On January 30, 2026, the EU Commission published Implementing Decision (EU) 2026/193, which lists 12 further harmonised standards under the Medical Device Regulation (MDR).
Particularly relevant for manufacturers of medical device software is EN ISO 14155:2020/A11:2024 on clinical investigations of medical devices in human subjects (Good Clinical Practice). The amendment aligns the terminology of ISO 14155 with the MDR and thereby creates a presumption of conformity for the requirements on clinical investigations set out in Annex XV of the MDR.
You can find the implementing decision here: Implementing Decision (EU) 2026/193