about edma
TRANSCRIPT
World of IVDs
Vicky Voulgaraki EDMA, Executive Committee member
7th ‘Patient – MedTech Dialogue Meeting21st March 2014
About in vitro diagnostics (IVDs)
IVDs are non-invasive tests performed on biological samples (for example blood, urine or tissues) to diagnose or exclude a disease.
IVD tests are performed on samples.Samples include blood, urine, stool, sweat and saliva.
IVD tests help -Diagnose-Monitor-Screen-Assess predispositions
Commonly known IVDs
Blood glucose monitor
Pregnancy test
Blood type identification test
Breast cancer screening
What is the difference between IVDs and medical devices?
•IVDs never come into direct contact with a person. They provide information on a sample from a person •IVDs do not treat patients. The role of IVDs is to provide information that enables making of healthcare decisions by HCPs and patients
What is the difference between IVDs and pharmaceuticals?
• IVDs are tests used on samples taken from a human body to determine status of health unlike pharmaceuticals, which aim to treat or manage a condition or disease
• IVDs do not treat patients. The role of IVDs is to provide information that enables making of healthcare decisions by HCPs and patients
• An IVD has no physical contact with the body unlike medicines, which are designed to be absorbed into the body and act systematically
• For IVDs, innovation results primarily from clinicians’ insights, rather than laboratory exploration. For drugs, R&D takes place to identify a specific compound or molecule, and it takes several years for a new drug to enter the product pipeline
EDMA represents the interestsof the IVD industry active in Europe
• Founded in 1979• 20 members of staff in Brussels• A recognized healthcare stakeholder at EU level
• 23 national associations• 44 major companies engaged in the research, development, manufacture or distribution of IVDs• To raise awareness of the importance, usefulness and added value of IVDs in healthcare• Contribute to the development of legislative and regulatory framework that will shape the IVD industry’s future.• Provide technical, regulatory and market research information to our members.
How Does EDMA Work?
EDMA Priority: Revision of IVD Directive
In October 2012 EDMA, representing the in vitro diagnostics industry in Europe and Eucomed, representing the medical technology industry in Europe, launched the MedTech Europe alliance to represent the common policy interests of both associations more effectively and efficiently.
MedTech Europe, which sits underneath both founding members, remains a separate entity, as are EDMA and Eucomed.
Thank you!
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