MDCG Guidance on IVD Classification Rules: Second Revision

Table Of Contents

The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework, has published a guidance document dedicated to classification rules for in vitro diagnostic medical devices (IVDs) under the Regulation (EU) 2017/746 (IVDR). The document provides additional clarifications regarding the applicable classification rules, as well as additional recommendations to be considered by medical device manufacturers. At the same time, it is explicitly stated that the guidance should not be considered an official EU document, nor is intended to introduce new rules or impose new obligations. The present document constitutes a second revision of the guidance initially issued by the MDCG in 2020. 

The scope of the guidance covers classification rules set forth under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices, and also addresses the aspects related to diagnostic or information society services performed on EU patients or medical devices supplied via distance sales. The purpose of the document is to introduce a unified approach in order to facilitate and streamline the regulatory procedures, ensuring and expanding the availability of medical devices in the EU Member States. 

As further explained in the guidance, the European Commission takes actions to ensure the implementation of the classification rules set forth by the IVDR. For this purpose, the Commission may adopt the appropriate implementing acts. It is also stated that the relevant scientific opinion will be duly considered by the Commission when taking such actions. 

The MDCG additionally emphasizes that any examples the guidance contains are provided for illustrative purposes only, and should not be considered exhaustive. The actual application of classification rules should be assessed on a case-by-case basis.

Terms and Definitions 

First of all, the document provides definitions of the most important terms and concepts used in the context of classification rules for in vitro diagnostic medical devices including, inter alia, the following ones: 

• First-line device – a device intended to be used to detect a marker on analyte, and which may be followed by a confirmatory assay. 
• Confirmatory device – a device intended to be used for the confirmation of a reactive results from a first line assay. 
• Marker / analyte / measurand – a substance or material, something that identifies or that is used to identity; a factor that establishes the nature of an entity or event; constituent of a sample with a measurable property. 
• Devices for monitoring are the ones used for the measurement of the analyte (measuring) levels for the purpose of adjusting treatments/interventions as required.
• Devices for screening are the ones used to detect the presence of or the predisposition to a disease, disorder, or other physiological state in a specimen from an individual, embryo, or foetus not demonstrating clinically evident symptoms. 
• Device for self-testing stands for a device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means for information society services.

Apart from the ones listed hereabove, the document provides definitions of such terms as “infective/infectious agent”, “life-threatening”, “specimen”, “instrument”, and “transmissible agent”. The document also explains the difference between the concepts of “detecting the exposure to an agent” and “detecting the presence of an agent”, and outlines the scope of medical devices covered by the concept of “devices for monitoring”. 

Principles of Classification 

In order to assist medical device manufacturers and other parties involved in interpreting the provisions of the applicable regulations prescribing the classification rules for in vitro diagnostic medical devices, the MDCG outlines the main principles of the said classification and highlights the key points to be considered for the proper interpretation. 

In accordance with the existing regulatory framework set forth under Regulation (EU) 2017/746, any and all in vitro diagnostic devices allowed for marketing and use should be assigned to one of the four classes from A to D based on their intended purpose, and also the risks associated thereto. The MDCG additionally emphasizes the importance of applying the proper risk-based classification in order to ensure the relevant rules are applied, and the level of regulatory scrutiny the device is subject to corresponds to the risks associated with its use. For instance, in the case of high-risk medical devices, the involvement of European Union reference laboratories will be required. Furthermore, the risk-based classification will also impact the applicable post-market requirements to be fulfilled in order to ensure the device operates properly when used for its intended purpose. This includes, inter alia, the appropriate reporting requirements – for example, an obligation to submit post-market surveillance reports or Periodic Safety Update Reports (PSURs).

Intended Purpose 

As it was mentioned before, the intended purpose is one of the two most important factors to be taken into consideration when determining the class of the device under the existing classification rules. As explained by the MDCG, the concept of intended use covers the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, in the performance evaluation, or in promotional or sales materials or statements. Consequently, it is vitally important to ensure the intended purpose is precisely indicated in the documentation accompanying the device. The authority also mentions that in case there is a foreseeable risk of the device in question being used for purposes falling within the scope of another classification rule, resulting in higher classification, the appropriate limitation of use should be included in the documentation accompanying the device when supplied to potential users. If the device is intended to be used for a specific purpose, this purpose should be clearly indicated by the manufacturer in order to ensure attribution to a specific classification rule. 

Application of Rules 

The document also describes the approach to be followed when applying classification rules to medical devices subject to review. In this respect, the authority emphasizes the following:

• Unless otherwise specified, the rules … apply equally to all technologies, principles of detection or analytical procedures;
• Unless specified in the classification rule, the rules apply equally to all specimen types.
• Software which drives a device or influences the use of the device shall fall within the same class as the device. 

In summary, the present MDCG guidance covers the most important aspects to be considered by medical device manufacturers and other parties involved in order to ensure the proper application of classification rules for in vitro diagnostic medical devices. The document describes the main principles to be followed and also highlights specific points requiring additional attention to be paid. 

Sources:

https://health.ec.europa.eu/system/files/2023-02/md_mdcg_2020_guidance_classification_ivd-md_en.pdf

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