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Publications for the page Pre-Market Activities

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Date Title
05/10/2012 Manufacturer application for compassionate use of a non-CE marked medical device
02/08/2012 Medical device registration system user name and password conditions of use
02/08/2012 Clinical investigations on medical devices
02/08/2012 Guide to the on-line registration system for medical devices
19/07/2012 Registration of persons responsible for placing Medical Devices on the market
19/07/2012 Registration of persons responsible for placing In-vitro Diagnostic Medical Devices on the market
04/06/2010 Guide for Ethics Committees on Clinical Investigation of Medical Devices
18/05/2009 Request for Classification of a Medical Device
01/05/2009 Consultant application for compassionate use of a non-CE marked medical device
27/04/2009 Guide to the Classification of a Medical Device
03/06/2008 Guide to Drug-Device Consultations
03/06/2008 Application for a Drug-Device Consultation
09/07/2003 Clinical Investigation Amendment Application Form
06/11/2002 Guidance Note 5: Guidance Notes for Manufacturers on Clinical Investigations carried out in Ireland
16/10/2001 Clinical Investigation Application Form
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Date Printed: 25 May 2013

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