Notified bodies and certification

Always do right. This will gratify some people and astonish the rest. 

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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].)... 

Consultants and outside testing labs are not third parties. As mentioned, the European terms third party and notified body are interchangeable and signify Bodies Notified to the Commission, as listed in the OJEC (see Notified Bodies and Certification in Chapter 4). 

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). 

As referred to above, most of the modules involve the intervention of a third party, the so-called notified bodies. These bodies are designated by Member States as being competent to carry out the certification tasks for which they are notified. As a precondition for their notification they must fulfil the minimum criteria which are set out in the relevant directives. These conditions vary from independence, impartiality and professional integrity, to technical competence, possession of or access to necessary facilities and to liability insurance. Once notified, the Commission publishes a list of all notified bodies in the Official Journal, It is worth noting that there is free competition between notified bodies and that manufacturers can make their own choice from all notified bodies notified within the European Union. 

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)). 

If the apparatus has been type tested and certified (certificate of conformity, control certificate) according to the old article 100 directives, the identification mark of the notified body and the certificate number shall be affixed on the apparatus. In the same way, a component (with a component certificate) shall be marked. 

Notified bodies are independent testing laboratories and/or certification bodies recognized in the European Union to perform tests and issue reports and certificates on conformity. These bodies are generally referred to as notified bodies. Depending on the directive an accredited body may be referred to as a notified body, competent body, certification body, third party, or other (see Notified Bodies and Third Parties in Chapter 4). Test reports and certificates issued by accredited bodies attest to a product s or system s conformity to the relevant standards. These reports and certificates are the basis for mutual recognition of test results and build consumer confidence in a product s conformity. 

Originally conceived as a government tool for consumer protection, the idea of accredited notified bodies and product certifications has received fresh impetus from the European Commission and many trade organizations. 

European notified bodies (safety) and competent bodies (EMC) are accredited at the national level by the member states, such as in Germany at the European level accreditation occurs when notified to the Commission and listed in the Official Journal of the European Communities. These accredited bodies are sanctioned by the European Commission and the member states to interpret directives and standards, and issue test reports and certificates on conformity. When a product becomes suspect or an incident occurs, the national enforcement authority may consider a test report or certificate issued by a European body. Having the notified body mark, certificate, and test report usually shifts the onus of proof in the manufacturer s favor, since the product was evaluated and certified by European recognized experts. 

The requirements for European Community (EC)-type certification are declaration of conformity and technical documentation files for all categories of gloves. For categories II and III, there are additional requirements EC-type examination testing by approved laboratories, certified by approved notified bodies and manufacturing under a formal EC quality assurance system. 

In the case of IVDs that require the involvement of a Notified Body, data on performance characteristics, the results of performance evaluation and device certificates issued by the Notified Body must be included in the submission. The Competent Authorities are responsible for entering the following information in a European medical device databank, EUDAMED ... 

For all products in Classes Ila, lib and III, and AIMDs, a full quality assurance system, audited periodically by a notified body (Annex II of the MDD), which includes examination and certification by the notified body of the design dossier of each product covered. The manufacturer must keep documentation on the quality system and the design dossier of each product plus other documentation. The quality system obligations include post-marketing and vigilance aspects. Compliance with Annex II may be achieved (this is not mandatory but is invariably adopted voluntarily) by compliance with the EN 29000... 

For products in Classes Ila, lib and III, and AIMDs, examination and certification by a notified body of a specimen product (t)q)e examination Aimex III of the MDD) coupled with a varying degree (partially restricted by product class) of product or production quality assurance (MDD Annexes IV, V and VI), which ensures that the manufacturing process produces products that conform to the certified t)q)e and might involve a quality system for manufacture and final inspection (Annex V), or a quahty system for final inspection and testing (Annex VI). 

For devices in Annex 11 and devices for selftesting, all data allowing identification and the analytical parameters and, where applicable, for diagnostic products in Annex 1.3, results of evaluation of performance in accordance with Annex Vlll and certificates of notified bodies. 

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. 

The FDA s access to documentation supporting the QAP and reports must be defined in an SOR All corrective actions are open for inspection under the International Standards Organization (ISO) certification. The ISO notified body is not concerned with regulatory follow-up, as is required by the FDA. 

Table 3.8 gives a list of notified bodies according to Directives 76/117/EEC and 82/130/EEC, referring to article 14 (bodies issuing certificates of conformity or control certificates). 

These notified bodies have introduced a type of certificate without any legal status the component certificate, which is marked by a U following the certificate number. This document acts as a working instrument for a simpler handling of components like conductor bushings, terminal blocks or inspection windows. The notified body issuing such a component certificate herewith declares the conformity with the relevant Harmonized European Norm and the relevant type tests. Other notified bodies accept this document without asking for renewed type tests. In this way, components can be handled in a very efficient... 

Table 3.8 List of notified bodies in the European Union for type testing and certification of electrical equipment for potentially explosive atmospheres...

The notified body verifies the product s compliance with the technical documents and with standards, carries out the type tests according to these standards and issues the EC-type examination certificate. 

The manufacturer applies for assessment of this quality assurance system at a notified body. The quality assurance system shall guarantee the product s compliance with the design according to the EC-type examination certificate and with the requirements given in the directive. 

The notified body affixes the identification number on each product and provides a written certificate of conformity. 

A notified body inspects the item and carries out the relevant tests to ensure the compliance with the relevant requirements given in the directive. The notified body affixes the identification number on each product and provides a certification of conformity. 

Explosion protected electrical equipment for zone 1 (Group II, category 2 G) and the classical firedamp-proof apparatus for coal mines (Group I, category M2) are covered by the B module (EC-type examination) and by the C module (conformity to type) or the E module (product quality assurance). Alternatively, with respect to the B module, the notified body issues an EC-type examination certificate (in German EG-Baumusterpriifbescheinigung), whose marking mainly includes ... 

Accreditation bodies are independent national accreditors who evaluate testing and certification parties according to recognized norms. After a third party is found competent in a member state, such as in Germany, the accreditation body then notifies the European Commission who notifies the other member states by listing them in the Official Journal. These third-party testing and/or certification bodies are then considered EU-accredited third parties or notified bodies. 

Product-specific directives (type C). Product-specific directives apply to regulated products, such as telecom and medical, as well as other products where extreme hazards exist, such as machinery listed in Annex IV of 89/392EEC. Involvement of a EU body may be mandatory, but not in all cases. If the class or type of product is regulated by the directive, then a European body must assess it and issue a Type-Exam Certificate prior to CE marking. Product-specific directives cover machinery, pressure vessels, medical products, telecom devices, toys, and others. It is necessary to refer to the relevant directive to see whether the involvement of a EU-notified body is mandatory for the product or machine in question. lYpe C directives take precedence over types A and B directives and refer to them as needed. 

Voluntary certification. Oftentimes manufacturers have products assessed by a European body (notified or competent) for a mark and certification for marketing purposes and as a defense of due diligence in the event of a challenge. The intervention of notified body certification route provides confirmation of accuracy of the testing and documentation (test reports, etc.). 

Mandatory certification. Most products and machines do not require mandatory certification. But in such cases, as with some high-risk machinery or when harmonized standards do not exist or are not applied in full, a type examination by a notified body is required. After successful testing, a Type-Exam Certificate for machinery or Certificate of Conformity for EMC is issued by the EU Body. The manufacturer then affixes the CE marking and issues a declaration of conformity. 

Notified bodies are listed in the Official Journal of the European Communities Member states should accept test reports and/or certificates of all notified bodies Testing may be subcontracted to other laboratories, under the direct supervision of the body and... 

Accreditation at the European level is a relatively new concept and dates back to the early 1980s. Accreditation means the recognition of the competence of a laboratory, certification, or inspection body by independent accreditors. The accreditation bodies are typically sanctioned by a member state government to perform audits of testing and certification institutions. The audited body must be able to demonstrate that it meets the criteria described in the annexes to the directives to become recognized at the state level and notified to the European Commission and the member states. The bodies that are notified are designated to carry out conformity assessment as set out in the directives. As an assessment technique, accreditation is an... 

Notification is the formal recognition of a testing and/or certification body by the European Commission. After a successful laboratory assessment and recognition by an accreditor, the state government notifies the Commission of the nationally accredited body. The accredited bodies are then listed in the OJEC as Bodies Notified to the Commission and to the Member States, commonly referred to as notified bodies or third parties. 

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