Notified Body
Index:
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:
- Eurofins Product Testing Italy S.r.l (Italy)- NB No. 0477
- Eurofins Product Testing Services Ltd (UK)-NB No. 0355
- Eurofins York EMC Service Ltd (UK) - NB No. 2636
- Eurofins Hursley EMC Services Limited (UK)- NB No. 2635
- Eurofins Product Testing A/S (Denmark)- NB No. 2657
- Eurofins Product Service GmbH (Germany)- NB No. 0681
- Eurofins Electrosuisse Product Testing AG (Switzerland)- NB No. 1258
- Eurofins MET Laboratories, Inc. (US)- NB No. 0980
Please see also a complete list of notified bodies, and for what areas they are approved, at NANDO database.
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
Pressure equipment
Lifts
EMC, ATEX, RED
Management systems
PPE, NED, liability products
|
(see also the industry overview)
|
Our Certification Bodies are notified as NB under the following Directives/Regulations:
- ATEX Directive 2014/34/EU
- Construction Products Regulation (EU) No 305/2011
- EMC Directive 2014/30/EU
- Lifts and safety components for lifts Directive 2014/33/EU
- Machinery Directive 2006/42/EC
- Medical Device Directive 93/42/EEC
- Outdoor Noise Directive 2000/14/EC
- Personal protective equipment Directive 89/686/EEC - Personal protective equipment Regulation (EU) 2016/425
- Pressure equipment Directive 2014/68/EU
- Radio Equipment Directive (RED) 2014/53/EU
- Toy safety Directive 2009/48/EC
