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Title File Type File Size Published Date  
Guide to Fees for Human Products .pdf 256 KB 02/01/2024 View more information
Guide to Applications for Certificates of Free Sale for Medical Devices .pdf 221 KB 20/12/2022 View more information
Guide to Clinical Investigations carried out in Ireland .pdf 145 KB 18/11/2022 View more information
Guide to Performance Studies Conducted in Ireland .pdf 175 KB 16/11/2022 View more information
Guide for Distributors of Medical Devices .pdf 1 MB 18/12/2020 View more information
Guide for Suppliers of First Aid Kits Containing Medicinal Products Supplying Solely to the End-User .pdf 421 KB 01/10/2020 View more information
Guide to Notified Bodies Designation Process .pdf 293 KB 20/11/2017 View more information
Guide to Electronic Submissions - Medical Devices .pdf 235 KB 20/11/2017 View more information
Guide to scientific and regulatory advice for GXP activities .pdf 218 KB 06/10/2017 View more information
Guide to Placing Medical Device Standalone Software on the Market .pdf 460 KB 21/06/2017 View more information
Guide to Information held by the HPRA .pdf 229 KB 14/07/2016 View more information
Guide for Custom-Made Dental Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994 .pdf 167 KB 09/06/2014 View more information
Guide to In-Vitro Diagnostic Medical Devices Legislation .pdf 171 KB 09/06/2014 View more information
Guide for Manufacturers of General Class In-vitro Diagnostic Medical Devices .pdf 279 KB 09/06/2014 View more information
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994 .pdf 282 KB 09/06/2014 View more information
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices .pdf 240 KB 09/06/2014 View more information
Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices .pdf 236 KB 09/06/2014 View more information
Guide to Vigilance System for Medical Devices .pdf 144 KB 09/06/2014 View more information
Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices .pdf 147 KB 09/06/2014 View more information
Guide to Refusals and Appeals .pdf 142 KB 09/06/2014 View more information
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