In June 2026, Euroimmun received official confirmation from TÜV Rheinland LGA Products GmbH that all of its in vitro diagnostic devices currently on the market under Directive 98/79/EG (IVDD) may continue to be marketed in the European Union. This confirmation applies to all devices for which Euroimmun had submitted a corresponding application based on EU Regulation 2024/1860, which extends the deadlines for transitioning from the In Vitro Diagnostic Directive (IVDD) to the European Regulation on In Vitro Diagnostic Medical Devices (IVDR).
This important statutory extension of the deadline means that in vitro diagnostic medical devices authorised under the IVDD can now be sold for longer than originally specified, depending on their risk class:
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- Products of risk class D: from now until the end of 2027
- Products of risk class C: from now until the end of 2028
- Products of risk class B: from now until the end of 2029
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Since 2023, Euroimmun has held a certificate for a quality management system in accordance with the IVDR. Since the regulation came into force in 2022, this has been prerequisite for marketing new in vitro diagnostic devices of risk classes B, C and D in the European Union. The certificate confirms that the manufacturer meets the comprehensive regulatory requirements.
“Many of our products have already been transitioned to meet the requirements of the IVDR. However, confirmation from TÜV of the extended deadlines provides additional planning certainty for both our customers and ourselves. It allows our products to be continued to be used for diagnostic purposes in the meantime, while they are being transitioned step by step and in a well-structured way to IVDR conformity,” says Sven Bajorat, Director of Quality Management & Regulatory Affairs from Euroimmun.
