Modular Medical Makes Progress Towards CE Mark Certification in 2026

Tuesday, Oct 28, 2025 8:37 am ET1min read

Modular Medical is progressing towards CE Mark certification under the European Union Medical Device Regulation for its Pivot insulin delivery system. The company completed its Stage 1 ISO 13485:2016 audit with no major nonconformities identified and plans to advance to its Stage 2 audit in early 2026. Successful completion of these steps is required for Modular Medical's planned commercial launch in the European Union.

Modular Medical Makes Progress Towards CE Mark Certification in 2026

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