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Public record of evidence reviews

Public evidence reviews

Dated product evidence, the regulatory questions it raises, and a clear distinction between publication and any verified authority filing.

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Evidence review
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Regulatory questions
Dated evidence Historical and current claims are separated
Primary sources Authority and legislation links are direct
No invented outcomes Filing requires a public receipt
Questions, not verdicts Authorities decide compliance

Featured evidence reviews

Each page states what the public evidence supports, what remains unknown, and whether an authority filing is publicly verified.

EU MDR

AI Dermatologist: Skin Scanner

ACINA, UAB (current Google Play developer)

A dated review of historical AI Dermatologist screenshots, the product's changed 2026 store description, and the MDR questions that the public evidence can and cannot answer.

Key questions

  • Did the product's intended purpose at the time of capture bring the software within MDR Article 2(1)?
  • If it was medical device software, what classification followed from Annex VIII Rule 11?
  • Was notified body involvement applicable when the captured CE mark was displayed without a four-digit number?
  • +1 more
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The evidence library is growing

We publish only when the page can separate observed facts, current status, regulatory questions, and unknowns.

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