Reporting Safety Issues
Medical device safety issues can be identified through manufacturers (or their authorised representative), healthcare professionals and members of the public submitting reports to the HPRA. Information sharing with other competent authorities and receipt of safety concerns from distributors and importers also assist in the identification of safety issues.
Medical device safety issues can be identified through reporting. Reports can come from manufacturers (or their authorised representatives), importers, distributors or healthcare professionals. The HPRA also receive reports from members of the public or through information sharing with other competent authorities
Members of the Public and Healthcare Professionals
The HPRA strongly encourages members of the public and healthcare professionals to report any safety issues that they have experienced with a medical device to us. We 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:
- email (firstname.lastname@example.org)
- telephone (01 676 4971)
- post (Medical Devices Department, HPRA, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77)
Increased levels of reporting from healthcare professionals, members of the public 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 to ensure that the manufacturer of the device concerned, or their authorised representative, is also informed of the report.
The HPRA has developed specific guidance that provides additional information to healthcare professionals in relation to Cardiotocography (CTG) devices and vaginal mesh implants. The aim of the guidance documents is to assist healthcare professional in the identification of incidents and complaints associated with these types of devices and to help determine if a type of incident is reportable to the HPRA.
CTG Reporting Guidance
Vaginal Mesh Implants Guidance
It is mandatory for manufacturers to report vigilance issues to the appropriate national competent authority. These requirements are outlined in the Medical Device Regulation (MDR). For in-vitro diagnostic medical devices, these requirements are outlined in MEDDEV 2.12-1.
Manufacturers should submit vigilance reports to email@example.com.
Distributors / Importers
Under the requirements laid out in the Medical Device Regulation (MDR), should a distributor or importer, that is based in Ireland, consider or have reason to believe that a device presents a serious risk or is a falsified device, the distributor or importer must inform the HPRA of such concerns. If the affected device is available in other EU Member States, distributors and importers must inform the competent authorities of the affected markets of the potential serious risk or falsified device.
Distributors / importers based outside of Ireland must also inform the HPRA if they consider or have reason to believe that a device available on the Irish market presents a serious risk.
Distributors and importers can provide the HPRA with such concerns by sending an email detailing all relevant information to firstname.lastname@example.org