#32026D0760Commission Implementing Decision (EU) 2026/760 of 1 April 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilizers for medical purposes – small steam sterilizers, stainless steel steam boilers and electroacoustics – hearing aids
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This Commission Implementing Decision updates the list of harmonised European standards that provide presumption of conformity with EU medical device and personal protective equipment regulations. It specifically adds or revises standards for three categories of products: small steam sterilizers used in medical settings, stainless steel steam boilers that form part of sterilisation equipment, and electroacoustic requirements for hearing aids. By referencing the latest versions of these standards (published in the Official Journal of the EU), manufacturers can demonstrate compliance with essential safety and performance requirements more easily. The decision entered into force on 1 April 2026 and forms part of the EU’s continuous effort to keep harmonised standards current with technological and safety developments.
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Key Changes
- Amends Implementing Decision (EU) 2021/1182 by updating references to harmonised standards
- Adds or revises standards specifically for small steam sterilizers for medical purposes
- Includes updated requirements for stainless steel steam boilers used in sterilisation equipment
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Obligations
What this law requires
Manufacturers of small steam sterilizers must ensure their products comply with the harmonised European standards referenced in Commission Implementing Decision (EU) 2026/760 for presumption of conformity with EU medical device regulations
Manufacturers of stainless steel steam boilers used in sterilisation equipment must ensure their products comply with the harmonised European standards referenced in this Decision
Manufacturers of hearing aids must ensure electroacoustic performance requirements comply with the harmonised European standards specified in Commission Implementing Decision (EU) 2026/760
Manufacturers must reference the latest versions of harmonised standards as published in the Official Journal of the EU to demonstrate compliance with essential safety and performance requirements
Compliance with the harmonised standards referenced in this Decision as of 1 April 2026 (the entry into force date) must be demonstrated by manufacturers