Global IVD Products Classification

The Global IVD (GIVD) Classification is the new official nomenclature of the previously-known EDMA (EDMS) classification.

An effective product classification system is critical to the functioning of any industry in the knowledge-based markets of today. A classification scheme assigns a code to each product type or class, allowing quick identification of the product in a language-independent fashion (the specific name of the product is actually not mentioned).

EDMA has been following the development of the European IVD market for many years. In order to allow for the easy compilation and consolidation of market data, EDMA has created a specific product classification scheme for IVDs. This European Diagnostic Market Statistics (EDMS) programme, based on the independent audit of invoiced sales, is the authoritative source of IVD market statistics in Europe. Its objective information serves as a valuable basis for decision-making in the IVD industry.

If you are interested in the market research work of EDMA please visit the page of our Market Research Committee.
 

What kinds of products do manufacturers of In Vitro diagnostic tests make?

The IVD industry produces reagents, analytical instruments, and accessory products that are used to perform diagnostic laboratory tests.

Reagents are solutions of highly-specific biological or chemical substances that are able to react with target substances in the samples. This process will result in a product that can be measured or seen.

The analytical instruments are the various machines and equipment that automate the process and are used to bring samples and reagents together. Analytical instruments measure the result or other qualities and parameters in the samples.

Accessory products, such as the software programs used to run the instrumentation, and control solutions that check the performance of the systems are also produced by the IVD industry.

Together, reagents, instruments, and accessories are referred to as "In Vitro diagnostic systems". Read more about IVD testing and its uses in the About In Vitro Diagnostics section.

2012 Global IVD Products Classification

• Global IVD Products Classification (GIVD)
  

GIVD to GMDN conversion tables

EDMA has been providing its nomenclature for IVD Medical Devices in Europe for several years. However, with the advent of the Global Medical Device Nomenclature (GMDN), the question has often arisen of which GIVD code corresponds to which GMDN code. Since these codes are used in the notification of CE-marked products to Competent Authorities on the EU market, it is important to provide the correct codes as required.

Therefore, EDMA has developed two tables for ease of use of the correlation data which it has gathered as well as an access database containing all the information used to generate these tables:

• Correlation kindly provided by Dr. Tomomichi Nakazaki
• To find a GMDN code from a known GIVD code click here GIVD to GMDN Code;
• To find a GIVD code from a known GMDN code click here GMDN to GIVD Codes;
• The Access Database can also be directly downloaded here: Access Correlation Database (zip file).

It should be noted that the correlation between the two sets of codes is not perfect as there are some GIVD codes for which no equivalent GMDN code currently exists, and vice versa. GMDN may at times go into more detail than the EDMA classification, resulting thus in various possible GMDN codes for a single EDMA code.

EDMA has done its utmost to ensure the completeness and accuracy of these documents. However, as both the GIVD and the GMDN classification systems are constantly evolving, it is possible that some discrepancies may be found in these tables. If you should find any errors please notify EDMA so that these tables may be updated.