The Medical Device Coordination Group (MDCG), an advisory body of the European Commission focused on the improvement of the regulatory framework for medical devices, has published guidance on classification rules for in vitro diagnostic medical devices (IVDs). The document is dedicated to certain classification aspects under the In Vitro Diagnostic Medical Devices Regulation (IVRD) 2017/746 – the new EU-wide regulation on IVDs which soon will replace the appropriate EU Directive.
Regulatory Background
The present MDCG guidance is intended to provide additional clarifications on the classification rules to be applied for in vitro diagnostic medical devices under the new regulatory framework. The document has been developed by the MDCG experts assisted by the representatives of the industry and notified bodies. The MDCG has issued the present guidance in order to ensure a unified approach to the way the IVD classification rules would be applied. The guidance is addressed to medical device manufacturers, notified bodies, and health institutions engaged in operations with the in vitro diagnostic medical devices. The document describes the way the medical devices should be classified before placing them on the market and making available to the customers.
Due to its legal nature, the document describes the general approach to IVD classification, while its actual implementation should be based on the special regulations to be issued by the European Commission in order to ensure that all the parties involved in operations with IVDs are using the same approach to classification-related matters.
The MDCG provides the definitions of the most important terms and concepts used in the context of the IVD classification including, inter alia, the following ones:
- Confirmatory devices – devices which are intended to be used to confirm a result obtained when using the first-line assay,
- First-line device – a device intended to detect an analyte,
- Devices for monitoring – the ones used to measure the analyte levels in order to adjust treatments when necessary,
- Devices for screening – the ones used to detect the presence of the disease in a specimen,
- Devices for self-testing – the ones initially intended to be used by laypersons without the appropriate knowledge or background.
IVD Classification Principles
As set forth by the In Vitro Diagnostic Medical Devices Regulation, all IVDs should be classified into four classes: A, B, C, and D respectively, depending on the intended purpose and risks associated thereto. Thus, the classification rules in general employ the risk-based approach. It is important to mention that the class of a medical device should be considered not only when applying for the initial marking approval to be granted before placing the device on the market, but also on the further steps associated with post-market surveillance. In particular, the post-market requirements for Class C and D medical devices are stricter than ones applicable to the low-risk medical devices.
Under the general rule, the approach to medical device classification is based on the intended purpose of the device as specified by its manufacturer, including the information indicated in the labeling of the device, the instructions for use, and other materials supplied with the medical device or used for marketing purposes (e.g. promotional or sales materials).
According to the general rule, the medical device manufacturer shall clearly indicate the purpose the device is intended for. In case if due to the nature of the device and its specific features it could be used for a purpose another from the one indicated by the manufacturer, the latter should include additional restrictions and limitations, providing that such use is associated with a higher risk and requires changes to the classification of the device. Such limitations should be included in the instructions for use and technical documentation.
The MDCG additionally emphasizes, that in some cases even the medical devices having the same design, composition, and construction could be assigned to different classes under the risk-based classification in case if their intended purposes are different. In case if several risk classes are applicable, the highest one should be applied. That is why it is important for the medical device manufacturer to indicate the exact intended purposes of the medical device.
The MDCG guidance also addresses the matters associated with the classification of the software intended for medical purposes – medical device software (MDSW). According to the document,
- If the software is intended to operate e medical devices, it should be assigned to the same class as the device itself,
- If the software is intended to be used independently of any medical device, it shall be subject to the appropriate classifications depending on the risks associated with its use the same way as other medical devices.
The present guidance also contains the references to the appropriate MDCG guidance on Qualification and Classification of Software under the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746.
Explanation of the IVDR Classification Rules
In order to assist medical device manufacturers and other parties involved in applying the IVDR classification rules, the MDCG also provides detailed explanations and clarifications. The document also provides certain examples of classification rules to be applied for in vitro diagnostic medical devices.
According to the document, the medical devices intended for one of the purposes listed below should be assigned to Class D.
- Medical devices intended to detect the presence of a transmissible agent in blood, cells, tissues or organs, or other derivates, when assessing their suitability for transfusion, transplantation or cell administration,
- Medical devices intended to detect the presence of a transmissible agent causing a life-threatening disease,
- Medical devices intended to determine the infectious load of a life-threatening disease, providing that the information received is vitally important for the further treatment process.
Class C medical devices include the ones intended to be used for blood grouping or to determine blood group compatibility or other compatibility-related aspects. The same class also includes the in vitro diagnostic medical devices intended to detect the presence of an infectious agent without a high risk of propagation, or the one associated with the significant risk of incurring a severe disability.
The medical devices intended to be used for pre-natal screening of women for the purpose of determining their immune status towards transmissible agents are also Class C IVDs. For the purpose of this IVD classification rule, the term “immune status” means the presence, absence, or level of an immune response acquired by the women following an infection or vaccination. This category includes the in vitro diagnostic medical devices intended to detect a wide range of viruses. It is also important to mention that the same category covers the IVDs intended to determine infective disease status or immune status, providing that such information would be used when making clinical decisions.
Summarizing the information provided here above, the MDCG guidance on IVD classification rules highlights the most important aspects associated with the classification of in vitro diagnostic medical devices. According to the document, the risk-based approach employed by the IVDR prescribes that the appropriate class should be determined depending on the intended purpose of the medical device in question specified by the medical device manufacturer.
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