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  2. CE marking - Wikipedia

    en.wikipedia.org/wiki/CE_marking

    CE marking example on a mobile phone charger. The presence of the logo (from French, "conformité européenne" meaning "European conformity") [2] on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.

  3. Notified body - Wikipedia

    en.wikipedia.org/wiki/Notified_Body

    CE Mark. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.

  4. European Organisation for Technical Approvals - Wikipedia

    en.wikipedia.org/wiki/European_Organisation_for...

    Once a building product has an ETA certificate, it can display the CE mark [2] and can be sold Europe wide. ETAs are a European alternative to national agrément certificates (for example, the British Board of Agrément). The first ETA was issued in 1998 by the DIBt in the Liechtenstein.

  5. European Union Intellectual Property Office - Wikipedia

    en.wikipedia.org/wiki/European_Union...

    The Office is in charge of managing the registration of the EU trade mark and the registered Community design and offers businesses and citizens exclusive rights for trade mark and design protection throughout the European Union (EU), with a single application. Every year, it registers an average of 135,000 EU trade marks and close to 100,000 ...

  6. European Authorized Representative - Wikipedia

    en.wikipedia.org/wiki/European_Authorized...

    As clarified in the Medical Devices Directive — Directive 93/42/EEC [4] — it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities.

  7. St. Jude Medical Announces CE Mark Approval of ViewFlex ... - AOL

    www.aol.com/news/2013-01-17-st-jude-medical...

    St. Jude Medical Announces CE Mark Approval of ViewFlex Xtra ICE Catheter New catheter provides real-time, high-resolution ultrasound images of blood flow and cardiac anatomy when paired with the ...

  8. Type approval - Wikipedia

    en.wikipedia.org/wiki/Type_approval

    The CE mark found on the back of many electronic devices does not mean that the product has obtained type approval in the European Union. The CE mark is the manufacturer's declaration that the system/assembly meets the minimum safety requirements of all the directives (laws) applicable to it, and of itself, does not signify any third party ...

  9. Italian Device Registration - Wikipedia

    en.wikipedia.org/wiki/Italian_Device_Registration

    An example of such local implementation of the Directive is now present in Italy. Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process.

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