Free previewLesson 3 of 106 min
This is Article 3 of Regulation (EU) 2021/2226 — as amended by (EU) 2025/1234 — turned into a decision tree. Sabine sorted ACME Medical's entire catalogue with these two questions. Answer for one of your own devices, then try the other paths: each one ends in a different legal outcome.
Regulation (EU) 2021/2226 hangs off the MDR — so the first question is always what kind of product you have.
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