Quality Auditing & Surveillance

The HPRA carries out audits of medical device manufacturers on a regular basis. The type of audits that are conducted are as follows: 

  • Proactive post-market surveillance audits
  • 'For cause' post-market surveillance audits
  • Custom-made medical device audits
  • Other audits pertaining to the register of medical devices

For more details on the type of audits please see:

The aim of these audits is to ensure that the medical device manufacturer is complying with the 'Essential Requirements' and schedules of the Medical Device Directives and related Statutory Instruments.   

Another key area in which the HPRA is involved in is the surveillance of the medical device market to identify issues and trends in order to highlight priority areas for the medical devices market.   

If you wish to obtain further information on auditing activities please contact a member of the audit team at devices@hpra.ie.