The EU updates harmonized technical standards for medical devices, condoms, sterilization and health products
10 Nov 20260 views
Who is affected:
Manufacturers and distributors of health products in the EU
Summary
The European Commission updates the technical standards that various health products must comply with in the EU. It affects manufacturers of medical devices, condoms, disinfection washers and health connectors.
Detailed analysis
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This Implementing Decision amends Decision 2021/1182 to update the list of European harmonized standards applicable to health products. Affected areas include sterilization, clinical research, biological evaluation, electromedical equipment, disinfection washers, latex condoms and small-diameter connectors for liquids …
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Implicaciones prácticas, plazos y recomendaciones específicas para tu sector.
OJ:L_202602479: Decisión de Ejecución (UE) 2026/2479 de la Comisión, de 9 de noviembre de 2026, por la que se modifica la Decisión de Ejecución (UE) 2021/1182 en lo que respecta a las normas armonizadas para la esterilización de productos para asistencia sanitaria, la investigación clínica de productos sanitarios para seres humanos, los condones masculinos de látex de caucho natural, la evaluación biológica de productos sanitarios, las lavadoras desinfectadoras, los equipos electromédicos y los conectores de diámetro pequeño para líquidos y gases en aplicaciones sanitarias
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