Outline of the EU IVDR 2017/746: New Rules For Classification

One of the (many) significant changes brought about by the EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 is the establishment of a rules-based classification system. While this now aligns EU IVD classification with the GHTF/IMDRF principles of IVD classification and similar classification systems used in other well-established markets, manufacturers without previous experience in such systems may be unsure on how to appropriately classify their devices. 

Consider These Questions Prior to Classification Review

There are four broad questions that manufacturers should consider prior to reviewing the classification rules established in the IVDR and determining their applicability, in consultation with relevant MDCG guidance (MDCG 2019-11 and Manual on borderline and classification), which include: 

1. What type of product is my IVD?

IVDs can consist of several types of products used alone or in combination with other devices. Particularly in a pathology laboratory setting, including reagents, calibrators, control materials, instruments and software. Reagents, calibrators and/or control materials are also quite commonly placed on the market as a ‘kit’. For the purposes of classification, it is critical that manufacturers identify each and every device that it places on the market and classify each device separately. In the case of ‘kits’ this can be as simple as listing the respective ‘kit’ components, as well as any products that fall within the definition of an ‘accessory for an IVD’, prior to determining their respective classifications. 

2. What is its intended purpose?

This is the most critical consideration in classification. It is essential that manufacturers have established clear, specific intended purpose(s) for their IVD (in its labelling). As noted in MDCG 2020-16, “the intended purpose of the device and its claims, shall be sufficiently specified to enable a clear attribution of the class. Ambiguous claims may lead to higher classification.” In the case of multiparametric IVDs, even for multiparametric calibrators and/or control materials, this is fundamental. As the classification rules also contemplate different intended users (e.g. devices for self-testing or near-patient testing) and, in some instances, specific types of specimens, all intended users and specimen types should be mapped out for each IVD. 

3. What is its mechanism of action?

The question of how an IVD achieves its intended purpose is particularly pertinent for instruments and software. Where instruments have an independent measuring function which does not use any additional reagents, these are classified according to the intended purpose of the analysis. In the case of instruments, manufacturers should list each IVD analysis performed by the machine within the scope of its intended purpose. They should alsoclearly indicate whether the analysis is reagent-driven or instrument-driven. In the case of software, after having considered its qualification as an IVD within the context of MDCG 2019-11 (including software-as-a-service (SaaS) offered to EU patients), the primary consideration for mechanism of action will be whether it drives or influences the use of a device or is independent of any other device. It is recommended that this be clearly defined prior to classification. 

4. As applicable, what is the criticality of the information provided by the IVD?

Where there is a high level of individual and public health risk (e.g. HIV blood donor screening), devices will be subject to a higher risk classification. Inversely, where individual and public health risk are low (e.g. general culture media), device classification will also be lower. There are several classification rules directly related to the criticality of the information provided by an IVD. Therefore, prior to classification, we recommend that manufacturers also map out both the individual and public health risk levels associated with the information provided by their IVDs, as applicable.

Prepare for Your IVDR Transition

While the EU Commission has extended the transition period for the majority of IVDs under the IVDR, it is still important that manufacturers begin their preparations for transition, especially with determining the classification of their products, as that impacts the duration of the transition period. The availability of Notified Body resources and constraints on these resources are expected to remain for some time. IVD manufacturers that choose to leave their transition to the last minute may be in a situation where they are unable to obtain CE certification for their devices. Subsequently, they’ll be unable to place devices on the market. Device classification is one of the first steps in this transition.

MedEnvoy can help with the transition process

We can serve as either your EU Authorized Representative or EU Importer:

• • EU authorized representative services
  • EU importer services

If you have any additional questions, get in touch.