Published: 20.03.2020.

A corrective action concerning the status of automatic pipettes and pipette tips for general laboratory use has been agreed within the Conformity and Enforcement (COEN) group, in order to have a harmonised European implementation of the provisions of the Directive 98/79/EC.

This letter informs you of the agreed position within the EU on the status of automatic pipettes and pipette tips for general laboratory use. 

 

Article 1(2) (b) of the IVD Directive 98/79/EC  states 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.”

The qualification provided for in the Directive is where, on the basis of its characteristics, a manufacturer specifically intends that the product should be used for in vitro diagnostic examination. In this case, the product will be qualified as an IVD and therefore must comply with the applicable essential requirements of the IVD Directive. As such this product must be CE marked before placing on the market.

If, however, the product does not possess specific characteristics that make it suitable for one or more identified in vitro diagnostic examination procedures, then the manufacturer is not allowed to qualify its product as an IVD. A manufacturer is not allowed to affix the CE mark on a piece of general laboratory equipment as a marketing claim. Merely adding the statement “for in vitro diagnostic use” to a product is not sufficient to qualify a product as an IVD.

 

The ‘Manual on borderline and classification in the Community regulatory framework for medical devices’ published on the website of the European Commission states:

“2.3. Single or multiple channel pipettes

The single or multiple channel pipettes are used for aspirating and dispensing specific volumes in the microlitre scale. The volume is set by rotating the thumbwheel or the pushbutton.

These pipettes have various laboratory purposes.

Unless the manufacturer’s intended purpose falls within the definition of an in vitro diagnostic medical device, these pipettes must be regarded as a general laboratory product. The latter is excluded from the IVDD by article 1 (2) b IVDD.

"If, however, the product does not in fact possess specific characteristics that make it suitable for one or more identifiedin vitro diagnostic examination procedures, then the manufacturer is not free to bring it within the scope of the IVDD merely by affixing the CE marking to it. In other words, a manufacturer is not able to bring within the scope of the IVDD a product that, in reality, is a piece of general laboratory equipment simply by affixing the CE mark to it".”

http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf

 

MEDDEV 2.14/1 rev. 2, under 1.4. ‘Products for general laboratory use’ specifically refers to pipettes. Examples given of product of general laboratory use and IVD medical devices include general purpose pipettes such as single or multiple [channel] pipettes, plastic pipettes, Pasteur pipettes.

http://ec.europa.eu/health/medical-devices/files/meddev/2_14_1_rev2_ol_en.pdf

Products used in vitro in the preparation of samples that have been obtained for examination are considered neither as IVD nor as accessories and fall outside the scope of the Directive unless, based on their characteristics, they are specifically intended for a particular IVD test. The validation of this specific combination must be clearly documented in the technical documentation.

In spite of the fact that single or multiple channel pipettes have characteristics of accuracy, precision of volumes, and reproducibility, they are used for general purpose and don’t possess specific characteristics that make them suitable for one or more identified in vitro diagnostic examination procedures.

 

Consequently, all Competent Authorities consider that these pipettes and pipettes tips are products for general laboratory use, and that the CE marking of these pipettes has been affixed unduly.

It has been identified that several manufacturers put on the European market single or multiple channel pipettes and tips with CE marking according to Directive 98/79/EC.

In view of a harmonised implementation of the provisions of Directive 98/79/EC, a co-ordinated action by all Competent Authorities was agreed within the Compliance and Enforcement (COEN) group. 

Therefore we are informing you that the CE mark and reference to Directive 98/79/EC must be removed from these pipettes and pipette tips as they do not meet the requirements of the IVD Directive. Any reference to the CE mark and Directive 98/79/EC on information supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials must also be removed.