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Eurofins >> Certifications & International Approvals >> Notified Body

Notified Body

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Index:

 

CE Mark - Introduction

The CE mark is a prerequisite for a number of products for being marketed in the European Union. The EU Commission says:

By affixing the CE marking on a product, the manufacturer declares on his/her sole responsibility that the product is in conformity with the essential requirements of the directives that apply to it and that the relevant conformity assessment procedures have been fulfilled. Thus products bearing the CE marking benefit from free circulation in the European Market.

The required declaration of product properties are laid down in European norms issued by CEN.

Please note also another important remark on the website of the European Commission:

  • Not all products must have CE marking. It is compulsory only for most of the products covered by the New Approach Directives. It is forbidden to affix CE marking to other products.
  • Please note that a CE marking does not indicate that a product have been approved as safe by the EU or by another authority. It does not indicate the origin of a product either.

You can find information on CE marking tailored for manufacturers, importers, distributors and consumers.

CE mark is administered in a very different manner when compared between different product groups. This regards both how challenging the specifications are, and how tight is the net of monitoring and control by independent certification and inspection agencies, the so-called notified bodies. Any notified body has to be approved by a EU member state. The approval is valid only for a certain, well-defined area.

Notified bodies for CE marking

At present, several laboratories within Eurofins Group are operating such notified bodies for CE marking of toys, medical devices, construction products, personal protective devices, aspects of machinery safety, lifts and more.

For more details, please see our notifications at NANDO database:

Please see also a complete list of notified bodies, and for what areas they are approved, at NANDO database.

New Approach

The declaration of conformity and the CE marking are the two instruments which allow the free circulation of products within Europe. In fact the need of removal of technical barriers which obstruct the free circulation of products is already established in the " Rome's Treaty" of 1957. Since 1985 many directives specifying properties of products followed the "General Approach", which, besides other issues:  

  • assert the principle according to which the needs of safety, health, and environmental prevention has to be harmonized in Europe;
  • affirm that a product which is legally commercialized in a member state can be commercialized also in other members's states;
  • fix the essential requirements of health, safety and environmental prevention;
  • identify, through harmonized standards, how to satisfy some or all the requirements requested by directive;
  • specify that the harmonized standards have to be transponded in national standards.
  • assign to manufacturer the responsibility to issue the CE Declaration of conformity and to affix the CE marking;
  • introduce the principle of presumption of conformity for the products which are CE marked and which are accompanied by Conformity's Declaration.

From 1993 the directives, written according to the so-called "New Approach", have introduced the modular scheme, which identifies in general principles and procedures for the conformity's evaluation and for the CE markings apposition. The conformity's evaluation can be attested though one or more certifications, according to the referring directive. With the exception of particular modules, all certifications require the involvement of a Notified Body which, according to the provided process, can:

  • verify and approve the conformity to requirements through exams and/or tests on product;
  • approve and supervise the system of warranty of the quality of the manufacturer.

Machinery

  • 2006/42/EC Machinery Directive
  • Technical control according to DLGS 81/08
  • Technical verifications: manufacturer
  • Technical verifications: user

Pressure equipment

  • Pressure equipment DirectivePED (97/23/CE Directive)
  • Transportable pressure equipment Directive T-PED (99/36/CE Directive)
  • Technical control according to DLGS 81/08
  • Technical verifications: manufacturer
  • Technical verifications: user

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Lifts

  • Lift directive, LD (95/16/CE Directive)

EMC, ATEX, RED

Management systems

  • Third part Audit according to standard, directive, law or commercial specifications

PPE, NED, liability products

  • Personal Protective equipment Directive PPE (89/686/CEE Directive)
  • Noise Emission of machineries working outdoors Directive NED (2000/14/CE Directive)
  • Liability products
  • Verification of the conformity of the products to the essential requirement of the applicable European directives

Construction products

(see also the industry overview)

  • Construction Products Regulation (EU 2011/305), EN 16516

  • Road traffic noise reducing devices (noise barrier)
    EN 1 4388

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  • Windows and external pedestrian doorsets
    EN 14351-1

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  • Curtain walling EN 13830

  • Industrial, commercial and garage doors and gates
    EN 13241-1

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  • Handles and knobs
    EN 1906

  • External blinds and shutters
    EN 1932

  • Fixed, vertical road traffic signs, EN 12899-1

 

Medical Equipment

Toys

Directives / Regulations

Our Certification Bodies are notified as NB under the following Directives/Regulations: