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Title File Type File Size Published Date  
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 Applications for Certificates of Free Sale for Medical Devices .pdf 368 KB 02/04/2020 View more information
Guide to Fees for Human Products .pdf 436 KB 17/05/2019 View more information
Guide for distributors of medical devices .pdf 181 KB 14/02/2018 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 460 KB 14/07/2016 View more information
Guide for Manufacturers and Sponsors on Clinical Investigations carried out in Ireland .pdf 162 KB 14/08/2014 View more information
Quality Defect Investigation Reports .pdf 161 KB 09/06/2014 View more information
Guide to Placing System and Procedure Packs on the Market .pdf 224 KB 09/06/2014 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 157 KB 09/06/2014 View more information
Guide for Custom-made Medical Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994 .pdf 506 KB 09/06/2014 View more information
Guide for Manufacturers of General Class In-vitro Diagnostic Medical Devices .pdf 317 KB 09/06/2014 View more information
Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations 1994 .pdf 341 KB 09/06/2014 View more information
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices .pdf 382 KB 09/06/2014 View more information
Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices .pdf 341 KB 09/06/2014 View more information
Guide to Vigilance System for Medical Devices .pdf 249 KB 09/06/2014 View more information