IVD EDMA Classification
The German Medical Devices Act (Medizinproduktegesetz, MPG) required a consistent, structured naming for the notification of in-vitro diagnostic devices. For this purpose, the EDMA IVD Classification, the product classification of the European Diagnostic Manufacturers Association (EDMA), had to be used.
The EDMA terms still available in the German Medical Devices Information and Database System (DMIDS) originate from older classification versions. If necessary, BfArM provides these as files.
- IVD Classification Reagents, Revision 5, 2001 (PDF, 142 KB)
- IVD Classification Instruments, Revision 3, April 1997 (PDF, 106 KB)
Further Information
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