Reporting Safety Issues
Medical device safety issues can be identified through manufacturer or healthcare professional reporting, through identification and reporting of issues by members of the public or through information sharing with other regulators (competent authorities).
Users of Medical Devices and Healthcare Professionals
The HPRA strongly encourages those who have experienced a safety issue with a medical device to report that issue to us. We currently operate a voluntary reporting system for users of medical devices, healthcare professionals or any other person who identifies a medical device safety issue.
Issues or concerns about a medical device can be submitted through the HPRA’s online reporting system or by downloading and completing our incident report form. Users may also report medical devices safety issues to the HPRA by:
- post (Medical Devices Vigilance, HPRA, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2);
- email (email@example.com);
- telephone (01 676 4971).
Increased levels of reporting from healthcare professionals and other device users may help in the early detection of adverse trends or safety issues. When the HPRA receives reports of safety issues from users or the public, we are obliged by the medical devices directives to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the report. The source of the report will not be disclosed without prior permission.
There is a mandatory requirement for manufacturers to report vigilance issues to the appropriate national Competent Authority. The European guidelines for a medical devices vigilance system are outlined in MEDDEV 2.12-1.
Detailed guidance on vigilance reporting can be obtained from the following guides: