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July 2024
This document provides comprehensive information on the classification of in vitro diagnostic medical devices under EU Regulation 2017/746. It includes an explanation of classification principles, rules, and the definitions of terms used in the classification process.
Recent Updates:
On 08 July 2024, MDCG 2020-16 revision 3 introduced several changes. A new definition for ‘kit’ has been added to clarify what constitutes a kit in the context of in vitro diagnostic medical devices. Examples provided under Rule 3(a) have been revised, and Rule 4(a) and Rule 5(c) have also been updated. Additionally, Rule 6 received a minor revision, and Annex 2 was added to provide additional guidance and information.
On 01 February 2023, MDCG 2020-16 revision 2 brought changes such as a minor revision of examples under Rule 1, and editorial changes to the examples for Class D devices under Rule 2. The general comment for Rule 3 was updated, as well as the rationale for Rule 3(j). Footnote 8 in Rule 3(m) was modified, which may affect the interpretation or application of this rule. Examples under Rule 5(b) were also revised.
On 01 January 2022, MDCG 2020-16 revision 1 included revisions to examples in Rule 5(b).
Guidance Overview:
The document clarifies the classification rules set out under Annex VII and applies to diagnostic or information society services performed on EU patients or devices put into service through distance sales. Developed by an expert group representing member state competent authorities, commission services, notified bodies, and industry, this guidance is intended to ensure the uniform application of regulatory provisions.
It discusses the classification rules for in vitro diagnostic devices (IVDDs) under Regulation EU 2017/746, which includes devices used for monitoring, screening, self-testing, and near-patient testing of various conditions and diseases. The classification of these devices depends on their intended purpose, target patient population, and the nature of the condition being tested. For example, devices for self-testing are generally classified as Class C, except for specific exceptions like pregnancy tests and glucose detection devices. Devices for near-patient testing are classified based on their intended purpose and align with other professional use devices.
General laboratory products, accessories, and instruments specifically intended for in vitro diagnostic procedures are classified under different rules. Rule 6 applies to devices not covered by Rule 15, and it addresses those whose erroneous results are unlikely to have a significant negative impact on patient outcomes. Rule 7 applies to controls without a quantitative or qualitative assigned value, classifying them as Class I. The guidance also includes examples of classifying IVDs used in combination, such as blood gas analyzers, and details how calibrators and controls are classified in the same class as the device they are controlling.
Region: European Union
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