The European Commission has published Implementing Decision (EU) 2026/760, updating the list of harmonised standards under the Medical Devices Regulation (EU) 2017/745 (MDR). The decision amends Implementing Decision (EU) 2021/1182 and is directly applicable following its publication in the Official Journal.
From a regulatory perspective, this update reflects ongoing efforts to align harmonised standards with the latest state of the art. Following a standardisation request from the Commission, CEN and Cenelec revised existing standards to incorporate the latest technical and scientific progress. In particular, previously harmonised standards for small steam sterilizers and hearing aids were updated, and a new standard for stainless steel steam boilers was introduced. These revisions resulted in the adoption of the latest versions now cited in the Official Journal.
For manufacturers, the decision adds three updated harmonised standards that can be used to demonstrate conformity with MDR requirements and benefit from the presumption of conformity:
In practical terms, the scope of this update mainly concerns manufacturers of sterilization equipment and associated systems, as well as manufacturers of electroacoustic medical devices such as hearing aids. By applying these harmonised standards, manufacturers can more efficiently demonstrate compliance with the MDR’s general safety and performance requirements, thereby facilitating conformity assessment procedures and access to the EU market.
Manufacturers should assess whether the newly harmonised standards are applicable to their products and review any impact on their current technical documentation, testing methods, and conformity assessment strategy. Where relevant, transitioning to the updated versions can provide a clearer and more robust route to demonstrating compliance with MDR requirements. It is also advisable to monitor transition periods (if applicable) and coordinate updates with notified bodies to ensure continued alignment with regulatory expectations.
For full details, see the official publication:
https://eur-lex.europa.eu/eli/dec_impl/2026/760/oj
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