The Medical Device Coordination Group (MDCG) has published the third version of the MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. The updated guidelines provide detailed guidance to manufacturers, notified bodies and healthcare institutions on the appropriate classification of in vitro diagnostic medical devices, introducing among other things a definition of kit and examples of devices belonging to the applicable class. The document is a key source of information for ensuring uniform interpretation of the provisions of Annex VIII to the regulation (EU) 2017/746.

In July 2024, Medical Devices Coordination Group (MDCG) released the third revision of the guidance document MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. This updated document offers crucial insights into the classification of in vitro diagnostic medical devices and clarifies the classification rules outlined in Annex VIII of regulation (EU) 2017/746.

This guidance has been developed by an expert group including representatives from Member State Competent Authorities, Commission services, notified bodies, and industry. The MDCG 2020-16 rev. 3 serves as an essential resource for manufacturers, notified bodies, and health institutions, providing detailed instructions on how to properly classify an IVD medical device before it is placed on the market or put into service within the EU. Additionally, the guideline offers valuable information to regulatory authorities and other stakeholders on how to assess the class attributed to an IVD medical device by a manufacturer or healthcare institution.

Key updates in this latest revision include:

  • Introduction of a ‘kit’ definition – ‘Kit’ means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof;
  • Updated examples included Monkeypox Virus in the list of examples for Rule 3(a): Devices intended for detecting the presence of, or exposure to, a sexually transmitted agent;
  • Changes to Rule 4(a): Devices intended for self-testing – e.g. devices designed to measure calprotectin levels, where a lay person collects the stool specimen, performs the testing with a test cassette, and sends an image of the result for interpretation by a healthcare professional, are classified as class C;
  • Amendments to Rule 5(c): Specimen receptacles – additional explanation and examples added;
  • Revised examples for Rule 6: Class B devices – a minor revision of example of the device intended for the detection of Influenza A/B virus, from “non-pandemic” to “highly virulent”.

MDCG 2020-16 Rev.3 provides clarifications that improve the regulatory framework for IVD devices in the EU. This is a key document setting out detailed rules for the classification of in vitro diagnostic medical devices, which aims to resolve divergent interpretations regarding the correct classification of these devices and helps interpret the provisions of Annex VIII to the regulation (EU) 2017/746.Find out more:  https://health.ec.europa.eu/document/download/12f9756a-1e0d-4aed-9783-d948553f1705_en?filename=md_mdcg_2020_guidance_classification_ivd-md_en.pdf