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CE認証機関の公式リスト

欧州連合認証機関の公式リスト。 必ず、更新された元のリストを参照して確認してください。

  • どの研究所または企業が認定を受けているか(そして現在も認定を受けているか)?
  • 認定されている分野(研究所や企業は、特定の試験、規格、または製品についてのみ認定されている)

あ しなければならない, easily accessible and perfectly searchable. Never use copies on this list on other sites to insure up-to-date.

分野: 規制関連業務、品質工学、医療機器、製品コンプライアンス、電子機器。
Free alternative to NANDO database, Emergo by UL, Qarad.
CE Notified Bodies Full Official List compared with NANDO database, Emergo by UL and Qarad
CE認証機関の公式リストNANDO databaseEmergo by ULQarad
情報源の性質: The European Commission notified bodies search in the Single Market Compliance Space (SMCS). It is the authoritative register of which organisations are notified and for which tasks. It is a database, not a service.情報源の性質: The earlier New Approach Notified and Designated Organisations information system of the European Commission. Its lists show identification numbers and the tasks each body is notified for, organised by legislation.情報源の性質: A regulatory consultancy, not a register. Its notified body support service helps select a notified body and prepares MDR and IVDR audit applications.情報源の性質: A consultancy part of the QbD Group, focused on regulatory affairs and quality systems for in vitro diagnostics and medical devices. It is not a register of notified bodies.
状態: Current system. According to a Czech notifying authority, NANDO and the Noise database were merged into SMCS, and notifications are now entered through SMCS Input.状態: Merged into SMCS at Commission level. The Commission page on notified bodies still describes NANDO as the place where lists are published, so the NANDO name may remain in use for the lists.状態: Commercial service under the Emergo by UL name, following the acquisition of Emergo by UL.状態: Active company, in the IVD and medical device field since 1986 according to its site.
Data content and scope: Identification number, designation, and the scope of accreditation per body. The scope matters because a body is only notified for certain tests, standards or products, so a name alone is not enough.Data content and scope: Bodies designated by EU and EFTA countries and by countries with mutual recognition agreements or PECA protocols, listed per directive or regulation.Data content and scope: Selects notified bodies according to product type, accredited scope and experience, and states which bodies hold MDR designation. A full public list is not given on the service page.Data content and scope: Documentation and consulting: CE marking, technical documentation, performance studies, authorised representative and PRRC services. Notified body information is not offered on the home page.
費用とアクセス: Free public search. Always check this source directly rather than copies on other sites, which may be outdated.費用とアクセス: Free public lists.費用とアクセス: Paid consulting, priced per project. No prices are shown on the service page.
いつ選択すべきか: Choose it to verify that a body is still notified and for exactly which scope before signing a conformity assessment contract.いつ選択すべきか: Choose it only when an older link or document points to it and the content needs to be matched with the SMCS entry.いつ選択すべきか: Choose it when a manufacturer needs help to select and approach a notified body and to prepare the application.いつ選択すべきか: Choose it for IVD regulatory documentation and representation tasks rather than for body verification.

取り上げるトピック: CE認証機関、認定、欧州連合、公式リスト、試験規格、製品認証、適合性検証、試験所認定、規制要件、認証機関ステータス、市場アクセス、適合性評価、ISO/IEC 17025、EN ISO/IEC 17021、ISO 9001、ISO/IEC 17020、およびEN 45011。

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