Our Role

  • Our aim is to make sure that medical devices are as safe as possible and that they work as intended.

 

  • A medical device is a health product or piece of equipment that a person uses for a medical purpose.  They can diagnose, monitor or treat illness or disease and assist people with physical impairments. Examples include plasters and bandages, wheelchairs, contact lenses, blood pressure meters, pregnancy test kits as well as more complex equipment like incubators, hip implants and coronary pacemakers.

 

  • Our regulatory role involves monitoring the safety of medical devices in Ireland after they are placed on the market.

 

  • Most medical devices are initially assessed and approved by a separate organisation called a ‘notified body’ which approves them to be placed on the market.  A medical device that has been approved will bear a CE mark – this indicates it meets the basic requirements for safety and effectiveness under European law.

 

  • It is also the role of the HPRA to designate and continuously monitor the performance of the Irish Notified Body which must have the capability to assess and approve specific medical devices.

 

  • We operate a national reporting system for medical devices. We encourage users of devices to report incidents or problems associated with their use to the HPRA through our website or by contacting us or the manufacturer directly.

 

  • When new safety or quality information emerges we ensure that medical device users are informed and we advise them of any actions that they may need to take.

 

  • We carry out on site audits of selected manufacturers of medical devices to monitor compliance with relevant standards and legislation. We may also audit in response to a significant medical device safety or quality concern.

 

  • Where we identify a significant safety or quality concern with a device, there are a range of regulatory actions we can take to protect public health. These include changes to labelling, safety notices and recalling the product from the market. We can also request changes or modifications to the device itself.

 

  • The HPRA is an active member of EU committees and working groups involved in the assessment and development of medical devices regulation on the market.