Guidance documents – medical devices Guide to fees for human products PDF : 375 KB | 16/01/2026 View tracked changes Guide to refusals and appeals PDF : 204 KB | 17/09/2025 View tracked changes FAQ on notification for in-house manufacturers of medical devices and in vitro diagnostic medical devices PDF : 115 KB | 11/10/2024 Guide for health institutions who manufacture and use in-house IVDs in Ireland PDF : 441 KB | 23/05/2024 Guide to clinical investigations carried out in Ireland PDF : 187 KB | 16/05/2024 View tracked changes Guide to attainment of Qualified Person status in Ireland PDF : 114 KB | 10/04/2024 View tracked changes Guide to performance studies conducted in Ireland PDF : 179 KB | 14/06/2022 View tracked changes Guide to placing medical device standalone software on the market PDF : 464 KB | 20/08/2020 Guide to Notified Bodies designation process PDF : 297 KB | 26/11/2017 Guide to electronic submissions - medical devices PDF : 239 KB | 26/11/2017 Guide to drug-device consultations PDF : 276 KB | 02/06/2008
