Monitoring device safety

This page is for patients, the public and healthcare professionals.

It describes why and how we monitor the safety of devices in Ireland.

Why does the HPRA monitor the safety of devices?

We monitor devices to minimise risks to patients, the public and all device users.

How does the HPRA monitor the safety of devices?

We carry out a range of activities. Together, these activities are called ‘market surveillance’.

We evaluate information

We look for trends and safety issues in the information we receive from various sources such as:

  • Manufacturers.
  • Device users such as patients and doctors, and
  • EU and international regulators.

We use a life cycle approach to evaluate the safety and performance of a device.

This means we use information gathered throughout the lifetime of a device. That is from both before and after it is placed on the market.

We also conduct inspections, review documentation and we can request samples of a device.

We prioritise

We prioritise our work based on several factors such as:

  • Risk to public health.
  • Level of use of the device in Ireland.

We take action

If a safety issue is identified, we:

  • Ensure the manufacturer has a plan to resolve the issue.
  • Review the manufacturer’s plan.
  • May take further actions to minimise risk to the public and device users.
  • Work with other regulators on common issues

We communicate

We raise awareness of safety issues when needed.

We do this through our safety communications. 

You can find more details on our safety communications webpage

How can I report a safety issue to the HPRA?

For details on how to report a safety issue to us, please see our reporting webpage.