Correction of errors in harmonised standards for medical devices and medical equipment in the EU
22 Jun 2026Effective: 17 Jun 202672 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
PRO
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…
PRO exclusive content
Implicaciones prácticas, plazos y recomendaciones específicas para tu sector.
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)
A correction to the new European regulation establishing the single customs code of the EU and creating a common customs authority is published. It affects all ...
Importing and exporting companies, customs agents and logistics operators in the EU
The EU sets its position to extend the CBAM (carbon tax at borders) to the European Economic Area. It affects trade in goods with Norway, Iceland and Liechtenst...
Importers and exporters of carbon-intensive products with non-EU EEA countries
A new regulation has been published in the Official Journal of the European Union. The specific content requires direct consultation of the official text.
To be determined according to the content of the official text
A new regulation has been published in the Official Journal of the European Union. The specific content requires direct consultation of the official text.
To be determined according to the specific content of the regulatory text
The EU appoints a new commander for its Atalanta naval military operation, which protects maritime security in the western Indian Ocean and the Red Sea. The pre...
Military forces participating in the EU EUNAVFOR Atalanta operation
