The European Commission has published Implementing Decision (EU) 2026/760, updating the list of harmonized standards supporting compliance with the Medical Devices Regulation (EU) 2017/745 (MDR).
This Decision amends Implementing Decision (EU) 2021/1182 by adding references to newly revised and adopted harmonized standards, reflecting the latest scientific and technical progress.
What’s new?
The Decision introduces three harmonized standards:
- EN 13060:2025: Sterilizers for medical purposes, Small steam sterilizers
- EN 14222:2021 + A1:2025: Stainless steel steam boilers
- EN IEC 60118-0:2024: Electroacoustics, Hearing aids, Measurement of performance characteristics
Why it matters ?
Compliance with these harmonized standards provides manufacturers with a presumption of conformity with the relevant requirements of the MDR, facilitating regulatory compliance and EU market access.
The Decision entered into force on the day of its publication in the Official Journal of the European Union.
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