It aims to ensure that non-compliant devices are removed from the market. 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 where for example the number of adverse incident reports exceed those expected or as a result of a singe serious incident
Random and spot checks may also be carried out on the Irish market
Health monitoring provisions where national restrictions on availability in the interest of and protection of public health or safety are introduced in accordance with legislation

In the event of a serious non-compliance that cannot be resolved, the issue may be passed to the Enforcement Section for investigation.

The Irish Medicines Board - www.imb.ie

Compliance