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.
Vigilance reporting guidance
The HPRA has developed specific guidance that provides additional information to healthcare professionals who use Cardiotocography (CTG) devices. The aim of the guidance is to assist in the identification of incidents and complaints associated with Cardiotocography (CTG) devices and to help determine if a type of incident is reportable to the HPRA.
CTG Reporting Guidance
Device Specific Vigilance Guidance documents have been developed to complement the requirements of the Medical Devices Directive and the MEDDEV. The Device Specific Vigilance Guidance documents provide additional information to manufacturers that can assist them to identify incidents and complaints associated with specific medical devices, and help determine if a type of incident is reportable to the Competent Authority.
DSVG Template (22 kB)
DSVG 00 Introduction to device specific vigilance guidance
DSVG 01 Cardiac ablation vigilance reporting guidance
DSVG 02 Coronary stents vigilance reporting guidance
Detailed guidance on vigilance reporting can be obtained from the following guides: