New Harmonized Standards Added Under EU MDR

Content

On 30 January 2026, the European Commission published Implementing Decision (EU) 2026/193, updating the list of harmonized standards supporting the Medical Device Regulation (EU) 2017/745 (MDR).

This update integrates several major revisions to essential standards that strengthen safety, performance, and compliance for medical devices, including:

EN ISO 7197:2024: Neurosurgical implants: hydrocephalus shunts
EN ISO 10993‑4:2017/A1:2025: Biological evaluation: blood interactions
EN ISO 14155:2020/A11:2024 : Clinical investigation: Good Clinical Practice
EN ISO 14630:2024, 21535:2024, 21536:2024 : Non-active surgical implants & joint replacements
EN ISO 17665:2024: Sterilization of healthcare products
EN ISO 18562 series (2024): Biocompatibility of breathing gas pathways
EN ISO 80369‑2:2024: Small-bore connectors for respiratory applications

Goal: Ensure standards reflect the latest scientific and technical progress, reinforcing the presumption of conformity under the MDR.

The decision enters into force on the day of its publication in the Official Journal of the EU.

DOWNLOAD THE IMPLEMENTING DECISION (EU) 2026/193