Changes in the European In Vitro Diagnostic Regulation

Melinda Higgins

Oct 30, 2017

Operational E 1

Changes in the European In Vitro Diagnostic Regulation


May 26th the In Vitro Diagnostic Regulations’ (IVDR 2017/746) came into force, following the official publication in early May 2017 in the Official Journal of the European Union (OJEU). The five-year countdown to the IVDR’s date of application (May 26th, 2022) has  begun. Many IVD’s changed class and their manufacturers and European Notified Bodies will have the challenge to (re-)evaluate their technical files. For most of the IVD’s it is clear according to which Rule they will end up in Class A, B or C. For some reagents, like antibodies, this is not straight forward and a challenge resulting in discussions held to come to a consensus. Where the American regulation recognizes analyte specific reagents (ASR), the new European IVDR doesn’t recognize such a group.

The Implications of IVDR

Antibodies can be seen as general laboratory reagents and in that case would be considered Class A. But do they fulfil the criteria of ‘products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination’ (2.5 Rule 5 of the IVDR)? Most of the IVD antibodies are used to classify hematological cancers. Do they fall in Class C (h) ‘to be used in screening, diagnosis, or staging of cancer’(2.3 Rule 3 of the IVDR)? And when they do so, can we register them as a group or have they to be considered individual reagents and registered like that? Questions most Notified Bodies still cannot answer, but which are important to get everything evaluated in time.

Not continuing the IVD registration of antibodies most likely will lead to the fact the antibodies will not longer be used in the hospital setting. Are there more manufacturers struggling with these questions? Would it be helpful to come together and discuss the way forward?