Commission guidance page updated: MDCG guidance list covering Annex XVI, borderline, classification, clinical investigation and COVID-19

Published: 17 Jun 2026

The Commission's MDCG guidance page lists current documents under MDR/IVDR, including new or revised items: MDCG 2021-24 rev.1 on classification (April 2026), the Manual on borderline and classification v5 (April 2026), and the background note on its use under the Directives (April 2026). The page also lists MDCG 2024-13 on ethylene oxide (October 2024) and MDCG 2022-5 rev.1 on borderline with medicinal products (October 2024). Guidance is non-binding; manufacturers should check the revised classification and borderline documents against their product portfolio.

Original title: New guidance document on the “EU REP” symbol for authorised representatives

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