The Top 5 Mistakes in Making a Declaration of Conformity for CE Marking

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2 Contents Introduction... 2 The top 5 mistakes in making a Declaration of Conformity Not making a Declaration of Conformity Making a Declaration that doesn t cover all of the applicable EU Directives Not having someone of suitable authority sign the Declaration Not including enough data in the Declaration to enable good traceability Not including in the name and identification number of the Notified Body that performed their conformity assessment... 6 How Intertek can help... 6 About Intertek... 6 Introduction A Declaration of Conformity is required in the EU, to indicate the mandatory compliance of certain products types with the requirements governing them in the region. Once a manufacturer has made a Declaration of Conformity, CE Marking can be applied to the product. Decision No 768/2008/EC on a common framework for the marketing of products says: Article 5 legislation shall provide that a single declaration shall be drawn up in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates, and giving the publication references of the acts concerned. By ensuring all products from across the region meet common criteria, consumers can expect a degree of common basic performance from all products and judge products on a like for like basis. In conjunction with CE Marking, it enables free movement of goods across the region and means all manufacturers selling to EU citizens make a commitment to a minimum set of performance criteria. The requirements for a Declaration, i.e. what should be included in it, are laid out in the Annex s of the CE Marking Directives (listed below) and a Declaration can cover a series of products - models within a product family can be grouped together under one Declaration. But mistakes in Declarations are common. This short guide outlines the top five mistakes that manufacturers make in their Declaration of Conformity, which in effect makes their product non-compliant. 2

3 The top 5 mistakes in making a Declaration of Conformity 1. Not making a Declaration of Conformity Manufacturers of products entering the EU market for the first time sometimes don t realise that they have to make a Declaration of Conformity and apply CE Marking to their product. They haven t had to do so in their local market so they are unfamiliar with it. Now perhaps they are selling over the internet and some of their customers are in the EU, so they need CE Marking. has an excellent summary list of the CE Marking product categories: Active implantable medical devices appliances burning gaseous fuels cableway installations designed to carry persons eco-design of energy related products electromagnetic compatibility equipment and protective systems intended for use in potentially explosive atmospheres explosives for civil uses hot-water boilers household refrigerators and freezers in vitro diagnostic medical devices lifts low voltage machinery measuring instruments medical devices noise emission in the environment non-automatic weighing instruments personal protective equipment pressure equipment pyrotechnics radio and telecommunications terminal equipment recreational craft safety of toys simple pressure vessels 3

4 2. Making a Declaration that doesn t cover all of the applicable EU Directives By making a, a manufacturer declares compliance with all applicable Directives that govern their product. This can be many more than some organisations are aware of. The Blue Guide on the implementation of EU product rules, published by the EU Commission, identifies all of the Directives that fall under the CE Marking requirements: The restriction of the use of certain hazardous substances (RoHS) in electrical and electronic equipment (Directive 2011/65/EU) Appliances burning gaseous fuels (Directive 2009/142/EC) Ecodesign requirements for energy-related products (Directive 2009/125/EC) Simple pressure vessels (Directive 2009/105/EC) Toys safety (Directive 2009/48/EC) Electrical equipment designed for use within certain voltage limits (Directive 2006/95/EC) Machinery (Directive 2006/42/EC) Electromagnetic compatibility (Directive 2004/108/EC) Measuring instruments (Directive 2004/22/EC) Non-automatic weighing instruments (Directive 2009/23/EC) Cableway installations designed to carry persons (Directive 2000/9/EC) Radio equipment and telecommunications terminal equipment (Directive 1999/5/EC) Active implantable medical devices (Directive 90/385/EEC) Medical devices (Directive 93/42/EEC) In vitro diagnostic medical devices (Directive 98/79/EC) Pressure equipment (Directive 97/23/EC) Transportable Pressure equipment (Directive 2010/35/EU) Aerosol Dispensers (Directive 75/324/EEC as amended) Lifts (Directive 95/16/EC) Recreational craft (Directive 94/25/EC) Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 94/9/EC) Explosives for civil uses (Directive 93/15/EEC) Pyrotechnics (Directive 2013/29/EU) Efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (Council Directive 92/42/EEC) Personal protective equipment (Directive 89/686/EEC) Marine equipment (Directive 96/98/EC) 4

5 Noise emission in the environment by equipment for use outdoors (Directive 2000/14/EC) Emissions from non-road mobile machinery (Directive 97/68/EC as amended) Energy labelling (Directive 2010/30/EU) Obviously not all of these apply to all products, but Directives such as the Ecodesign requirements for energy-related products (Directive 2009/125/EC) and the Restriction of the use of certain Hazardous Substances - RoHS (Directive 2011/65/EU) do apply to most electrical products and can get easily overlooked when Safety and EMC are often prioritised. 3. Not having someone of suitable authority sign the Declaration By making a Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product. They express their belief that it is compliant with all of the Directives that apply to it. The person that actually signs it, is personally accountable for that Declaration, and can as an individual face prosecution, fines and even imprisonment if the Declaration is made falsely. They will be the first point of call for surveillance authorities if corrective action is required and they will be asked to substantiate the basis of their Declaration. A degree of authority or proven expertise in the product area is appropriate for the signee, who also should have access to assessment processes and potentially the necessary authority to take corrective action if there turns out to be a problem with the product or documentation. 4. Not including enough data in the Declaration to enable good traceability Product traceability is one of the key benefits of the CE Marking system. It requires manufacturers to be accountable for the compliance of their product. Whilst not all non-compliance is dangerous to the product user, all non-compliance does still require corrective action to bring a product into compliance with the rules. Every manufacturer selling into the EU with products subject to CE Marking has to obey the rules. There are no exceptions. Adequate contact data needs to be included on the Declaration so the manufacturer can be easily reached by the surveillance authorities in the event of an issue being highlighted, and information such as an identifying product number like a product batch, model or serial number, helps issues to be identified in specific groups of products. 5

6 5. Not including in the name and identification number of the Notified Body that performed their conformity assessment When manufacturers get their products tested to EU Harmonised Standards which they use as the evidence on which to base their Declaration, they often involve accredited companies called Notified Bodies to conduct the tests. Whilst including test reports and certificates in the technical file that accompanies the product is obvious, adding the name and identification number of the Notified Body to the Declaration can get forgotten. Demonstrating independent accredited assessment of product can be viewed by some as making the technical file more robust, and again adds to the traceability of the product. How Intertek can help Working with manufacturers to ensure that products meet the requirements of European Directives that relate to them is a core activity for Intertek. Our experts can provide support and guidance at every point during the process - from design review and pre-compliance testing to full testing to Standards and stringent professional assessment. Whether you need advice on factory production control, building a technical file or even how CE Marking should be applied, we can help. Whether you need evidence to support your CE Marking and DoC activities or a full product certification and Marking, Intertek an EU Notified Body- has a compliance route to meet your needs. About Intertek Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries, Intertek supports companies success in the global marketplace, by helping customers to meet end users expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. For more information on specific testing and certification information, please contact Intertek at , info.uk@intertek.com, or visit our website at This publication is copyright Intertek and may not be reproduced or transmitted in any form in whole or in part without the prior written permission of Intertek. While due care has been taken during the preparation of this document, Intertek cannot be held responsible for the accuracy of the information herein or for any consequence arising from it. Clients are encouraged to seek Intertek s current advice on their specific needs before acting upon any of the content. 6