In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across Europe, the Medical Device Coordination Group (MDCG) has released new guidance on classification rules. This July 8, 2024 update is the third revision of the guidance and aims to bring clarity and consistency to the classification of IVDs, ensuring that these critical diagnostic tools are regulated in a manner that reflects their risk and complexity.
The new MDCG guidance introduces revised classification rules for IVDs, which are designed to align with the European Union’s Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The IVDR represents a significant shift from the previous directive, placing a greater emphasis on risk-based classification and requiring more stringent oversight for higher-risk devices.
IVDs are classified, based on risk and intended use from lowest to highest, as A, B, C, & D.
The updated guidance introduces specific adjustments to classification rules for certain types of IVDs, such as those used for genetic testing, companion diagnostics, and infectious disease detection. These adjustments are intended to address the unique risks and regulatory needs associated with these devices. Additionally, the guidance not only explains the IVDR classification rules stake in conformity assessments, but also provides examples of the classification categories for certain IVDs.
The new guidance provides clearer criteria for classifying IVDs, focusing on factors such as the intended purpose of the device, its analytical performance, and the significance of the diagnostic information it provides. This helps manufacturers better understand how their products should be categorized and regulated. Manufacturers should review the classification of their products under the new rules to ensure compliance. Devices previously classified under different rules may now fall into a different risk category, potentially impacting their regulatory pathway.
For higher-risk IVDs, manufacturers will need to prepare more comprehensive documentation and engage with Notified Bodies for conformity assessment. This may involve additional testing and validation to meet the higher standards required for these devices. Changes to classification may also necessitate updates to labeling and instructions for use, ensuring that these documents accurately reflect the new risk classification and regulatory requirements.
Read the revised guidance here.
