New ISO Standards for surgery published

Commission Implementing Decision (EU) 2026/193, adopted on 28 January 2026, introduces new EN ISO standards for use in assessment of the conformity of medical devices with the Medical Devices Regulation (MDR). Compliance with the provisions of EN ISO standards that have been published in the Official Journal of the European Union as part of Commission Implementing Decisions gives rise to a presumption of conformity with related provisions of the MDR.

The EN ISO standards listed in Commission Implementing Decision (EU) 2026/193 relate to a number of surgical aspects including hip-joint and knee-joint replacement implants, neurosurgical implants, good clinical practice for clinical investigations of medical devices, and sterile, single-use hydrocephalus shunts.