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Notified bodies approval marks

In addition to the CE marking affixed to a product, customers may demand a European third-party (notified body) approval mark, certification, or test report connoting a higher level of quality to ensure safety/EMC compliance. To control non-conforming products the following clause from the Official Journal of the European Communities (OJEC) applies ... [Pg.2]

EU notified bodies may accept CB Certificate for issuance of notified body Approval Mark (above). [Pg.59]

To be able to EC mark a product, the manufacturer must undergo, for each product and type of valve, a conformity assessment comprising the EC type or design examination and the assurance of the production quality system. The manufacturer must also demonstrate the quality compliances of all sub-suppliers and ensure that all critical parts (or at least pressure-retaining parts) are fully traceable and accompanied by a material certificate. Procedures to certify conformity to PED are carried out by a notified body approved by the member states of the European Community. With completion of the assessment, the manufacturer may stamp the EC mark on the product. [Pg.67]

An overview is presented of the CE marking requirements for manufacturers of medical devices, the role of EU Notified Bodies and third party approval and the provision of relevant data to the manufacturers of medical devices. [Pg.62]

Apparatus approved by a notified body (certificate of conformity, control certificate) shall be marked by the manufacturer with an Ex in a hexagon according to Fig. 3.1(a). This mark ensures the compliance of the individual apparatus with the specimen tested by the notified body and ensures that all routine tests according to the relevant Harmonized European Norms (if a certificate of conformity has been issued) or all routine tests prescribed in the control certificate have been carried out and passed successfully. According to Directive 82/130/EEC, apparatus with a control certificate shall be marked with an additional S in a circle (see Fig. 3.1 (b)). [Pg.68]

The amount of detail for approval of the device increases from Class I to Class III. In the UK submission of data and subsequent approval is through the Medical Device Agency (MDA). Devices have to be independently assessed by MDA Notified Bodies, which on approval can issue the authorised CE mark this allows unrestrained distribution across Europe. [Pg.443]

Some people believe that the reason for the popularity of German safety approvals such as the GS Mark, is that approvals were mandatory in Germany. After all, over 100,000 different products bear the GS Mark (GS = Safety Tested). Approvals and marks have, however, never been mandatory by German law for the vast majority of products and machines. Their popularity is driven by expectations in the marketplace from the product users, consumer groups, insurers, and employers. These high expectations continue today in Germany and some other countries. (See chapters on Notified Bodies and Certification [Chapter 4] and the Quality and Safety Mindset [Chapter 5].)... [Pg.8]

Not a mark, certification, or approval from European recognized third-party (e.g., notified body) ... [Pg.38]

The approval mark on the product and accompanying test report from a notified body serve two purposes. In regards to safety/EMC conformity, the test report is the manufacturer s best line of defense if the product s safety is questioned, and a reputable approval mark on the product is marketing s best sales tool As the European Commissions Guidelines on the Application of Council Directive 73/23/EEC (LVD), states ... [Pg.58]

The highest level for conformity verification and acceptance in Europe are the voluntary product safety and EMC Approval Marks, issued by European notified and competent bodies. The Approval Mark is backed by an official test report and certificate from a European accredited body (OJEC). [Pg.59]

Note To ensure compliance with all ENs and ERs for the CE marking requirements and expedite Apiaoval Marks, product manufacturers should use a national certification body (NCB) that is also a European notified body (in OJEC). Additional test samples and subsequent testing may also be reduced or eliminated for Approval submittal. [Pg.59]

The manufacturer s best line of defense is a test report and approval mark from a notified body. [Pg.67]

The European bodies (especially in Germany) issue certified approvals and marks according to clearly defined standards, which are definitive statements on their assessment results. The European approval term means that the equipment bearing an approval mark has been successfully tested and passed, but more important, approvals are perceived by users and customers as a guarantee that the equipment is safe for use (see Notified Bodies and Certification in Chapter 4). [Pg.73]

Test report. Test reports are technical records on the conformity assessment of a product according to specific standards. Test reports are concise accounts that include clause-by-clause details on the results of a product assessment, standards rationale, test data, safety/EMC construction, and critical components. Test reports are an essential tool for conformity assessment of equipment and the key element of a technical file. Test reports contain the results of the conformity assessment and need not contain confidential design information. When a EU approval mark is not affixed to the component, product, or machine in question, test reports may be requested by customers, testing bodies, or enforcement authorities for review and verification purposes. In the event that conformity is challenged, the submission to the enforcement authority of a report drawn up by a notified body (i.e., VDE/TUV) is considered an element of proof and evidence that the equipment complies with the safety/EMC objectives. [Pg.140]

Certificates and approval-marks. Visible attestations from European accredited testing and certification bodies that provide positive evidence of conformity. Approval marks are product quality marks for safety/EMC compliance. Certificates and marks are supported by verifiable and accurate test reports from EU-notified or competent bodies. Marks and certificates establish the independent verification of a product s conformity that customers may demand. Regular follow-up inspections are performed, on equipment with EU approval marks, by the certification body to ensure ongoing conformity. When issued by recognized European certification bodies, official certificates and test reports provide the ultimate defense of due diligence should a product s conformity come into question. [Pg.140]

Governments around the world approve the sale of medical devices in many different ways. In Australia the Therapeutic Goods Administration issues an Australian Register of Therapeutic Goods number to devices cleared for the market. In Canada a device licence is awarded by the Therapeutic Products Directorate. In the European Union, after receiving an EC certificate from a notified body, the manufacturer places the CE mark on the device. In Japan a shounin is issued by the Pharmaceutical and Medical Safety Bureau of the Ministry of Health, Labor and Welfare. In the United States the manufacturer of the device receives a marketing clearance (510(k)) or an approval letter (PM A) from the FDA. [Pg.211]

The CE marking is not a mark and should not be confused with a mark, certificate, or approval issued by a European recognized third-party (e.g., notified or competent body). The CE marking is a symbol of the manufacturer s declaration. [Pg.59]


See other pages where Notified bodies approval marks is mentioned: [Pg.804]    [Pg.65]    [Pg.69]    [Pg.178]    [Pg.265]    [Pg.15]    [Pg.4]    [Pg.4]    [Pg.252]   
See also in sourсe #XX -- [ Pg.56 ]




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