The In Vitro Diagnostic Regulation (IVDR) has introduced a new era for IVD manufacturers, introducing a risk-based classification system that is fundamentally different from its predecessor, the IVDD. This shift from list-based categorization to risk classes is a significant change, and understanding these classes is critical for compliance.
The IVDR risk classes, namely A, B, C and D, are determined based on the potential risk to patients. These classes range from low-risk devices, such as buffer solutions (Class A), to very high-risk devices, such as tests that detect life-threatening infectious agents (Class D). The classification rules for these risk classes are detailed in Annex VIII of the IVDR.
Class A includes devices that pose a low risk to both public health and individuals. This class includes general laboratory equipment, instruments, and sample containers such as buffers, washes, and culture media. The conformity assessment procedure for these products is performed by the manufacturer, making Class A the only category that doesn't require the involvement of a Notified Body.
Class B is the default classification for all IVD devices not specifically covered by other classification rules. This class includes low to moderate risk devices such as clinical chemistry tests, some specific self-testing IVDs such as pregnancy tests, fertility tests and cholesterol tests. Conformity assessment for Class B and above always requires the involvement of a Notified Body.
Class C covers a diverse mix of high-risk IVD devices that may present a moderate to high personal health risk, but a lower public health risk. This class includes situations where failure to diagnose could be life-threatening, such as tests for infectious diseases and cancer. Conformity assessment for Class C devices may be carried out in accordance with Annex IX, Chapters I and III, or in combination with Annex X and Annex XI.
Class D includes devices associated with life-threatening conditions in general and infectious agents in blood and biological materials intended for transplantation or reimplantation into the body in particular. These tests represent a high personal and public health risk. The conformity assessment procedure for Class D is carried out according to Annex IX or in combination with Annex X and Annex XI.
The IVDR classification of a device determines the regulatory requirements it must meet. These requirements include not only the conduct of conformity assessment procedures, but also post-market surveillance, including the obligation to report serious incidents or recalls.
The IVDR also requires the creation of comprehensive technical documentation for each product. This documentation should include a detailed description of the device, information on its intended use, and data supporting its safety and performance. The level of detail required in the technical documentation depends on the risk class of the device.
Navigating the complexities of IVDR classification can be challenging, but meddevo can help. Our software allows you to centrally manage product information for all risk classes, ensuring that your product remains compliant and that regulatory requirements are consistently met, regardless of its risk class. With meddevo, you can focus on what you do best - developing innovative IVD products - while we take care of the regulatory details.