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CE Marking

CE Marking Certification

Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK

CE Marking Certification is done as per Procedure / Scheme No. EVL/CE/PC-A/2020/C-4

CE marking is a Product Certification.

CE marking is a product marking certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA) and various other countries / regions where customers might accept this kind of a certification eg Middle East regions, African countries, India etc. which means that the CE marking is also found on products sold outside the EEA that have been manufactured to such EU / EN standards. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is quite similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.

The CE marking is the manufacturer's declaration that the product meets EU/EN standards for health, safety, and environmental protection for various products.

The mark consists of the CE logo and, if applicable, the identification number of Euro Veritas, UK (www.euroveritas.com) involved in the conformity assessment procedure.

"CE" is indicated as an abbreviation of "Conformité Européenne" (French for "European Conformity"). The CE mark indicates that the product may be sold freely in any part the European Economic Area, and other countries / regions irrespective of its country of origin.

There are two main benefits CE marking brings to businesses and consumers within the EEA and other countries/regions:

   • Companies know that products bearing the CE marking can be traded in the EEA and many other regions / countries without restrictions.

   • Customers and Consumers enjoy the same level of health, safety, and environmental protection throughout the entire EEA and many other regions / countries.

EU Directives: Product Category Wise

Chemicals

   • Chemical substances (REACH)

   • Explosives for civil uses

   • Pyrotechnic articles

Conformity assessment and management systems

   • New Legislative Framework (NLF) and Eco-Management and Audit Scheme (EMAS)

Construction

   • Construction products (CPD/CPR)

Consumers and workers protection

   • Cosmetics products

   • General product safety

   • Personal protective equipment (PPE)

   • Toys safety

Energy efficiency

   • Ecodesign and energy labelling

Electric and electronic engineering

   • Electromagnetic compatibility (EMC)

   • Equipment for explosive atmospheres (ATEX)

   • Low Voltage (LVD)

   • Radio Equipment (RED)

   • Restriction of the use of certain hazardous substances (RoHS)

Healthcare engineering

   • Active implantable medical devices

   • In vitro diagnostic medical devices

   • Medical devices (MDD)

Measuring technology

   • Measuring instruments (MID)

   • Non-automatic weighing instruments (NAWI)

Mechanical engineering and means of transport

   • Cableway installations designed to carry persons

   • Equipment for explosive atmospheres (ATEX)

   • Gas appliances (GAR)

   • Inspection of pesticide application equipment

   • Lifts

   • Machinery (MD)

   • Pressure equipment (PED)

   • Rail system: interoperability

   • Recreational craft and personal watercraft

   • Simple Pressure Vessels (SPVD)

Services

   • Community postal services

Sustainability

   • Packaging and packaging waste

How do you affix the CE marking?

The CE marking logo should be visible, legible and indelible.

The CE marking must consist of the initials "CE", both letters should have the same vertical dimension and be no smaller than 5mm (unless specified differently in the relevant product requirements).

If you wish to reduce or enlarge the CE marking on your product, you should respect the proportions of the two letters. As long as the initials remain visible, the CE marking can take different forms (for example colour, solid or hollow).

If the CE marking cannot be affixed to the product itself, you can affix it to the packaging if there is any, or to any accompanying documents. If your product is subject to several EU directives/regulations which require a CE marking to be affixed, the accompanying documents must indicate that your product conforms to all applicable EU directives/regulations.

When is CE marking mandatory?

CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.

This is generally mentioned in the specific EU Directive specifically for the product.

Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.

How to obtain CE marking Certification? Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK

As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You need a certificate from Euro Veritas, UK (www.euroveritas.com)

to affix the CE marking to your product, however, before doing so, you must:

   • Identify the correct EU Directive and comply to it

   • ensure conformity with all relevant EU-wide requirements

   • Identify the correct Harmonised Standards and other standards. (It is not mandatory to have Harmonised Standard for each type of item / product / product family).

   • Harmonised Standards are respective of the EU / EN Directive.

   • determine whether you can test your product by yourself or if you have to involve a 3rd party Lab

   • put together a technical construction file (TCF) documenting conformity: find out about technical documentation

   • draft and sign an EU declaration of conformity (This is as per the EU / EN Directive)

Do you need an independent assessment?

You need to check if your product has to be tested by a 3rd Party approved Lab. You can find this information in the relevant legislation / Directive applicable to your product: check the rules by product category.

This step is not obligatory for all products.

You need to get the item / product tested by the 3rd Party Lab, and send out the reports to Euro Veritas, UK (www.euroveritas.com). Based on such test reports and TCF documentation, Euro Veritas, UK (www.euroveritas.com) shall provide a Certificate of Conformity to the company / Organization.

The CE mark and the identification number of Euro Veritas, UK Accreditation can be affixed separately, as long as they appear clearly linked to each other.

If your product doesn't need to be verified by an independent 3rd party Lab, then the company must make provisions to test the product / item in-house- to check that it complies with the technical requirements. This includes estimating and documenting the possible risks when using your product.

Generally Euro Veritas, UK (www.euroveritas.com) auditors does witnessing of such testing / inspection of the tests being conducted by the company / organization.

You need to get the item / product tested independently and in-house, and send out the reports to Euro Veritas, UK (www.euroveritas.com). Based on such test reports and TCF documentation, Euro Veritas, UK (www.euroveritas.com) shall provide a Certificate of Conformity to the company / Organization.

MEETING EU CE MARK REQUIREMENTS AND CONFORMING TO DIRECTIVES

Affixing a CE Mark to a product is considered a means to certify for authorities that the product meets all appropriate EU/EN requirements.

There is an EU requirement that products not in conformity with the provisions of the directives are not allowed to circulate in the territories of the member states; appropriate action might be taken to remove these products from sale and use within the specific state. One example is the recent import of toys from China to the UK which, when examined, were found to contain a high level of poisonous toxins that endanger life.

The importer and/or manufacturer must take steps to comply with safety provisions, produce the appropriate records, and decide on the necessary procedures to maintain production in conformity with directives. The CE Mark must be affixed to demonstrate conformity with the provisions of the directives.

Specific directives have comprehensive safety objectives, but they leave the manufacturer to make decisions on how these may be achieved.

Where more than one CE Mark directive pertains to a product and a transitional period allows the manufacturer a choice of which to apply, the marking indicates conformity only with those directives applied by the manufacturer. In this case the directives that have been applied must be identified in the documents or notices accompanying the product. Where the manufacturer does not list those directives that have been applied, the authorities will assume that a declaration of conformity is available for all applicable directives.

   • The company / Organization while framing the EU Declaration of Conformity or Declaration of Performance must write the applicable EU Directives and Harmonised Standards.

   • The CE Marking Compliance Certificate from Euro Veritas, UK (www.euroveritas.com) must al mention the EU Directive and respective Harmonised and / or other applicable complying standards.

General principles of the CE marking and Certification from Euro Veritas, UK (www.euroveritas.com):

   1. The CE Marking Certification is a Product certification and does not apply to the company / system / organization who is manufacturing it.

   2. The CE marking shall be affixed only by the manufacturer or his authorised representative.

   3. The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonization legislation (EU Directive), and shall not be affixed to any other product being manufactured by the company.

   4. The Company / Organization / Manufacturer / Authorised Representative must first draw up an EU Declaration of Conformity / Declaration of Performance as per the specific EU Directive. This document shall mention all technical details about the product.

   5. By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product (safety, health, environmental, and quality performance) with all applicable requirements set out in the relevant Community harmonization legislation (EU Directive) providing for its affixing.

   6. The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonization legislation(EU Directive) providing for its affixing.

   7. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.

   8. Accepting countries shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Accepting countries shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.

WHAT IS THE USE OF CE CERTIFICATE?

   1. A manufacturer / company who affixes CE marking to his products, declares that the products are in conformity with all necessary requirements (regulations- EU Directives and standards) and can be sold in the particular region. CE Certificate secures two great advantages for the business world and consumers. The business world acknowledges that products bearing CE marking can be sold in the European Economic Area and other relevant countries / regions eg Middle East and India and Africa- without facing any barriers, and consumers feel assured that products they purchase meet all essential health, safety and environmental requirements.

   2. It is the manufacturer’s responsibility to carry out conformity assessment of products, to prepare technical files, to acquire CE marking where necessary, to draw up EU Declaration of Conformity, and to affix CE marking to the products, after audit / witness of tests / factory production audit / inspection by auditors from Euro Veritas, UK (www.euroveritas.com).

WHAT INFORMATION SHOULD BE INCLUDED IN THE EU DECLARATION OF CONFORMITY?

The EU Declaration of Conformity should contain the following information related to the product, manufacturer or representative, strictly as per the requirements as have been defined and listed within EU Directives (Community harmonization legislation) and where applicable, harmonised standards:

   • Unique identification of product- Product Name, Model Name, Product / Model No.

   • Name and address of manufacturer and / or authorised representative,

   • Statement of sole responsibility of the manufacturer of this declaration,

   • Identification of product allowing traceability, clear product photograph where appropriate,

   • Relevant European Community directive / EU Directive,

   • References to the relevant harmonised standards and/or specifications,

   • Where applicable, the name and details of 3rd Party Test Lab, description of the module and CE certificate information,

   • Additional information, signature, name and function of designated signatory, and place and date of issue.

Though the information mentioned inside the EU Declaration of Conformity / Declaration of Performance depends specifically on the requirements as have been mentioned in the specific Product EU Directive (Community harmonization legislation).

CE CERTIFICATE AND CONFORMITY ASSESSMENT MODULES- AS PER Euro Veritas, UK (WWW.EUROVERITAS.COM) ACCREDITATED FROM BAR-UK- AS PER PROCEDURE / SCHEME NO. EVL/CE/PC-A/2020/C-4

Conformity assessment modules cover both the design and production phases. While some cover only one phase, others can do both. Conformity assessment generally modules consist of 8 main categories: (Though the applicant is advised to refer to the product specific EU Directive)

   • Module A, A1, A2 – Internal production control

   • Module B – EU-type examination

   • Module C, C1, C2 – Conformity to EU-type based on internal production control

   • Module D, D1 – Conformity to EU-type based on quality assurance of the production process

   • Module E, E1 – Conformity to EU-type based on product quality assurance

   • Module F, F1 – Conformity to EU-type based on product verification

   • Module G – Conformity based on unit verification

   • Module H, H1 – Conformity based on full quality assurance

Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK

CE Marking Certification is done as per Procedure / Scheme No. EVL/CE/PC-A/2020/C-4.

Please contact us at Euro Veritas, UK (www.euroveritas.com) for details on:

   • EU Declaration of Conformity

   • Witness Audits

   • CE Marking and Certification

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