Urgent decision on telemedicine: Medical device certification class IIa

In a precedent-setting case for asynchronous telemedicine, a higher regional court demands Class IIa medical device certification. Our medical devices have already had Class IIa and IIb medical device certification since 2021.

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"Software intended to provide information used to make decisions for diagnostic or therapeutic purposes [is] class IIa," says Rule 11, the new European Medical Device Regulation (MDR), which applies from 26 May 2021. Large telemedicine offers from some health insurance companies cannot show IIa certification so far - but not so the products of NEXUS / CHILI GmbH. Since 2021, our medical products have medical device certification of classes IIa and IIb.

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