The European Commission has published Implementing Decision (EU) 2026/193 of January 28, 2026, updating the list of harmonized standards applicable to Regulation (EU) 2017/745 on medical devices (MDR)
This decision introduces 12 new harmonized standards, bringing the total number of harmonized standards published under the MDR to 48.
See: Implementing Decision (EU) 2026/193 of January 28, 2026
🦴 1. Implants and non-active surgical implants
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EN ISO 7197:2024
Neurosurgical implants — Sterile, single-use shunt systems for hydrocephalus (ISO 7197:2024) -
EN ISO 14630:2024
Non-active surgical implants — General requirements (ISO 14630:2024) -
EN ISO 21535:2024
Nonactive surgical implants — Joint replacement implants — Specific requirements for hip joint replacement implants (ISO 21535:2023) -
EN ISO 21536:2024
Non-active surgical implants — Joint replacement implants — Specific requirements for knee joint replacement implants (ISO 21536:2023)
These harmonization measures are fundamental for implant manufacturers, particularly with regard to the general safety and performance requirements (Annex I of the MDR).
🧪 2. Biological Evaluation and Biocompatibility
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EN ISO 10993-4:2017
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) -
EN ISO 10993-4:2017/A1:2025
Amendment regarding blood interaction testing -
EN ISO 18562-1:2024
Evaluation of the biocompatibility of respiratory gas pathways used in healthcare — Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) -
EN ISO 18562-2:2024
Part 2: Tests for particulate matter emissions (ISO 18562-2:2024) -
EN ISO 18562-3:2024
Part 3: Tests for emissions of volatile organic compounds (ISO 18562-3:2024) -
EN ISO 18562-4:2024
Part 4: Tests for substances releasable into condensate (ISO 18562-4:2024)
The harmonization of these standards strengthens the requirements applicable to devices that come into contact with blood and to devices incorporating respiratory gas pathways, as part of an integrated risk management approach.
🏥 3. Clinical Evaluation
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EN ISO 14155:2020
Clinical investigation of medical devices for human subjects — Good clinical practice (ISO 14155:2020) -
EN ISO 14155:2020/A11:2024
This harmonization confirms the central role of ISO 14155 in demonstrating compliance with the MDR’s requirements regarding clinical investigations (Chapter VI and Annex XV).
🔥 4. Steam sterilization
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EN ISO 17665:2024
Sterilization of health products — Moist heat — Requirements for the development, validation, and routine monitoring of a sterilization process for medical devices (ISO 17665:2024)
This standard serves as a key reference for manufacturers of devices supplied in a sterile state and for the validation of steam sterilization processes.
🔌 5. Small-sized connectors for liquids and gases
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EN ISO 80369-2:2024
Small-diameter connectors for liquids and gases used in healthcare — Part 2: Connectors for respiratory applications (ISO 80369-2:2024, corrected version June 2025)
This standard is intended to prevent connection errors, a major patient safety issue, particularly in respiratory applications.
🤝 Support
Isocèle Conseil assists manufacturers in analyzing the regulatory and technical impact of these new harmonized standards. If you have any questions regarding the application of these new harmonized standards to your devices—or, more generally, regarding our regulatory monitoring services—please do not hesitate to contact us.