--- title: "New Harmonised Standards under MDR" description: "Commission Implementing Decision (EU) 2026/760 updates the list of harmonised standards under the MDR, adding new and revised references that support presumption of conformity." url: https://qbdgroup.com/zh-cn/regulatory-updates/new-harmonised-standards-mdr type: "Regulatory update" language: zh-cn published: 2026-06-11 author: "Kirsten Van Garsse" category: "Regulatory Update" publisher: "QbD Group" citation: "QbD Group, \"New Harmonised Standards under MDR\", https://qbdgroup.com/zh-cn/regulatory-updates/new-harmonised-standards-mdr" --- # New Harmonised Standards under MDR > Commission Implementing Decision (EU) 2026/760 updates the list of harmonised standards under the MDR, adding new and revised references that support presumption of conformity. On 01 April 2026, the Official Journal of the European Union published Commission Implementing Decision (EU) 2026/760, updating the list of harmonised standards supporting compliance with the MDR. This Decision amends Implementing Decision (EU) 2021/1182 by adding references to newly adopted and revised harmonised standards, reflecting the latest scientific and technical progress. ## Key updates New harmonised standards introduced: - **EN 13060:2025** – Small steam sterilizers for medical purposes - **EN 14222:2021 + A1:2025** – Stainless steel steam boilers - **EN IEC 60118-0:2024** – Hearing aids (electroacoustics, performance characteristics) These updates ensure that harmonised standards reflect the latest scientific and technical progress and remain aligned with MDR requirements. By applying these standards, manufacturers can continue to benefit from the presumption of conformity with applicable General Safety and Performance Requirements (GSPRs), making them a key tool for demonstrating compliance. ## What does this mean for you? Manufacturers should review whether the new or updated standards apply to their devices and assess the impact on design, testing, clinical evaluation, and labelling. Technical documentation and ongoing projects should be updated where needed to reflect the latest versions of harmonised standards. --- Source: https://qbdgroup.com/zh-cn/regulatory-updates/new-harmonised-standards-mdr — © QbD Group. Quote freely with attribution and a link back.