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MDCG 2021-24 Rev.1: updated guidance on classification of medical devices (April 2026)
Published 20 Apr 2026
The Commission published Rev.1 of MDCG 2021-24 on classification of medical devices, dated April 2026. Changes include clarified invasiveness wording for implantable devices, updated tables for Rules 2, 8, 10, 12, 16 and 22, new notes for Rule 8 and Rule 22, and updated practical notes for Rules 8, 9, 10 and 22. Manufacturers should check their classification rationales and technical documentation against the revised rules that apply to their devices.
Original title: Update - MDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 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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