Safety Information

As the regulatory authority, the HPRA monitors the safety of all medical devices available in Ireland. Our aim is to make sure that these products do not compromise the health and safety of the patient or the person using them. We also work to ensure that medical device manufacturers comply with all safety regulations.

This section of our website includes safety and quality information about medical devices which is primarily for healthcare professionals, patients, carers and other users of medical devices. 

What is a medical device?

A medical device is a health product or piece of equipment that a person uses for a medical purpose. It is not a medicine or drug. Medical devices can diagnose, monitor or treat disease and help people with physical impairments become more independent. Examples of medical devices include wheelchairs, contact lenses and solutions, blood pressure meters, blood glucose meters and pregnancy test kits and complex equipment like infusion pumps, hip implants, coronary pacemakers and artificial heart valves.

A valid medical device bears a CE mark, which indicates that it meets the basic requirements for safety and effectiveness under European law. 

What is a safety issue?

A medical device safety issue is an unexpected problem or malfunction that may affect your health or cause or contribute to an injury, for example a blood glucose meter giving an incorrect blood glucose reading, leading to incorrect treatment.

If a medical device poses a risk to your health and safety, stop using it where possible and report the problem to your healthcare provider, the HPRA and the manufacturer of the device. 

Reporting Safety Issues to the HPRA