The new article provides an overview of the regulatory status of accessories and related products as set forth under the existing legal framework.
Table of content
The Medical Device Coordination Group (MDCG) has published a guidance document dedicated to the qualification of in vitro diagnostic medical devices. The document provides a general overview of the applicable regulatory requirements set forth under the relevant legislation, as well as additional recommendations and clarifications to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations, and could also be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations. In particular, the present guidance provides critical clarification on the qualification of accessories, specimen receptacles, and other related products under the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU 2017/746).
The document elaborates on distinctions, specific use cases, and classification criteria to help manufacturers ensure compliance with IVDR requirements.
Accessories
Under Article 2(4) of the IVDR, an accessory is defined as an article not itself an in vitro diagnostic medical device (IVD) but intended to be used with an IVD to:
- Enable the IVD to be used for its intended purpose.
- Assist the medical functionality of the IVD in line with its purpose.
An example would be a cleaning solution specifically designed for an automated IVD instrument that qualifies as an accessory to that instrument.
Specimen Receptacles and Products for Specimen Collection
The IVDR defines specimen receptacles as devices intended for the primary containment and preservation of human-derived specimens for diagnostic purposes. Their role extends beyond initial containment to ensuring the specimen’s integrity by protecting it from environmental factors such as light, temperature changes, and contamination.
The key characteristics of such products would be:
- “Primary” containment refers to the receptacle that comes into direct contact with the specimen, not necessarily the first container.
- “Preservation” includes protection, not necessarily chemical preservation.
Examples of IVD specimen receptacles are:
- Blood collection tubes.
- Urine or stool specimen containers.
Non-IVD examples:
- Blood bags for transfusion (classified as medical devices under MDR).
- General laboratory tubes not specifically designed for diagnostic examination.
Products Used for Specimen Collection
- Without Direct Human Contact: Products like pipettes used to transfer specimens, but not intended for primary containment or preservation, are not classified as IVDs.
- With Direct Human Contact: Devices that are invasive or in direct contact with the human body during specimen collection are classified as medical devices under MDR, not IVDs.
Examples of medical devices covered by this rule would include:
- Needles, lancets, or lancing devices.
- Swabs for specimen collection.
- Sweat cards used in cystic fibrosis diagnosis.
As further explained by the MDCG, diagnostic devices that operate without specimens derived from the human body are not considered IVDs under the IVDR. Instead, these devices are typically classified as medical devices under MDR.
Such examples of non-IVD products include:
- Non-invasive glucose monitors using energy emissions.
- Pulse oximeters measuring oxygen levels through infrared light.
- MRI scanners used for diagnostic imaging.
It is important to mention that standalone software, however, can fall under the IVDR if it processes data from other IVDs to provide diagnostic information.
The IVDR also explicitly excludes products designed for general laboratory use unless such products are specifically intended by their manufacturer for diagnostic examination.
Qualification criteria for IVDs to be considered when making such a determination would generally include:
- Products must possess specific characteristics making them suitable for IVD purposes.
- Merely labeling a product “for in vitro diagnostic use” does not qualify it as an IVD.
Examples of non-IVD laboratory products:
- General laboratory items like paraffin or stains used in specimen preparation.
- Receptacles without specific diagnostic characteristics.
It is also stated that if a product is specifically designed to function as part of a diagnostic process, it must comply with IVDR as either an IVD or an accessory.
Conclusion
In summary, the present guidance provides detailed criteria for qualifying accessories, specimen receptacles, and related products under the IVDR, ensuring clarity for manufacturers navigating the regulatory framework. It also emphasizes that products without a clear diagnostic purpose, or those classified as general laboratory equipment, remain outside the IVDR’s scope unless they meet accessory or IVD definitions.
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