October 21, 2015

CE Marking

What is CE Marking

  • 1.CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.
  • 1.CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
  • 1.CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.

General principles of the CE marking

  • The CE marking shall be affixed only by the manufacturer or his authorised representative
  • The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.
  • By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
  • The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.
  • 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.
  • Member States 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. Member States 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.

If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the members states of the European Economic Area (EEA), then you must apply CE Marking to your product against the essential requirements of all these applicable directives.

The New Approach Directives will provide a range of compliance routes for your product and show you, usually in a modular format, the available routes to compliance.

You must then decide which is the best fit for your company set up and follow the routes detailed in the Directive.

In many cases the compliance route will require you to use a Notified Body to assist with your certification.

The essential requirements of the New Approach Directives differ from directive to directive and product to product.

We offer CE marking services for all the New Approach directives under the scope of CE marking as follows:

  • Medical Devices (MDD) – 93/42/EEC
  • Pressure Equipment (PED) – 97/23/EC
  • Transportable Pressure Equipment Directive – 99/36/EC
  • Simple Pressure Vessels – 87/404/EEC
  • Construction Products (CPD) – 89/106/EEC
  • Low Voltage Equipment (LVD) – 2006/95/EC
  • Electromagnetic Compatibility (EMC) – 89/336/EEC
  • Machinery – 98/37/EC
  • Lifts – 95/16/EC
  • Personal Protective Equipment (PPE) – 89/686/EEC
  • Toys – 88/378/EEC

Benefits of CE Marking

The CE Marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 18 countries of the European Economic Area (EEA).

There is only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. Various conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.

The CE Marking is required only for the following types of products:

  • Toys
  • Machinery
  • Electrical equipment
  • Personal protective equipment
  • Pressure equipment
  • Medical devices
  • Active implantable medical devices
  • In vitro diagnostics
  • Radio and Telecommunications terminal equipment
  • Simple pressure vessels
  • Gas appliances
  • Lifts
  • Recreational craft
  • Equipment and protective systems for use in explosive atmospheres
  • Non-automatic weighing instruments
  • Cableways
  • Construction products
  • Explosives for civil use
  • New hot water boilers
The CE Marking is NOT required for the following types of products:
  • Chemicals
  • Pharmaceuticals
  • Cosmetics
  • Foodstuffs
Requirements for Affixing of the CE Marking

The CE Marking must be affixed to the product, to its data plate or, where this is not possible or not warranted due to the nature of the product, to its packaging, if any, and to the accompanying documents by the manufacturer, the authorized representative in the European Community or, in exceptional cases, by those responsible for placing the product on the market.

How to achieve CE Certificate ?

Seven Steps of CE-Marking

Step1: The first steps towards CE-marking your product is determinig your product’s application and establishing which directives apply to it.

Step2: Applying standards
The process is getting your product to meet the essential requirements laid down in the directives.

Step3: Make sure your product is safe and be able to prove it. So carry out a risk assessment or analysis and show how you meet the requirements laid down in the directives.

Step4: Technical document
Drawing up technical documentation or a technical file, intended to provide information on the design, manufacture and operation of your product.

Step5: User Manual
The fifth step is to apply the product with instructions for the end user, including legal obligations, instructions for use and clear documentations, stating the purpose of the product and the risks related to its use under normal circumstances.

Step6: Declaration of conformity
The sixth step is the declaration on conformity, one of the final steps in the CE marking procedure. The declaration of conformity must contain all relevant product information, including which EU directive(s) the product now complies with.

Step7: Affixing the CE mark
The seventh step is to affixing the CE-mark, which means you declare to all parties Involved that your product conforms to all applicable provisions.

How can I obtain the CE marking for my products?

  • Determine the product family to be offered and determine which European Norm is applicable to that product.
  • Identify the Initial Type Testing requirements and carry them out internally
  • Decide on the system of Attestation of Conformity applicable to the product.
  • Prepare and launch necessary FPCs.
  • If the system of attestation requires it, choose a Notified Body and undertake Initial Type Testing or go ahead with self declaration.
  • Get approval of your FPCs by the Notified Body and arrange surveillance if necessary.
  • Develop and maintain a technical file containing all relevant technical and test data.
  • Prepare declarations of conformities
  • Produce the CE marking label and accompanying information.

What we offer in the field of CE certification

As one of the largest product certification and ISO management system certification consulting companies across the world with clients in more than 40 countries, our knowledge and experience of the standards is unsurpassed. We understand how to fully exploit the benefits of your product certification to ensure you unlock the true potential in your organization.

We provide unmatched expertise and technical competence to ensure that CEcertification project adds value to your organization.

We offer our global knowledge moulded locally to bring in the best results for our clients and partner their journey of standardization, compliance, growth, success and continual improvements.

Contact us now, to get your organization CE certified in the most effective and efficient manner while realizing the true benefits of the certification using our specialized CE Compliance methodology that is less time consuming, fast, easy to understand and implement, result oriented, time bound and cost effective. Get CE certified now with us….