EU IVDR Classification
IVDs are classified according to 10 implementing and seven classification rules laid out in Annex VIII of the IVDR.
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) - low risk (e.g., general lab equipment, sterile specimen containers)
- Class B - moderate risk (e.g., rapid test for flu)
- Class C - high-moderate risk (e.g., blood glucose reagents or breast cancer)
- Class D - high risk (e.g., tests for HIV)
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.
Frequently
Asked Questions
What is the required information to classify my IVD device?
If you already have assessed the implementing rule and confirmed that your product is regulated as an IVD under IVDR, the classification rules will apply based on the information you should have defined in your intended purpose. These should meet all the criteria from Annex I 20 4.1 c). If one or more criteria are not clearly defined in the intended purpose, the classification might not be fully possible and several IVD classes might apply. In these scenarios, manufacturers are strongly recommended to revise their intended purpose and make it clearer. For example, if automation is not defined in the intended purpose, but the instructions for use outline a specific combination for automated use, the automation should be named in the intended purpose. If the indication for the clinical use scenario is not included, different classifications for life-threatening situations might apply.
Can software be an IVD?
Yes, software has been included in the IVD definition and must follow the same criteria as other physical IVD devices.
Is it required to define the intended purpose in accordance with IVDR criteria for legacy IVD devices?
NO, legacy devices follow IVDD, except for specific obligations such as Post Market Surveillance, vigilance, supply chain controls (including EUDAMED) and traceability (UDI). The intended purpose therefore does not need to follow IVDR requirements. However, to plan for an IVDR transition, you need to classify your device and select a conformity assessment route and engage with a Notified Body or even lodge an application with a Notified Body. For all these actions you need to define your IVD class and change your intended purpose to the criteria from Annex I 20 4.1 c). Otherwise, you will not be able to classify your device and you will not be able to conduct the performance evaluation and address the clinical evidence in an adequate way.
How do CE Marking requirements differ between Class A devices and Class A sterile devices?
Manufacturers of class A IVD devices will declare the conformity of their devices by issuing the EU declaration of conformity, after drawing up the Technical Documentation set out in Annexes II and III and meeting the basic requirements to keep a Quality Management System and comply with other applicable EU legislation. For Class A sterile devices, the IVD manufacturer should follow the procedures set out in Annex IX or in Annex XI. The notified body review will mainly focus on establishing, securing and maintaining sterile conditions, Of course the basic requirements from Annexes II and III for Technical Documentation and Quality Management System apply the same way as they do for all IVDs.
