Guidance documents – medical devices

Guide to fees for human products PDF : 279 KB | 02/01/2025 View tracked changes
FAQ on notification for in-house manufacturers of medical devices and in vitro diagnostic medical devices PDF : 111 KB | 11/10/2024 Guide for health institutions who manufacture and use in-house IVDs in Ireland PDF : 437 KB | 23/05/2024
Guide to clinical investigations carried out in Ireland PDF : 145 KB | 15/05/2024 View tracked changes
Guide to attainment of Qualified Person status in Ireland PDF : 110 KB | 10/04/2024 View tracked changes
Guide to refusals and appeals PDF : 141 KB | 03/07/2023 View tracked changes
Guide to performance studies conducted in Ireland PDF : 175 KB | 14/06/2022
Guide to Vigilance System for Medical Devices PDF : 144 KB | 04/02/2021 View tracked changes
Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices PDF : 147 KB | 04/02/2021 View tracked changes
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994 PDF : 281 KB | 04/02/2021 View tracked changes
Guide for manufacturers of general class in-vitro diagnostic medical devices PDF : 278 KB | 04/02/2021 View tracked changes
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices PDF : 240 KB | 04/02/2021 View tracked changes
Guide to in-vitro diagnostic medical devices legislation PDF : 171 KB | 04/02/2021 View tracked changes
Guide for distributors of medical devices PDF : 1294 KB | 19/12/2020 Guide to placing medical device standalone software on the market PDF : 459 KB | 20/08/2020 Guide to Notified Bodies designation process PDF : 293 KB | 26/11/2017 Guide to electronic submissions - medical devices PDF : 235 KB | 26/11/2017 Guide for custom-made dental device manufacturers on compliance with European Communities medical devices regulations 1994 PDF : 166 KB | 12/11/2013 Guide to drug-device consultations PDF : 156 KB | 02/06/2008