In 2012, the European Commission Directorate General for Health and Consumers issued guidelines clarifying that CE Marking applicable to in vitro diagnostic medical devices should be limited to devices intended for specific use for defined in vitro diagnostic procedures. In a 2021 industry published Memorandum of Clarification the leading European Life Science Organizations (GAMBICA, FHI, LABMAS, Laborama, SPECTARIS) stated that pipettes marketed for general use shall not carry CE-Markings.
Micronic Sample Storage Tubes have been developed and manufactured as premium quality products suited to a multitude of laboratory applications and are classified as General Laboratory Products. As such, CE-Marking is not applicable to Micronic Sample Storage Tubes.