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CE IVD Labelling of Pipettes, Tips, Pastettes and Centrifuge Tubes

March 2015

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.

CE IVD LogoIn 2012 the European Commission Directorate General for Health and Consumers issued guidelines on certain products to clarify the position on CE IVD marking.

 

Further guidelines were issued in 2014.

 

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+) will not be CE IVD marked once current stocks are depleted.

The products will still be available and manufactured to the same high standards – they will just not carry the CE IVD mark.

If you require further clarification please contact us.