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MDCG 2020-16 — Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Regulatory guidance

Rev. 5

Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Published Sep 1, 2026

Reference

MDCG 2020-16

Source

MDCG

Topic

In Vitro Diagnostic medical devices (IVD)

Published

Sep 1, 2026

Revision

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