General laboratory instruments, also known as GLUs (devices for General Laboratory Use), have a somewhat murky status under IVDR Article 5.5 requirements for labs. As with RUO devices, there is no “official” definition of GLUs, and no regulation of them.  

And while including GLUs in a workflow sounds less complicated than the in-house use of RUOs, labs are put through the wringer here again because they somehow sense they may need to document them nonetheless. And as it turns out, in some cases they are right. 

Under Article 5.5, the inclusion of GLU components in technical documentation for in-house tests depends on their relevance to the test’s intended purpose as well as its safety and performance. 

Here’s the lowdown. 

What are GLUs? 

Equipment for “General Laboratory Use” refers to a wide range of instruments commonly used in various types of labs for scientific research, analysis, testing, and experimentation. Examples of GLUs include pipettes and test tubes, but also microscopes and spectrophotometers—standard instruments that generally play a supportive role in many different clinical lab activities. 

ISO 15189 requires that such general laboratory devices are documented in the lab QMS, including routine testing and calibration. 

Two types of GLUs 

GLU devices with no medical intended purpose 

“Typical” GLUs are not intended by the manufacturer to be used specifically in diagnostic procedures, and thus do not fall under the IVDR. Such devices might instead be governed by other EU directives like the General Product Safety Directive or the EMC Directive, and a CE marking may or may not be required.

GLU devices with a medical intended purpose 

If a manufacturer claims for a given general device an intended purpose that falls under the IVD definition, the GLU constitutes an IVD device. In other words: When a device, by virtue of its characteristics, is explicitly intended by its manufacturer to be used for in vitro diagnostics, the device constitutes an IVD and is regulated by the IVDR, even if its purpose seems general. 

If the manufacturer has given a general device an intended purpose as an IVD, they are typically classified as CE-IVD and assigned to Class A (low risk).  

The following examples illustrate the difference: 

	GLU product	CE-IVD
Centrifuges	General centrifuges, cytospin	Hematocrit centrifuge
Pipettes	General purpose pipettes (e.g., single or multiple pipettes, plastic pipettes, Pasteur pipettes)	Blood coagulation pipettes with automatic timing (accessory for coagulometer)
Tubes and flasks	Erlenmeyer flasks, general plastic tubes	Blood collection tubes, urine specimen containers
Plates	General empty ELISA plates, general empty Petri dishes	Coated microtiter plates for the diagnosis of Lyme’s disease
PCR machines	General PCR machine	PCR machine intended for IVD purposes: e.g. detection and differentiation of influenza/SARS-CoV-2 RNA
Detection equipment	Mass spectrometers, spectrophotometers, ELISA readers providing raw data which is not readily readable and understandable by the user (e.g. peaks, OD).	McFarland bacteria density reader specifically intended for IVD examination of human specimens

Source: MDCG 2024-11 

Implications for in-house tests 

If a lab incorporates a GLU device into an in-house workflow, IVDR Article 5.5 requires that the device be appropriately validated for its role within the test. As for any component involved in a workflow under Art. 5.5 of the IVDR, risk assessments and justifications for using the GLU device must be part of the technical documentation. 

The following require consideration by the lab: 

• Altering the GLU’s intended purpose: For a given in-house test, if you stray from the intended purpose of the GLU manufacturer, then you need to document and justify this particular use of the general device for your test. 

• Intended purpose of other components: And even if you do remain within the intended purpose of the manufacturer, you need to check if any other components in the workflow specify the use of a different general instrument in their intended purpose. If so, then you need to justify your decision. 

• Performance validation and traceability: The reliability and reproducibility of tests results are the core requirements of the IVDR, therefore labs are expected to document components that may introduce variability in tests results. While GLU components are generally considered neutral, any GLU instrument that could introduce variability or impact quality would need to be traceable within the technical documentation. 

• Risk management: If a GLU component, such as a pipette or general-use centrifuge, could affect the performance, stability, or accuracy of an in-house test, it should be included in the technical documentation as part of the risk assessment.  

To sum it up 

Under IVDR Article 5.5, documenting GLU components boils down to this: If it could impact safety, performance, or risk, better write it down. Even a simple centrifuge might have a role in the spin cycle of compliance. 

*We have compiled the above information to the best of our knowledge, yet our blog entries do not constitute expert advice and cannot substitute your own examination of the legal situation applicable to you and your institution.  

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