Cliff hanger for Digital Health-Regulation in Europe

Self-certification for FDA and CE Mark-a cliff hanger

MDR:- a significant new barrier for SaMD and connected medical devices

Most current Class I Digital Health apps with medical claims under MDR will need to have Conformity Assessments performed by a Notified Body starting May 2021.

Source: BSI white paper on Software as a Medical Device

IVDR:- a humongous barrier for SaMD and connected devices IVDs

Almost all Software IVDs with medical claims under IVDR will need to have Conformity Assessments performed by a Notified Body starting May 2022.

Source: BSI

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Digital Health Executive advising pre-Series A startups in Europe and USA

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Athar Ali

Athar Ali

Digital Health Executive advising pre-Series A startups in Europe and USA

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