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CE Mark Decision 768/2008/EC Compliance December 2012 What is CE Marking? Who should consider CE Marking? How to CE Mark?
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Introduction to the requirements of CE Mark Decision 768/2008/EC CE marking or ‘Conformitee Europeenne’ is not just a safety standard, although product safety is the major concern. It is better to think of CE marking as demonstrating that a product is suitable for its intended use. CE marking is a required common compliance marking that is accepted by all EU member states, allowing the free movement of goods across the European Union. Affixing the CE mark is a declaration by the producer that the product has been designed, tested and manufactured to meet the essential requirements of all applicable CE directives. Not only does it declare that a product is safe, but it is also suitable for use in the function for which it was designed and that it will not have adverse effects on its surroundings. CE marking also requires that products are designed to be environmentally friendly, both in their operation and at end of life.
The New Approach directives are harmonised under council decision 768/2008/EC which defines a common framework for the marking of products, summarised in the following four steps: 1. Conformity Assessment The process, considerations and identification of documents required to demonstrate conformity. It assesses the intended use of the product.
CE marking has two practical benefits:
It harmonises the compliance standards of all EU member states. For example, the standard that is acceptable in the UK is also acceptable in Spain, Germany, Italy and so on.
It harmonises the image used for marking compliant products across all EU member states. This makes it easy to identify that a product is suitable for its intended use – just look for the CE mark logo.
How does CE Marking work? CE mark has, at its centre, a fundamental set of essential requirements which define obligatory product characteristics. These essential requirements depend on the function of the product and are separated into 24 New Approach directives, all under the umbrella of the CE mark.
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2. Construction of Technical File Rationale and supporting evidence to prove a product is compliant; content is dependent on the findings of the conformity assessment. 3. Declaration of Conformity (the DoC) A standardised document provided by the manufacturer declaring a product is CE compliant. 4. CE Mark Fixing the CE mark to a product. There are specific requirements of how the CE mark should appear in relation to its size and visibility. Products are assessed on a case-by-case basis, with their functions and physical characteristics investigated. The assessment process begins at the design phase and continues until the product goes into manufacture, when any modifications to its design or changes to the manufacturing process should be recorded. If the changes could affect the conformity of a product, then a reassessment is necessary.
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The below diagram depicts how the process of CE Marking is structured; showing the relationship between council decision 768/2008/EC and New Approach directives for CE marked products:
CE Mark Directives Here is a list of all the New Approach Directives currently enforced across the EU. All products falling into the scope of one or more of these directives must carry the CE mark.
use in potentially explosive atmospheres 7.
Explosives for civil uses
8.
Hot water bottles
9.
In vitro diagnostic medical devices
10. Lifts 11. Low Voltage Devices (LVD)
1.
Active implantable medical devices
2.
Appliances burning gaseous fuels
3.
Cableway installations designed to carry persons
4.
Eco-design of energy related products
5.
Electromagnetic compatibility (EMC)
6.
Equipment and protective systems intended for
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12. Machinery 13. Measuring instruments 14. Medical devices 15. Noise emission in the environment 16. Non-automatic weighting instruments
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17. Personal protective equipment 18. Pressure equipment 19. Pyrotechnics 20. Radio and telecommunications terminal equipment (R&TTE) 21. Recreational craft 22. Restriction of Hazardous Substances (RoHS) 23. Safety of Toys 24. Simple pressure vessels
Manufacturer: This is the person responsible for the design and manufacture process, as a manufacturer applying the CE mark implies you take responsibility for the compliance of the product. The manufacturer must compile a Technical File and EU Declaration of Conformity (these are documents to confirm the compliance of a product, there is more detail to follow).
Who should consider CE Marking?
Importer: Importing a product from outside the EU and placing it on the market implies you take responsibility for the compliance of the product.
When introducing a product on the EU market which requires a CE mark, EU legislation defines the person placing the product on the market as one of the following:
The importer cannot compile a Technical File or issue a Declaration of Conformity but must ensure both are available if necessary.
1. Manufacturer Shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark. 2. Importer Shall mean any natural or legal person established within the Community who places a product from a third country on the Community market. 3. Distributor Shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market. 4. Authorised Representative Shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks.
Identifying who is liable for products which carry a CE mark relies on these definitions. Any investigation or prosecution by an EU member state or private pursuit for damages would look at supply chain of a non-compliant product, identify the above and assess their responsibilities under CE marking. This is a summary of the responsibilities of each producer defined above:
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The importer is equally liable as the manufacturer for non-compliance if adequate documentation is not available.
Distributor: Distributing products within the EU carries the least risk. Providing products are sourced within the EU and are not modified, CE marked products can be distributed. Obtaining a copy of the EU Declaration of Conformity is advisable. Recent recasts to CE marking directives have increased the obligations of a distributor, under RoHS for example, the distributor may have to hold the technical documentation.
Authorised Representative: Where a manufacturer has identified an authorised representative by means of contractual agreement, the representative assumes responsibility for the compliance of the product. The exact extent of the representative’s responsibility will be documented in the terms and conditions of the contract. For example: A branded TV company (Sony, Panasonic etc) manufactures products in the Far East where they are available for wholesale purchase.
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A distribution company purchases TVs in the Far East for distribution in the EU, under the producer definition it would be the distribution company who would be considered an importer. In addition, if the TV manufacturer has an EU authorised representative, it is the representative who adopts the manufacturer obligations. .
How to CE Mark? Applying the CE mark is essentially a risk assessment. The liability for CE marked products lies with the manufacturer and it is up to them to be satisfied that their product is compliant. If it shown to be non-compliant the manufacturer can be prosecuted by member state enforcement agencies and sued for damages. Member state enforcement usually carries a fine per product in the range of €5000; although there is no limit to the amount of damages that can be awarded. The Process 1. Conformity Assessment
Taking a low risk product as an example, the technical file can be summarised as follows: Product description: A general description of the product, preferably including a picture. Drawings: Design and manufacture drawings including all subassemblies, components and circuits. Functional Description: A description of the design drawings relating to component and subassembly function. AND A description of the manufacture process should be included. List of EU Directives Applied: List of directives and rationale that describes why they were applied. Design Calculations Design calculations to support compliance and suitability of design. Test Reports Test reports of prototypes and finished products.
2. Construction of Technical File 3. Declaration of Conformity (the DoC) 4. CE Mark Working from the summary above, Step 1 of CE marking is the conformity assessment procedure. This shows a product requires CE marking and it must be compliant. Step 2, the construction of a technical file, is the process defined by the EU that manufacturer’s must use to demonstrate conformity. Steps 1 and 2 are interlinked and the contents of a technical file depend on the conformity assessment of the product. IMPORTANT TO NOTE! Generally higher risk products have a more stringent assessment process and in turn require more information in to be gathered. In some instances, such in the case of certain medical products for example, the product must be assessed by a notified body.
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Once the product has been assessed, a Declaration of Conformity must be drawn up. It acts as a legal statement from the manufacturer summarising the conformity of their product. It is a standard document and follows this general format:
EC DECLARATION OF CONFORMITY 1. No … (unique identification of the product): 2. Name and address of the manufacturer or his authorised representative: 3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer): 4. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate): 5. The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: 6. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared 7. Where applicable, the notified body ... (name, number) … performed … (description of intervention) … and issued the certificate: … 8. Additional information: Signed for and on behalf of: ………………………………… (place and date of issue): (name, function): (signature):
The named person on the declaration will be personally responsible for the compliance of the product. In cases of corporate liability, this person could be prosecuted.
Next steps
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Now that you have a general understanding of the CE Mark directive, the next step is to work out which of the 24 separate directives under the CE mark umbrella apply to your product, and then from there which specific standards need to be applied. Use this great tool on the European Commission to access all relevant documentation: -
European Commission Reference Website Tool
Please note: The information contained in this guide is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavour to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation. ©2012 Premier Farnell plc. Permission is granted for reproduction in whole or in part providing Premier Farnell plc is credited. December 2012
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