Guidance documents – medical devices Guide to clinical investigations carried out in Ireland PDF : 183 KB | 25/03/2025 View tracked changes 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 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 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 to drug-device consultations PDF : 156 KB | 02/06/2008
