notifiedbody

A notified body is an organization designated by a member state of the European Union (EU) to assess the conformity of certain products before they are placed on the market. These organizations play a critical role in ensuring that products meet specific legal and safety requirements outlined in EU legislation, particularly under directives related to medical devices, in vitro diagnostic devices, and other regulated products.

Notified bodies are responsible for carrying out conformity assessments, which may include product testing, inspection of manufacturing facilities, and review of technical documentation. Their evaluations help determine whether a product complies with applicable EU directives, enabling manufacturers to affix the CE mark, which signifies conformity and allows free trade within the EU single market.

The designation of a notified body is granted by a member state's national authorities after an assessment of its legal, technical, and organizational competence. Once designated, notified bodies operate under strict regulatory oversight to maintain high standards of evaluation and ensure consumer safety.

The list of designated notified bodies is publicly available through the EU's NANDO (New Approach Notified and Designated Organisations) database. Notified bodies are typically specialized in particular types of products and must undergo regular audits to maintain their status.

In summary, notified bodies are essential components of the EU regulatory framework, providing independent conformity assessment services that facilitate the safe and compliant introduction of regulated products into the European market.