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EU MDR Class 3

AI Dermatologist: Skin Scanner

IAC Search and Media Europe, Ltd.

A consumer skin-diagnosis app marketed to detect melanoma and skin cancer, placed on the EU market as an unregistered Class III medical device: no Notified Body conformity assessment, no Instructions for Use or label, no UDI or EUDAMED registration, and a CE mark shown without a Notified Body number.

Key violations

No Notified Body conformity assessment for a Class III device (MDR Art. 52; Annex IX, or Annex X with Annex XI)
No Instructions for Use and no product label (MDR Art. 10.11, Annex I, Section 23)
No Unique Device Identifier and no EUDAMED registration (MDR Art. 10.7 and Art. 27)
+3 more

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