CE-marked Products for IVD use

What is IVD?
IVD is the abbreviation for in vitro diagnostics. IVD products comprise reagents, equipment, solutions and other consumables which are combined to allow specimens from the human body to be examined. The IVD directive (European Directive 98/79/EC) defines a uniform level of quality and reliability for these products across the European Union. This product reliability guarantees that all products meet identical quality and purity requirements and thus guarantees maximum reproducibility for your experiments and analyses. This is certified by the manufacturer applying the CE symbol to the product. This high degree of reliability is especially important whenever the objective is to assess physiological samples in a clinical laboratory to enable therapeutic measures to be defined as the final step.

How does this standard benefit the product and the user?
The directive applies within the EU and affects all clinical laboratories performing human diagnostics with a therapeutic purpose. This approval is only valid within the EU; in non-EU countries Bender MedSystems products do not carry the CE-mark, however these products have the same quality.

Which groups of customers does the new IVD directive apply to?
Many Bender MedSystems products are used in a clinical environment, and some are involved in diagnostic procedures. Bender MedSystems’ products are in full compliance to the new directive, and all IVD certified products carry the CE-mark.

Which products are basically affected?
Medical devices to be used in vitro for the examination of specimens derived from the human body to provide information about a physiological or pathological state or abnormality or to monitor therapeutic measures are covered by the IVD directive (Article 1 of the IVD 98/79/EC).