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Position Papers

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EDMA position papers are produced to disseminate the consensus position of our members as regards to a given issue. They provide a valuable tool to allow EDMA members to communicate the opinions of the IVD industry to any interested party. They are drafted by the EDMA Task Force with expertise on the subject and then referred to the Regulatory Affairs Committee and the Executive Committee, NAMs and CAMS for approval.

Position Papers are publicly available documents which can be distributed to any interested party.

Position PapersDate of Issue
Quality Management System Inspections April 2011
Joint AdvaMed – EDMA paper on the WHO prequalification programme Sep 2010
Language Requirements For Texts Displayed on Screens in Instruments For Professional Use Jan 2004
Rev Aug 2009
Unit-Price, Result-Based Contracts for the Supply of Diagnostic Systems Jan 2009
Joint Industry Position Paper on Recast of the Medical Devices July 2008
Unique Device Identification Feb 2008
Laboratory Accreditation Oct 2007
EMIG statement on revision new approach regulation - article 19 notification and conformity assessment bodies Sep 2007
Labelling of Devices Containing Radioactive Substances Oct 2006
Estimation of Uncertainty of Measurement in Medical Laboratories Sep 2006
Electro-magnetic compatibility (EMC): Directive 89/336/EEC Nov 1994
Rev Sep 2005
Laboratory Medicine and Traceability: views and needs of industry for compliance with essential requirements of the IVDD May 2005
Standardisation May 2004
Nucleic Acid Extraction Kits and the IVD Medical Device Directive Jan 2004
Software and the IVD Directive Jan 2004
Genetic Testing Oct 2003
The IVD Directive and "borderline products" Nov 2001
External Quality Assessment Schemes (EQAS) Feb 1995
Rev May 2001
General aspects of Medical and Metrological Traceability in Laboratory Medicine Mar 2001
Supply of Instructions for Use by Other means (for IVD Reagents for professional users) Oct 2000
Languages and the IVD Directive Nov 1998
EMIG Statement on Own Brand Labelling (Appendices A - B) Jan 1998
Benefits of a regulatory system for IVD Medical Devices, based upon essential requirements plus quality systems Jan 1997
The role of diagnostic tests for the recognition of infection markers for hepatitis B/C and HIV, and for ensuring the safety of blood supply Apr 1995
Eco-Management and Audit Scheme (EMAS) Sep 1994

 

List of EDMA Position Papers and Guidance Documents