CE / UKCA Marking

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and the corresponding UK IVD legislation, products intended solely for general laboratory use are not classified as in vitro diagnostic (IVD) medical devices unless they are specifically intended by the manufacturer for use in a defined diagnostic examination.

This interpretation is supported by Medical Device Coordination Group (MDCG) Guidance MDCG 2024 11, specifically Section 2.4 – Products for general laboratory use, which clarifies that products of a general purpose laboratory nature fall outside the scope of the IVDR unless the manufacturer assigns a specific medical or diagnostic intended purpose.

As Alpha Laboratories’ pipettes, Pastettes, and pipette tips are not designed, intended, or marketed for use with specific IVD assays, diagnostic procedures, or diagnostic systems, they do not meet the definition of an IVD medical device. Consequently, CE IVD marking, UKCA marking, and UKNI marking are not applicable to these products and must not be applied under IVD legislation.

General laboratory use pipettes and Pastettes may nevertheless be used within diagnostic laboratories, provided such use is subject to laboratory level validation, appropriate user training, and routine calibration and maintenance in accordance with the laboratory’s quality management system and procedures.

Where products incorporate electrical or electronic components, those products continue to carry CE and/or UKCA marking as required under other applicable EU and UK legislation, including the Low Voltage Directive/Regulations and the Electromagnetic Compatibility (EMC) Directive/Regulations.

If you require further clarification, please contact us.