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MDCG 2020-16 rev.5: revised IVDR classification rules guidance published (September 2026)
Published 09 Sep 2026
The Commission announced a fifth revision of MDCG 2020-16, the guidance on classification rules for IVD medical devices under IVDR 2017/746, dated 9 September 2026. The source gives only the announcement and PDF title, so the content of the changes is not described here; IVD manufacturers should review the document to confirm any impact on their device classification.
Original title: MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (September 2026)
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New MDCG guidance, implementing acts, standards and EUDAMED changes, each explained in two lines: what changed and who must act.
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