We would like to update you on the classification of a number of items within the Ramboldi single-use plastics portfolio, in accordance with the In Vitro Diagnostic Medical Device Directive 98/79/EC.
It has been noted that two product ranges, Plastic Pasteur Pipettes, and Centrifuge Tubes, have been incorrectly classified and CE marked under the In Vitro Diagnostic Medical Device Directive 98/79/EC. Only products that satisfy the regulatory requirements are permitted to carry the CE IVD mark. Although there has been some confusion over the years as to whether some items should carry the CE mark, it has always been clear that products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination. In all documentation supporting the directive, it is made clear that both transfer pipettes and centrifuge tubes are not permitted to carry the CE IVD mark as they are for general laboratory use and are not specifically intended to be used for in vitro diagnostic examination.
With immediate effect, the Plastic Pasteur Pipettes and Centrifuge Tube products indicated in the attached table will no longer fall under the scope of in vitro diagnostic medical devices in accordance to the In Vitro Diagnostic Directive 98/79/EC and so will no longer carry the CE mark once current stocks are depleted. We would like to reassure you the product will continue to be manufactured to the same exacting standards as it is currently, and although classed as general laboratory products, can still be used to perform in vitro diagnostic procedures where necessary.