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Position Papers

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

Recommendations by an EU-wide cross-industry initiative for better regulation in chemicals management

November 2015
Concept of an IVD kit - definition and labelling October 2015
Clinical Evidence proposal on Chapters 47 and 48, Annexes XII and XIII September 2015
Comments on Council Approach on proposed regulation on In Vitro Diagnostic Medical Devices August 2015
 Value of Companion Diagnostics in Personalised Medicine  March 2015 
Suppliers' Charter - Support to Clinical Laboratories seeking accreditation October 2014
Supporting information to the Suppliers' Charter on Clinical Laboratories seeking accreditation to EN ISO 15189:2012 October 2014
Health Technology Assessment for IVDs in the Context of Market Access October 2014
Clinical Evidence and Post Market Follow-Up of In Vitro Diagnostics May 2014
Warnings on Chemical Hazards; CLP the EU implementation of GHS April 2014
Revision of Directive 98/79/EC on In Vitro Diagnostic Medical Devices January 2014 
EDMA Statement on use of Nomenclatures for Regulatory Purposes August 2013
Joint Industry Contribution on EU/US Regulatory Convergence April 2013 
Blood Glucose Monitors under WEEE April 2013
EDMA analysis of proposed Regulation on in vitro diagnostic medical devices - A Need for Separate Legislation March 2013
Healthcare-associated Infections
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