What are the new device classifications in the In vitro Diagnostic Regulation (IVDR)?
12th March 2021. Written by Harry Mingay and Dr. Rita Hendricusdottir
Following a series of scandals, most notably regarding the Poly Implant Prosthesis (PIP) Breast Implant there was a major overhaul of European medical device regulation in 2017, which lead to the publication of new Medical Devices Regulation. In vitro diagnostic (IVD) medical devices are governed under a separate regulation to all other medical devices, outlined in the new In vitro Diagnostic Regulation (IVDR) that is due to be implemented in May 2022.
The classification of IVD devices is achieved using four risk-based categories: Class A, B, C and D. These classes are based on risk levels for both individuals and society, with Class A being the lowest risk and Class D being the highest risk category. These classification rules are set out in Annex VIII of the IVDR. A more detailed breakdown of the risk-based classes is provided below.
Fig. 1: IVD Classification Examples: A set of example devices is provided for each class (click on the image to enlarge it)
Class A devices are the only category of devices which are self-certified according to the IVDR. It is estimated that under the current IVD regulation, approximately 90% of devices are self-certified, whereas the new IVDR will result in this dropping to approximately 10% of all IVD devices. Devices that will be Class A are laboratory devices, instruments and specimen receptacles intended to be used for IVD procedures.
Class B is assigned to all IVD devices automatically if the device is not specified to be a higher risk-based category by one of the classification rules. These Class B devices are assumed to have low public health risk and a moderate to low risk to personal health. Class B includes a set of self-testing devices deemed to be lower risk, including self-tests for the detection of pregnancy. It is also stated that control materials without a qualitative or qualitative assigned value are Class B (whereas all other control materials are classified according to the device that they are intended to be used with).
Class C devices cover a broad range of diseases, conditions and situations which have a high risk to personal health but low public health risk. Class C includes devices intended for screening, monitoring, and diagnosing cancer, genetic testing, and disease staging. Devices for self-testing (excluding a select few lower-risk exceptions listed in the regulation) are an additional group of Class C devices. Self-testing devices are those that are intended to be used by patients and not healthcare professionals.
Class D covers devices with a high risk to personal health and a high public health risk, including identifying transmissible agents in blood and biological materials when assessing suitability for transfusion, transplantation, or cell administration. Class D also includes blood grouping devices to identify markers for the following blood group systems: ABO, Rhesus, Kell, Kidd and Duffy.
A rule-based classification system has replaced the current list-based approach which means that IVD device manufacturers now need to correctly classify their devices before submitting for a conformity assessment. This is not required for the current legislation and can result in a dramatic increase in the complexity of an organisation's regulatory strategy. The Medical Device Coordination Group (MDCG) has recently published 'Guidance on Classification Rules for in vitro Diagnostic Medical Devices' which provides clarifications regarding specific classification rules and includes additional information to help IVD device manufacturers to correctly classify their devices.
RegMetrics provides support with classifying IVD devices (according to the new IVDR) by evaluating classification rules to determine accurate device classifications. Information from guidance documents is presented to users whenever applicable. This further supports the decision-making process for users when classifying their medical devices.