Revision of Standardisation Regulation 1025/2012

Posted on 03.07.2025

The EU is set to revise its Standardisation Regulation 1025/2012, as announced in the 2025 EU Competitiveness Compass. This revision aims to accelerate and simplify standard-setting processes, particularly for SMEs and startups, aligning with the 2022 EU Standardisation Strategy’s focus on global standard-setting for EU competitiveness and technological sovereignty.

The revised framework will aim to swiftly develop harmonised standards, ensuring inclusivity and balanced stakeholder participation, while also addressing transparency and access issues highlighted by recent European Court of Justice rulings.

The revision will occur concurrently with the New Legislative Framework, which relies on harmonised standards for product essential requirements in the EU single market. MedTech Europe supports and will submit feedback to this revision, viewing it as an opportunity to strengthen the European Standardisation system. This is expected to facilitate quicker access to harmonised standards, enabling easier presumption of conformity for medical devices, leading to faster patient access while maintaining high safety and performance standards for devices.

For further information, please contact Carlos Pérez Barrionuevo, Manager Medical Devices.