Noctua Care obtains medical device certification in the European Union
CE marking confirms conformity under the EU Medical Device Regulation.
Written by Noctua Care1 min read
PARIS, March 2026. Noctua Care is now a medical device in the European Union. The company has obtained CE marking under the EU Medical Device Regulation, and the device is registered in EUDAMED.
Certification confirms the rigour of the company’s development approach and reinforces its commitment to building high-quality digital health solutions. Practically, it enables healthcare professionals to recommend Noctua Care with confidence and allows patients to be supported in managing their cardiovascular risk factors within a regulated framework.
Conformity was established against the technical standards governing medical device software: IEC 62304 for software lifecycle processes, ISO 14971 for risk management, and IEC 62366-1 for usability engineering.
Certification is a precondition for the reimbursement pathways that determine access. In France, the PECAN early-access scheme requires CE marking; in Germany, the BfArM DiGA fast-track requires it as a threshold condition.
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