EU IVDR Classification: Classes A, B, C & D

How EU IVD classification changed under the IVDR

IVD classification in the European Union changed drastically under the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR), which replaced the In Vitro Diagnostic Directive (IVDD) in May 2022. The majority of “general IVD devices (self-certification) under the IVDD were reclassified under the IVDR and now require a conformity assessment review by a Notified Body. For example, an IVD assay for breast cancer that could self-certify under the IVDD is now a moderate-high risk Class C device under the IVDR.

IVD manufacturers for legacy devices are granted long transition timelines. But these timelines will come to an end step-by-step, and IVD manufacturers will require new CE Marking under the IVDR to remain on the EU market. If your device classification changed under the IVDR, it is essential to understand your new classification and its requirements so you can select the appropriate conformity assessment route and engage with a Notified Body.

How IVDs are classified under the IVDR

IVDs are classified according to 10 implementing and seven classification rules laid out in Annex VIII of the IVDR. It is important that all implementing and all classification rules are taken into account for the classification of an IVD or an accessory for an IVD. This is also important for the classification of software and near-patient tests.

The implementing rules describe the overall concept and general instructions on how to apply the rules. The rules are assigned to a product based on its intended purpose, which should be defined by the manufacturer in accordance with the criteria in IVDR Annex I 20.4.1 c). When the implementing rules are assessed to qualify the device as an IVD, the classification rules define four tiers of increasing risk to the user, patient, or public health:

• Class A (sterile or non-sterile) - lower individual and public-health risk; only products within the IVD definition qualify
• Class B - moderate individual risk and/or low public-health risk, subject to the actual rule
• Class C - higher individual risk and/or moderate public-health risk, subject to intended purpose
• Class D - high individual and public-health risk, subject to the actual rule

MDCG Guidance Document 2020-16 Rev.3 provides deeper explanations of each rule, how they are applied, and examples.

How classification affects regulatory requirements under the IVDR

Confirming that your device is regulated under IVDR and classifying your IVD device are the first steps you should take toward CE Marking. Your device class defines your conformity assessment procedures and these further define the regulatory pathway, from Technical Documentation, Quality Management System and clinical evidence to the level of involvement from your Notified Body.

Under the IVDR, Class A non-sterile IVDs are the only devices eligible to self-affix the CE Mark (after completing the necessary steps and documentation) without a Notified Body review. All other IVD devices, including Class A sterile, require a conformity assessment review and EC Certificate from a Notified Body.

Intended-purpose inputs for a defensible class

Assess every applicable rule and use the strictest applicable classification. A disease name or “rapid test” label alone cannot establish class. Software must first meet the IVD definition; not all laboratory software is an IVD. Confirm the current Commission classification guidance and IVDR Annex VIII. Connect the result to CE marking, performance evidence and the class-based PMS/PSUR rules.

For regulatory terminology and the authority framework, see the EU MDR.