On 8 Jul 2024, the European Commission (EC) published their third revision of MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. In addition to adding a definition for ‘kit,’ most of the updates relate to clarifying the IVD classification rules for self-testing devices (Rule 4(a)) and specimen receptacle devices (Rule 5(c)). The updates provide much needed clarifications to help navigate various configurations of specimen receptacles and kits for specimen collection, including when used by lay persons where lay persons must take specified actions, when included as a component in a test kit, and when used intended for use in combination with other devices. If you manufacture these types of devices, take time to review the new updates to ensure your devices and any devices in development remain appropriately classified under the IVDR.
The updates made to MDCG 2020-16 Rev. 3 are detailed in the table below by document section.
How can Qserve help?
Navigating the complexities of the updated MDR and IVDR regulations can be challenging, but Qserve is here to support you every step of the way. Our expert team can assist with classification, CE marking, and ensuring compliance with all regulatory requirements. Whether you need guidance on the transition timelines, help with notified body applications, or support with any aspect of regulatory affairs, Qserve offers tailored solutions to meet your needs. Contact us today to ensure your products remain compliant and continue to meet the highest safety standards.