Update of the European standard for sterilization of medical devices
10 Nov 20262 views
Who is affected:
Manufacturers and distributors of medical devices in the EU
Summary
The EU updates the harmonized technical standard that regulates how medical devices must be sterilized. It affects manufacturers and distributors in the healthcare sector.
Detailed analysis
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The European Commission amends Implementing Decision 2021/1195 to update the harmonized standard applicable to the sterilization of products intended for healthcare assistance. This update requires manufacturers to review and adapt their sterilization processes to comply with the new harmonized technical requirements. …
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Implicaciones prácticas, plazos y recomendaciones específicas para tu sector.
OJ:L_202602481: Decisión de Ejecución (UE) 2026/2481 de la Comisión, de 9 de noviembre de 2026, por la que se modifica la Decisión de Ejecución (UE) 2021/1195 en lo que respecta a la norma armonizada para la esterilización de productos para asistencia sanitaria
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