Modular Medical announces ‘ongoing progress’ to obtain CE Mark

Modular Medical (MODD) is continuing to progress toward CE Mark certification under the European Union Medical Device Regulation. As part of this process, the Company is pleased to announce the successful completion of its Stage 1 ISO 13485:2016 audit, conducted by BSI, its Notified Body and Registrar. The audit evaluated Modular Medical’s quality management system for compliance with ISO 13485:2016 and alignment with EU MDR 2017/745 requirements, to confirm that the Company’s QMS is robust and well-documented, with no major nonconformances identified. Completion of the Stage 1 audit paves the way for Modular Medical to advance to its Stage 2 audit in early 2026 – the final step before achieving the required ISO 13485 certification. In parallel, the Company will begin preparations for its CE technical documentation review under EU MDR 2017/745, which is anticipated to commence later in 2026. Successful completion of these steps is required for Modular Medical’s planned commercial launch in the European Union. The Pivot insulin delivery system is not currently cleared for sale by the U.S. Food and Drug Administration or in any other market outside the U.S.