Jun 2026: New Harmonized Standards Published

May “In All Other News”: swissdamed Webinar, AI Act Postponed, & More

2 June 2026

Appendix to MDCG 2021-5: Transitioning to the New ‘EU REP’ Symbol

22 June 2026

Table of Contents

MDR Harmonized Standards

The link is available: HERE

Five standards were updated, and 14 standards have been newly harmonized under the MDR.

Notably, EN ISO 15223-1:2021 has been updated to reflect the new symbol format for the term “Authorized Representative”. The Commission has published a guidance document on this change (MDCG 2021-5 rev.1 – Appendix), which Casus will breakdown in a separate regulatory update.

The following Casus resource has been updated accordingly: Consolidated List of EU MDR/IVDR Harmonized Standards & Common Specifications

Updated Standards

Reference number of the standard	Title of the standard
EN ISO 10993-23:2021	Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) EN ISO 10993-23:2021/A1:2025
EN ISO 10993-12:2021	Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993 12:2021) EN ISO 10993-12:2021/A1:2025
EN ISO 15223-1:2021	Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021) EN ISO 15223-1:2021/A1:2025
EN IEC 60601-2-83:2020	Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment EN IEC 60601-2-83:2020/A11:2021 EN IEC 60601-2-83:2020/A1:2025
EN ISO 10993-17:2023	Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) EN ISO 10993-17:2023/A1:2025

New Standards

Reference number of the standard	Title of the standard
EN ISO 1135-4:2025	Transfusion equipment for medical use – Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2025)
EN ISO 1135-5:2025	Transfusion equipment for medical use – Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2025)
EN ISO 10993-1:2025	Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025)
EN ISO 10993-5:2009	Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) EN ISO 10993-5:2009/A11:2025
EN ISO 12870:2025	Ophthalmic optics – Spectacle frames – Requirements and test methods (ISO 12870:2024)
EN ISO 14607:2025	Non-active surgical implants – Mammary implants – Specific requirements (ISO 14607:2024)
EN ISO 14889:2025	Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2025)
EN ISO 15883-1:2025	Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
EN ISO 15883-2:2025	Washer-disinfectors – Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024)
EN ISO 15883-3:2025	Washer-disinfectors – Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024)
EN ISO 15883-7:2025	Washer-disinfectors – Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025)
EN ISO 22675:2025	Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods (ISO 22675:2024)
EN ISO 23908:2025	Sharps injury protection – Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration – Requirements and test methods (ISO 23908:2024)
EN 60601-1:2006	Medical electrical equipment – Part 1: General requirements for basic safety and essential performance EN 60601-1:2006/A13:2024

IVDR Harmonized Standards