The EU updates harmonized technical standards for medical devices, implants, medical equipment and ophthalmic material
17 Jun 2026Effective: 11 Jun 2026145 views
Who is affected:
Manufacturers, importers and distributors of medical devices in the EU
Summary
The European Commission updates the technical standards that medical devices must comply with in the EU, including implants, electro-medical equipment and ophthalmic material. It affects manufacturers and distributors in the healthcare sector.
Detailed analysis
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This Implementing Decision amends Decision 2021/1182 to update the harmonized standards applicable to medical devices in multiple categories: biological evaluation, labeling, electro-medical equipment, transfusion, ophthalmic optics, non-active implants, washer-disinfectors, prostheses and protection against sharps inj…
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OJ:L_202601231: Decisión de Ejecución (UE) 2026/1231 de la Comisión, de 11 de junio de 2026, por la que se modifica la Decisión de Ejecución (UE) 2021/1182 en lo que respecta a las normas armonizadas para la evaluación biológica de productos sanitarios, los símbolos a utilizar en las etiquetas, el etiquetado y la información a suministrar de los productos sanitarios, los equipos electromédicos, los equipos de transfusión para uso médico, la óptica oftálmica, los implantes quirúrgicos no activos, las lavadoras desinfectadoras, las prótesis y la protección contra heridas punzantes
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