Most in vitro diagnostic medical devices and some general medical devices are often liquid solutions (“preparations”) consisting of a mixture of substances. These substances may be dangerous. Depending on their concentrations, this may result in solutions that are classified as dangerous.

According to European Directive 1999/45/EC, an assessment has to be made in order to determine whether the preparation is dangerous. The classification of the preparation will determine the impact on labeling and the need for making a Material Safety Data Sheet available to the user. The IVD Directive 98/79/EC explicitly mentions that IVDs are subject to these regulations.

Qarad can assess all your preparations and determine the labeling requirements. We can give you very precise instructions for your labeling (danger symbols, risk and safety phrases, component name). In addition, we can make your Material Safety Data Sheets.

Thanks to our experience, we can offer you a very price effective solution.

Contact us for more information or a price quotation.