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Reach / CLP

CLP (EC Regulation No. 1272/2008 on classification, labeling and packaging of substances and mixtures)

Most In Vitro Diagnostic Medical Devices and some general Medical Devices are liquid solutions (or mixtures) consisting of a mixture of substances. Some substances are classified as dangerous. Depending on their concentration in a mixture, the mixture itself may be classified as dangerous.

The CLP Regulation (EC Regulation No. 1272/2008 on Classification, Labeling and Packaging of substances and mixtures) is a new regulation, introducing a new system for classifying and labeling chemicals throughout the EU. It is based on the United Nations’ Globally Harmonized System (GHS). Over time, the CLP Regulation will replace two previous pieces of legislation, the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC). There is a transition period until 1 June 2015.

Medical Devices and IVD Medical Devices are exempt from the scope of the CLP Regulation. However, since the MD and IVD Directives require manufacturers to define the risks associated with the use of their products and to inform the users of these risks, it makes a lot of sense to assess the risks based on the objective classification criteria in the CLP and to inform the users with the internationally recognized symbols and other labeling requirements from the CLP.

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).

REACH (EC Regulation No. 1907/2006 on Registration, Evaluation, Authorisation and Restriction of Chemicals)

The classification of the mixture (according to the CLP) will determine the need for making a Safety Data Sheet (SDS) available to the user. The content of Safety Data Sheets is regulated by REACH. A SDS has to include the classification and labeling of the chemical together with other safety information.

Medical Devices (with the exception of medical devices which are invasive or used in direct physical contact with the human body) and IVDs are not exempt from the requirement to provide a SDS to the user.

QARAD can assist you in drafting Safety data Sheet conform to the actual REACH regulation.


Contact us for a price quotation.