Every manufacturer, distributor, and importer of IVD products, should have already read the Regulation on in-vitro diagnostics. The day of its validity is inexorably approaching, replacing the IVDD. There is little time left to implement the comprehensive requirements of Regulation (EU) 2017/746. The relevant processes should be installed by May 26, 2022, at the latest. Not only the articles on traceability or post-market surveillance can represent hurdles for the stakeholders; It should also be clarified which risk class the IVD product has in the first place – easier said than done.
The new regulation recognizes the four risk classes A, B, C, and D. The classification is based on the intended purpose and the resulting risk profile. The previous system of the IVDD, in which IVDs could be assigned to a list, no longer exists as of May 2022. The Annex VIII of Regulation (EU) 2017/746 will declare which risk class your product belongs to.
Annex VIII includes 7 classification rules, which can be used to determine the correct risk class. Subsequently, the appropriate conformity assessment procedure can be initiated. However, only class A can gain market access through self-declaration of conformity; all other classes rely on the involvement of a Notified Body in the conformity assessment procedure.
A study by the Netherlands Institute for Health and the Environment found that Notified Body participation will increase from 7% to 84%!
Although the 7 classification rules of Annex VIII are available, correct classification is not always so simple. In general, if more than one rule applies, the product is assigned to the higher risk class. To assist manufacturers and distributors, the Medical Device Coordination Group (MDCG) of the European Commission has provided a guidance document explaining the individual rules.
The MDCG document provides detailed explanations of all sections and helpful examples. For stakeholders who are not sure which risk class their in vitro diagnostic device falls into, the document is the first point of contact.
In addition, the International Medical Device Regulation Force (IMDRF) recently published another helpful document on the classification of IVDs. In 2011 the IMDRF assumed responsibility of the work from the Global Harmonization Task force and has been promoting international harmonization of medical device industry regulatory requirements ever since. The IMDRF's voluntary members are the regulatory authorities of individual countries such as Brazil, Japan, and the European Union.
While the MDCG's guidance explains the rules of the IVDR and is aimed at manufacturers and distributors in the European Economic Area, the IMDRF's document is not merely to be understood in a European context. It contains the consensus of all member states on the classification of IVDs. The IVDR is based on the document published by the IMDRF back in 2008. It applies the risk-based approach recommended by the harmonization group. In 2020, the IMDRF started to revise and update the guidance document once again and finalized and published it at the beginning of 2021. For manufacturers that do not operate exclusively within the European Economic Area, the IMDRF document provides important guidance on product classification, as many of the member countries have agreed to administer the same rules. For manufacturers with markets within the EU, it provides assistance in understanding the classification approach.
The application of the 7 classification rules of the IVDR is tedious but, in the vast majority of cases, it will lead to an unambiguous result. For an initial understanding, also regarding the question of which conformity assessment procedure can be applicable, our Poster in A0 is helpful.
Nevertheless, the classification of a product can be a bit more complicated. One problem with the IVDR classification rules is their reference to disease-related uses of IVDs. For many manufacturers this can present the issue that a number of rules are applicable at once. Point 1.9. of Regulation (EU) 2017/746 Can assist in this instance: "If several classification rules apply to the same device, the rule resulting in the higher classification shall apply."
Moreover, the IVDR is always imprecise when it comes to "high risk," "high risk of propagation" or "life-threatening diseases." The regulation fails to provide guidance on how exactly to measure high risk.
The MDCG offers some more guidance on classifying the risk of propagation: Several factors contribute to the risk of propagation of a pathogen within a population, namely:
We have compared the documents on the classification of in vitro diagnostic devices and summarized them in a graphic below. Starting from the IVDR rules, you can see what MDCG and IMDRF have to add. Also included are the helpful examples from both documents. The clearly structured chart will help you develop a deeper understanding of how to classify your in vitro diagnostic product and clear up any ambiguities. If you have any further questions, please do not hesitate to contact us. qtec has the right expert for you!
The seven rules all compiled into one table.