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CE Mark

Conformitè Europëenne

CE (Conformitè Europëenne)

The Conformitè Europëenne (CE) Mark is defined as the European Union's (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer's declaration that products comply with the EU's New Approach Directives. The CE mark is a Product Certification and it signals that the product meets the requirements of relevant European directives. It is mandatory for a wide product range sold within or exported to the European Country or market. Compliance of these standard or directive is mandatory. Other definition: The CE mark is a Product Certification and it signals that the product meets the requirements of relevant European directives. It is mandatory for a wide product range sold within or exported to the European Country or market. ... Compliance of these standard or directive is mandatory.

Requirements For CE Mark

Six steps to get CE marking

  • Find the CE directive(s) that apply to your product
  • Know the essential requirements for your product
  • Determine if you need third-party certification
  • Assess product conformity
  • Create and maintain technical documentation
  • Declaration of Conformity & affixing the CE Mark

Benefits of CE Certification:

The manufacturer or the authorized representative can only affix CE marking. The CE marking cannot be affixed on the product that doesn’t fall under the EU’s directives and regulations. The CE marking shall be the only marking that attests to the product’s conformity with the relevant Community harmonization legislation’s applicable requirements providing for its affixing. The appearance of the CE marking should not mislead concerned parties. The marking should be done as per the prerequisites mentioned in the EU’s legislation. Member states are responsible for maintaining the integrity of the CE certification/marking. To do so, they need to deploy relevant penal provisions to counteract the cases of infringement. Those penalties will be imposed accordingly as per the felony’s intensity and implement the deterrent to avert unethical use of the CE logo. The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EEA). The great benefit for manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and 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.

What is the CE marking process?

CE marking is the final stage of the conformity assessment process as specified in the relevant Directive for the product. The conformity assessment process (sometimes referred to as the CE marking process) is concerned with: assessing the risks presented by a product throughout its lifecycle meeting safety objectives by design and construction taking account of the current best practice to ensure the safety for that product, known as the state of the art in some cases the supply Directive will require the use of third parties who have been notified by an EU member state to the EU Commission (usually referred to as "Notified Bodies") to verify compliance collecting and retaining information about the design, testing and construction process and the means by which the product complies with the essential requirements of all relevant product safety Directives in a technical file which in most cases must be kept for at least 10 years after the last product of the product line has been produced declaring the product's conformity with all relevant product safety law by means of a document (the Declaration of Conformity), which in most cases must accompany the product down the supply chain to the end user and the preparation and provision of comprehensive product User Instructions, in the language of the end user. CE Directives & categories your product falls into:-

1 Radio equipment directive (RED) 2014 53 EU
2 Low voltage directive (LVD) 2014 35 EU
3 Electromagnetic compatibility directive (EMC) 2014 30 EU
4 Medical devices directive (MDD) 2007 47 EC
5 Directive on active implantable devices (AIMD) 90 385 EEC
6 In vitro diagnostic medical devices directive (INVMD) 98 79 EC
7 Machine directive (MD) 2006 42 EC
8 Directive on the restriction of the use of certain hazardous substances (RoHS) 2006 42 EC
9 Waste electrical and electronic equipment directive (WEEE) 2012 19 EU
10 Batteries directive (BATTERY) 2006 66 EC
11 Equipment directive for potentially explosive atmospheres (ATEX) 2014 34 EU
12 EcoDesign requirements directive for energy-related products (ECODESIGN) 2009 125 EU
13 Directive on the labeling of energy-related products (LERP) 2010 30 EU
14 Directive on packaging and packaging waste (WASTE) 2015 720
15 General product safety directive (GPSD) 2001 425 EU
16 Personal protective equipment directive (PPE) 2016 425 EU
17 Toy safety directive (TOY) 2009 48 EC
18 Directive on explosives for civil use (ECU) 2014 25 EU
19 Pyrotechnic substances directive (PTA) 2013 29 EU
20 Measuring instruments directive (MID) 2014 32 EU
21 Non-automatic weighing instruments directive (NAWI) 2014 31 EU
22 Ropeway installation directive (CWI) 2016 424
23 Safety components for lifts and elevators (LIFTS) 2014 33 EU
24 Directive for simple pressure vessels (SPVD) 2014 29 EU


Determining YOUR PATH TO MARKET IN EUROPE

The European Union has a similar product classification system as the U.S.:

  • Class I
  • Class II a
  • Class II b
  • Class III
In all cases for medical devices to be sold in the European Union, technical documentation is a required step in the process of obtaining CE Marking. All medical device classes in the EU require working with a Notified Body, except for those which are Class I and can be self-certified.

CE Mark for Medical devices & face masks:

Before a medical device can be launched in the European Economic Area (EEA), it must receive a CE mark. The CE mark confirms that the medical device meets certain "essential requirements" of the European General Medical Devices Directive (i.e. that it is fit and safe for the intended purpose). It also shows that the medical device can be freely marketed anywhere in the EEA without further control. CE marking is mandatory, even if the medical device was manufactured outside the EEA. It is the manufacturer's sole responsibility to obtain and place the CE mark on the product. If the product is imported from outside the EEA, then this responsibility falls to the importer within the community. Placed on many categories of products, CE Marking is mandatory for machinery, electrical and electronic equipment, medical devices, hazardous location equipment, and other products. So if you are looking to sell an electronics product in the EU, you will need to apply a CE mark.

CE for Electrical devices & Electronic Equipment

The CE mark, or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985 CE stands for Conformité Européenne (French), which means European conformity CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product’s compliance with relevant requirements With a CE mark, your product can be sold in the EU and in Iceland, Liechtenstein, and Norway There are six steps to CE marking

  1. Identify the relevant directives and standards,
  2. Verify the product’s specific requirements,
  3. Identify whether an independent conformity assessment (Notified Body) is necessary,
  4. Test product,
  5. Create technical documentation,
  6. Add CE mark to the product

CE marking is not evidence of compliance – your technical documentation/technical file is The manufacturer or authorized representative must keep technical documentation for a number of years (the number is dependent on the product type) after the last product has been placed on the market Each EU country is responsible to enforce CE marking, by banning products and levying fines for non-compliance Unsafe products are shared in the EU a rapid alert system on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers There is a very similar logo where the CE stands for Chinese Export or China Export – this has nothing to do with European conformity Pre-testing early in the product development process can reduce cost and time to market

Conclusion

CE marking allows free movement and sale of goods throughout the European Economic Area. For you to grow your business and distribute your products in the European market, CE-marking is mandatory for many products. It is a self-declaration process that your product complies with the directives which may include EMC & wireless radio testing. Consult with E-certifications experts if you want to avail CE certification or explore more detail on the benefits of CE certification.