Qualification and classification of in vitro diagnostic medical devices
This webpage provides information for in vitro diagnostic medical device (IVD) manufacturers on how to qualify their products as IVDs. It also covers the application and relevance of IVD classification rules.
Qualification of IVDs
In order for a product to qualify as an IVD, it must meet the definition of an IVD.
By carrying out an in vitro exam of a human specimen, IVDs provide information on an illness, or the likelihood of developing an illness. Article 2(2) of the In Vitro Diagnostic Medical Devices Regulation (IVDR) outlines the definition of an IVD.
Software may also meet the definition of an IVD. The Medical Device Coordination Group (MDCG) has published guidance on the qualification and classification of software under the MDR and the IVDR. This document defines the key criteria for correctly qualifying and classifying software as an IVD for IVD manufacturers.
Classification of IVDs
IVDs are divided into four risk classes which take into account their risk and intended purpose;
Class A (lowest risk),
Class C and
Class D (highest risk).
Manufacturers must correctly classify their IVDs using IVDR classification rules. Annex VIII of the IVDR outlines these rules. The risk class of an IVD will determine its performance and safety requirements as well as its route to market.
Once classified, an IVD must undergo its applicable conformity assessment procedure for it to be CE marked and placed on the EU market.
The MDCG has published Guidance on Classification Rules for in vitro Diagnostic Medical Devices. This guidance provides practical information on the application of IVDR classification rules for manufacturers.
In some cases, it may be difficult to correctly qualify or classify products. In these cases, we encourage device manufacturers to review the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This document serves as a tool for the case-by-case application of EU law.
If you would like more information on classification of IVDs, please email us at firstname.lastname@example.org.