CE Technical File or Design Dossier Compilation and ReviewĪ CE Marking Technical File or Design Dossier (Class III) is a comprehensive description of your device intended to demonstrate compliance with European requirements. Once completed, it must be made available to European Competent Authorities upon request. Your IVD technical file must include information about your design, intended use, risk assessment, and route to conformity with IVDD requirements. IVD manufacturers must compile a technical file or design dossier showing compliance with 98/79/EC. Experienced technical file preparation for IVD companies While the CE process for IVDs is similar to that of medical devices, there are some key differences. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC), and that the device may be legally commercialized in the EU. European CE Marking for In-Vitro Diagnostic (IVD) devicesĬE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.ĬE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in 32 European countries. To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product.
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