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WHO: MeDevIS Platform and EU MDCG Guidance: Classification Rules for IVDs

The World Health Organization (WHO) has established the first global open access clearing house for medical device information, called MeDevIS (Medical Devices Information System). Using it, governments, regulators, and users can make informed decisions about the selection, procurement, and use of medical devices for diagnosing, testing and treating diseases.

MeDevIS offers 2301 types of medical devices for a range of health issues, such as reproductive, maternal, newborn, and child health, noncommunicable diseases like cancer, cardiovascular diseases, diabetes, and infectious diseases such as COVID-19.

Unlike paper-based literature searches across multiple publications, MeDevIS uses a single platform to help simplify naming the medical devices. As well as replacing paper-based literature searches, MeDevIS also helps simplify naming of medical devices across multiple publications.

The Medical Device Coordination Group (MDCG) has published the revised guidance "Classification Rules for In Vitro Diagnostic Medical Devices under Regulation" on 8th July, 2024 which provides comprehensive guidelines on the classification rules for in vitro diagnostic (IVD) medical devices under Regulation (EU) 2017/746 (IVDR). This guidance is essential for manufacturers, notified bodies, and other stakeholders involved in the regulatory compliance of IVD devices.

This guidance aims to ensure a harmonized application of the classification rules for IVD medical devices across the European Union. It aims to provide clarity and support to manufacturers and notified bodies in classifying IVD devices correctly, ensuring they meet the necessary regulatory requirements. The guidance outlines the general principles for classifying IVD devices, emphasizing the importance of accurately defining the intended use and understanding the potential risks.

Devices are classified based on their intended uses, as defined by the manufacturer. In this case, the manufacturer specifies the use for which a device is intended, as indicated on the label, in the instructions for use, on the performance evaluation, or in promotional or sales materials or statements.

The IVDR adopts a risk-based approach to classification, grouping IVD devices into four classes (A, B, C, and D) based on the potential risk to patients and public health. Class D represents the highest risk, while Class A represents the lowest.

The manufacturer must clearly indicate in the information accompanying the device that the device is intended for a specific purpose referenced in a particular classification rule that the device is intended to serve such a purpose. A device should be sufficiently specified to enable a clear attribution of the class when several classification rules or sub-rules apply. Ambiguous claims can result in a higher classification.

All implementing rules, all classification rules, and all indents are to be taken into account for the classification of an IVD or an accessory for an IVD. By following these guidelines, manufacturers and notified bodies can ensure that IVD devices are accurately classified, facilitating compliance with regulatory requirements and enhancing patient safety.


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