Guidance documents – medical devices
Guide to clinical investigations carried out in Ireland
PDF : 181 KB | 25/03/2025
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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
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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