CE marking

CE marking from LNE G-MED, Notified Body for Medical Devices

By: LNE G-MED, Notified Body for Medical Devices  06/24/2016
Keywords: Medical Devices, Ce Marking

Before you can offer your medical products to nations within the European Union (EU) and the European Free Trade Association, you must first satisfy the requirements for CE Marking, a conformity mark that signifies a product has met all criteria of the relevant EU directives, especially in the areas of Safety and Performance. Gain market access to Europe LNE/G-MED North America can assess a wide variety of Medical Devices under the following relevant Directives: • Active Implantable Medical Devices (AIMD) (90/385/EC modified by the directive 2007/47/EC) • In Vitro Diagnostic Medical Devices (IVDD) (98/79/EC) • Medical Devices Directive (MDD) (93/42/EEC; modified by 2007/47/EC), including: Combination Products Electro-Medical Devices LNE/G-MED is the sole French notified body for the European Directives covering medical devices. It is notified by the French authorities (identification no. 0459) to the European Union member states and the European Commission for the following Directives: Directive 90/385/EEC covering active implantable medical devices modified by the directive 2007/47/CE Directive 93/42/EEC covering medical devices modified by the directive 2007/47/CE Directive 98/79/EC covering in vitro diagnostic medical devices Directive 2000/70/EC covering medical devices incorporating stable derivate of human blood or human plasma Directive 2003/32/EC covering medical devices utilizing tissues of animal origin Its notification covers: All categories of medical devices All conformity assessment procedures: - type approval - approval of quality management systems - EC verification

Keywords: Ce Marking, Medical Devices

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One of Europe’s Largest Testing Facility. Offer a complete range of standardized tests or customize tests for characterization. Electromagnetic Compatibility (EMC), Electrical Safety, CB Scheme, Charpy reference specimens.


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Product Certification and Quality Management System (QMS) services. A complete certification package to save you the time and costs. CE mark, Active Implantable Medicale Devices, In Vitro Diagnostics, Single Audit Program, ISO 13485, ISO 9001.