Articles Tagged: Harmonized Standards

Commission Implementing Decision (EU) 2026/193 has been published, introducing a total of 12 new harmonised standards. These standards span a broad range of areas, including neurosurgical implants, sterilisation of healthcare products, and the biological evaluation of breathing gas pathways used in healthcare applications. The full list of harmonised standards can be seen listed below; Compliance ...

On October 17, 2025, the EU Commission published the Commission Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182. This new decision confirms the adoption of harmonized standards for several categories of medical devices, specifically surgical clothing and drapes, medical face masks, and sterilizers for medical purposes. The decision outlines the following standards, which ...