With the introduction of the EU Regulation 2017/746 on in-vitro diagnostics (IVDR), in-vitro diagnostics (IVD) are also assigned to certain risk classes. This has far-reaching consequences: Among other things, the risk class has an impact on the conformity assessment procedure, certification audits and the market launch.

So that your IVD product is not assigned to an unnecessarily high risk class, this article gives you an overview of

1. Why the correct classification is important a) IVDD becomes IVDR: What that means for classification

In May 2022, the IVDD, the previous directive 98/79 / EC on in vitro diagnostic medical devices, will be replaced by the IVDR. This gives the IVD classification a new status.

Under the IVDD one could in principle not speak of a classification, because this EU directive was missing an essential component: There were no classes at all. Instead, the IVDD included lists of critical markers.

The IVDR is now introducing a rule-based classification system with risk classes A to D. Firstly, this will lead to significantly more monitoring by notified bodies and, secondly, will cause discussions in audits and when checking product files. Estimates amount to an increase in the monitoring rate from the current 20% to at least 80%.

Fig. 1: In the future, significantly more IVDs will be assessed by notified bodies. This estimate is based on consistent statements from Notified Bodies and independent international experts . It also corresponds to the view of the Johner Institute.

The future IVDR will include far more products than before under the IVDD.

This applies in particular

  • IVD software,
  • therapy-accompanying diagnostics, so-called companion diagnostics (CDx) and
  • Products that make predictions, i.e. determine predictive values such as risk values for a certain disease (this applies above all to genetic tests).
b) Consequences of wrong classification

If the classification is incorrect, there may be deviations in the audit and product testing by the notified body. In the even worse case, an authority classifies the product in an unnecessarily high class, which inevitably leads to a delay in the market launch. In addition, competitors can question the classification and hinder the marketing of the products by means of injunctive relief.

It is therefore crucial that all parts of I.


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