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The CE Mark for Medical Devices is a mandatory certification that indicates a medical device complies with the safety, health, and environmental protection standards set by the European Union. It is required for medical devices to be sold or distributed in the European Economic Area (EEA). Obtaining a CE mark demonstrates that the device meets the requirements outlined in the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on the type of device.
The process involves a thorough conformity assessment, which may include testing, clinical evaluation, and quality management system certification by a Notified Body. The CE mark assures healthcare providers and patients of the product's safety and effectiveness. Manufacturers must also ensure proper labeling, post-market surveillance, and adherence to regulatory updates. With the CE mark, medical devices can enter the EEA market, offering opportunities for global expansion and enhancing trust among users.