Correction of errors in harmonised standards for medical devices and medical equipment in the EU
22 Jun 2026Effective: 17 Jun 202644 views
Who is affected:
Manufacturers, importers and distributors of medical devices and medical equipment in the EU
Summary
Errors are corrected in the European decision on harmonised technical standards for medical devices, medical equipment, implants and ophthalmic material. It affects manufacturers and distributors in the healthcare sector.
Detailed analysis
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This error correction adjusts the Commission Implementing Decision (EU) 2026/1231 that modifies the harmonised standards applicable to medical devices under Regulation (EU) 2017/745. The corrections affect technical standards on biological evaluation, labelling, electromedical equipment, transfusion equipment, ophthalm…
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OJ:L_202690511: Corrección de errores de la 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 (DO L, 2026/1231, 17.6.2026)
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