Safety Communications

Safety Notices

The HPRA circulates safety notices in many instances:

  • To highlight a serious public health issue
  • To draw attention to medium / high risk field safety corrective actions / field safety notices
  • To highlight an issue where the manufacturer has experienced difficulty reaching all customers
  • To highlight an issue when either the device manufacturer or distributor to the Irish market no longer exists.
  • To communicate concerning trends identified by the HPRA in relation to particular product families

Learn more about field safety notices

Manufacturer’s Field Safety Notice

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.

The HPRA puts these notices on our website for information.

Learn more about field safety notices

Field Safety Notices - Outstanding Actions

When a field safety notice is issued by a medical device manufacturer on the Irish market, the HPRA seek confirmation from the manufacturer that the required action has been completed. Sometimes, completion of the action is delayed or hampered due to issues experienced by the manufacturer. The HPRA publishes details of field safety notices that have been circulated to the Irish market for which action remains outstanding.

Learn more about field safety notices

HPRA Safety Notices and Manufacturer’s Field Safety Notices

View all safety notices issued by the HPRA and manufacturer’s field safety notices.  The HPRA issued a safety notice in January 2016 outlining the difference between HPRA safety notices and manufacturer’s field safety notices and what actions should be taken on receipt of each.  

Sign up to Alerts

Healthcare professionals can also sign up for automatic alerts when a new safety notice is issued