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EC Public Health · EU-wide · 3 Nov 2026 · Guidance

MDCG 2026-6: Guidance on clinical evidence for orphan IVDs

Original title: New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs

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Medical Devices & IVD

MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026)