Europe, January 31, 2026 — The European Commission formally published Implementing Decision (EU) 2026/193 in the Official Journal of the European Union (OJEU). This decision updates the list of harmonised standards drafted in support of the Medical Device Regulation (EU) 2017/745 (MDR). It replaces older references with new 2024 and 2025 versions, covering critical areas such as neurosurgical implants, joint replacements, and biological evaluation of breathing gas pathways.
WHICH IMPLEMENTING DECISION (EU) 2026/193 STANDARDS ARE AFFECTED?
The following standards have been added or updated in the OJEU. Manufacturers of these devices should verify their compliance against these new references immediately.
Device / Process Area | New Harmonised Standard |
Neurosurgery | EN ISO 7197:2024 – Sterile, single-use hydrocephalus shunts |
Orthopedics (Hips) | EN ISO 21535:2024 – Specific requirements for hip-joint replacement implants |
Orthopedics (Knees) | EN ISO 21536:2024 -Specific requirements for knee-joint replacement implants |
General Implants | EN ISO 14630:2024 – Non-active surgical implants – General requirements |
Respiratory | EN ISO 18562 Parts 1-4 (2024) – Biocompatibility evaluation of breathing gas pathways (Risk, Particulates, VOCs, Leachables) |
Connectors | EN ISO 80369-2:2024 – Small-bore connectors for respiratory applications |
Sterilization | EN ISO 17665:2024 – Moist heat sterilization – Validation and routine control |
Clinical Investigation | EN ISO 14155:2020 + A11:2024 – Good clinical practice for clinical investigations of medical devices |
Biological Evaluation | EN ISO 10993-4:2017 + A1:2025 – Selection of tests for interactions with blood |
WHAT DOES THIS MEAN FOR MANUFACTURERS?
The publication of these references confers a “presumption of conformity”. This means that if your device conforms to these specific harmonised standards, it is presumed to comply with the relevant General Safety and Performance Requirements (GSPRs) of the MDR.
This is a critical tool for simplifying conformity assessments. However, it also means that reliance on previous versions of these ISO standards (e.g., previous versions of ISO 18562 or ISO 17665) may no longer be sufficient to claim “state of the art” compliance without additional justification.
WHEN DOES THIS APPLY?
Immediate Effect. Unlike some regulations that offer a transition period, Article 2 of this decision states that it enters into force on the day of its publication, January 30, 2026.
WHAT SHOULD YOU DO NOW?
- Gap Analysis: If you manufacture devices in the listed categories (especially respiratory or implants), compare your current Technical Documentation against the new 2024 versions.
- Update Risk Files: The new ISO 18562 series (Part 1) specifically emphasizes evaluation within a risk management process.
- Check Sterilization Validation: Ensure your moist heat sterilization processes align with EN ISO 17665:2024.