14.02.2023
To the attention of manufacturers, notified bodies, healthcare institutions and all stakeholders in the field of in vitro diagnostic medical devices
We hereby inform you that, on 10 February 2023, the European Commission published the 2nd revision of the MDCG 2020-16 Guidance: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
The changes brought with the 2nd revision of the guidance refer to minor changes to the examples, the addition of Annex 2 (diagram to help determine the classification of an IVD as CDx).
This guidance, regarding the application of Regulation (EU) 2017/746 for in vitro diagnostic medical devices addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarification on the classification rules set out in Annex VIII. This classification guidance also applies to companies providing informational or diagnostic services to EU patients or devices commissioned through distance selling.
The main purpose of this document is to provide guidance to manufacturers, notified bodies and healthcare institutions on how to classify an IVD before it is placed on the market, on how to make it available on the market or put it into service in the Union.
It is also intended to inform regulatory authorities and other interested parties when the assessment of the class assigned to an IVD is done by a manufacturer or a healthcare institution.
Therefore, and only upon request of a Member State, or on its own initiative, the Commission, after consulting the Medical Device Coordination Group (MDCG), decides, by means of implementing acts, on the application of Annex VIII to a particular device, or category or group of devices, in order to establish the classification of these devices (Article 47 (3-4) of the IVDR).
The European Commission announcement is available here: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-16-rev2-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2023-02-10_en
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