Guidance documents – medical devices

FAQ on notification for in-house manufacturers of medical devices and in vitro diagnostic medical devices

PDF : 111 KB | 11/10/2024

Guide to fees for human products

PDF : 254 KB | 02/07/2024

Fees for human medicines and medical devices

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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

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Guide to applications for certificates of free sale for medical devices

PDF : 220 KB | 20/12/2022 View tracked changes

Guide to performance studies conducted in Ireland

PDF : 175 KB | 14/06/2022

Please note that version 1 of this document was approved but not published as a small error was identified in the document on approval. The document has now been corrected.

Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994

PDF : 281 KB | 04/02/2021 View tracked changes

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 to in-vitro diagnostic medical devices legislation

PDF : 171 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 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