Source: https://www.emergobyul.com
A notified body is an entity appointed by a member state of the European Union to assess the safety and effectiveness of products before they are placed on the market. Notified bodies must submit applications to become designated under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). A complete listing of the notified bodies that are officially designated is maintained on the NANDO (New Approach Notified and Designated Organizations) database.
A notified body reviews and assesses a manufacturer’s quality management system and technical documentation to determine whether the medical device conforms to EU regulations. If the documentation meets the necessary requirements, the notified body will issue a certificate allowing the manufacturer to place a CE mark on the medical device and market and sell the product.
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