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Date Title
07/05/2002 Guidance Note 10: Guidance Note to Custom Made Dental Device Manufacturers
06/11/2002 Guidance Note 5: Guidance Notes for Manufacturers on Clinical Investigations carried out in Ireland
26/03/2004 Guidance Note 6: Glossary of Terms for Medical Devices
05/09/2005 Guide: Manufacture of Medical Devices within Healthcare Institutions
01/05/2007 IMB Position Paper: Manufacturing / Adaption of Splints and Splinting Material by Professional Users
24/04/2008 Guidelines for Safe and Effective Management and Use of Point of Care Testing
01/01/2009 Medical Devices EToken User Guide
14/01/2009 Guide for Healthcare users to the on-line Vigilance Reporting System for Medical Devices
14/01/2009 Guide for Industry users to the on-line Vigilance Reporting System for Medical Devices
27/04/2009 Guide to the Classification of a Medical Device
11/05/2009 Guide for Manufacturers of General Class In-vitro Diagnostic Medical Devices
14/12/2009 Guidelines for Safe and Effective Management and Use of Point of Care Testing in Primary and Community Care
04/06/2010 Guide for Ethics Committees on Clinical Investigation of Medical Devices
09/08/2010 Guide for Manufacturers of System and Procedure Packs regarding Legislative Requirements
23/08/2010 Guide for Medical Device Manufacturers on Auditing by the Irish Medicines Board to the Medical Device Regulations
27/08/2010 Guide for Class I Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
18/06/2012 Guide for Custom-made Medical Device Manufacturers on Compliance with European Communities (Medical Devices) Regulations, 1994
18/06/2012 Guide to the In-vitro Diagnostic Medical Devices Legislation
06/07/2012 Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices
19/07/2012 Registration of persons responsible for placing Medical Devices on the market
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Date Printed: 24 May 2013

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