CE IVD Labelling
of Pipettes, Tips, Pastettes and Centrifuge Tubes
Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD) provides the regulatory framework for manufacturers and for authorised representatives who wish to place in vitro diagnostic (IVD) products on the EU common market.
Products that satisfy the regulatory requirements are permitted to carry the CE IVD mark.
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.
For a number of years, there has been confusion on whether products such as pipettes and tips could carry the CE IVD mark.
In 2012 the European Commission Directorate General for Health and Consumers issued guidelines on certain products to clarify the position on CE IVD marking.
Download the document from the link below.
Further guidelines were issued in 2014 (and updated in 2017).
In both these sets of guidelines it is very clear that pipettes, transfer pipettes, tips and centrifuge tubes are not permitted to carry the CE IVD mark as they are for general laboratory use only and are not specifically intended to be used for in vitro diagnostic examination.
Hence all such products under Alpha Laboratories brands (including Pastettes, Fastrak, ZAP, alpha+) are not CE IVD marked.
The products are still manufactured to the same high standards even though they do not carry the CE IVD mark.
If you require further clarification please contact us.