In Vitro Diagnostics Industry and Guidelines

At the request of the Health Ministry, this last category will be increased to limit the use of antibiotics, responsible for more frequent resistance of pathogenic germs to treatment. A test to detect the presence of streptococcus A in throat cultures will help immediately determine whether a case of angina is caused by a virus and, thus, does not need treatment with antibiotics (3 out of 4 cases) or by a streptococcus A that must be treated with antibiotics.

According to a study performed by the URCAM (Union Régionale des Caisses d’Assurance Maladie or Regional Medical Insurance Fund Association), taking into account the unitary cost of the test, savings in antibiotics could reach 11.3 million euros at the national level, considering that approximately 9 million anginas are observed annually in France.

In Vitro Diagnostics Industry and Guidelines

In France, medical devices used for in vitro diagnostics (reagents and instruments used by clinical pathology laboratories) are governed by the AFSSaPS.

A European directive provides guidelines for devices manufactured and sold by the in vitro diagnostics industry. Directive 98/79/CE published on December 7, 1998 allows CE-labeled products to be marketed since June 7, 2000. The directive will be mandatory as of December 7, 2003 with a period of two years to sell stocks of European suppliers. As of December 7, 2005, all products on the market must comply with this directive. It was transposed into the French legislation by an ordinance in March 2001.

With the directive on “in vitro diagnostic medical devices”, CE-labeled products can freely circulate in Europe. These devices must meet quality, safety and performance criteria. Quality assurance systems must be implemented by the manufacturers and regular audits must take place. For a list of risk-associated products (list II A), validation must be performed by an independent exterior organization (Notified Body) before marketing of the product. Those products concerned are reagents for blood banks, blood group tests and AIDS and hepatitis B and C screening. They must meet performance criteria defined by a European group of experts and are described in a summary of product characteristics published by the Official Journal of the European Communities, the Common Technical Specifications. These are mandatory norms.

For all the devices, manufacturers must prepare a technical file made available to health authorities of the European countries. Diagnostics companies must implement a vigilance system. This system must be capable of reacting to any report of a user incident, of analyzing any potential problem or risk, of assessing problems and finding solutions acceptable to the client. Corrective actions applied could be necessary: for example batch recall or product modifications.

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