CE Marking General Principles

General principles of the CE marking

The CE marking shall be affixed only by the manufacturer or his authorized 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/EECPressure Equipment (PED) - 97/23/EC

Transportable Pressure Equipment Directive - 99/36/ECSimple Pressure Vessels - 87/404/EECConstruction Products (CPD) - 89/106/EECLow Voltage Equipment (LVD) - 2006/95/ECElectromagnetic Compatibility (EMC) - 89/336/EECMachinery - 98/37/ECLifts - 95/16/ECPersonal Protective Equipment (PPE) - 89/686/EECToys - 88/378/EEC

Contact us for CE Marking: 09999974494, 9654656507

CE Technical File

Manufacturers of new products subject to European product safety Directives must collect and be able to assemble comprehensive information covering the design, construction, conformity assessment and use of the product to demonstrate how their product complies with all applicable Directives.  All CE marking directives require the manufacturer of the product to create a technical file which should contain the information required to show that the product properly complies with the requirements of the directives which apply to it. This is required so that as manufacturer you can demonstrate with appropriately detailed documentation, calculations and drawings, how your product complies with all relevant Directives, and so is safe during all phases of its life. Systematically assembling the technical file may also help you when undertaking the conformity assessment process for a particular product. The directives contain clauses which give some general details of the kind of information which will be required in the technical file, but this is couched in the most general of terms. As a general guide, the following items should be included: Block diagram Circuit diagrams General Arrangement drawing List of standards applied Records of risk assessments and assessments to standards Datasheets for critical sub-assemblies List of components or Part list Copies of markings and labels, if any User manual Test reports Quality control & commissioning procedures Conformity Declaration There is nothing to stop the file containing a great deal more information than is listed here - for instance copies of the engineering drawings for any bespoke parts could also be included. However, these should not be used to pack the file at the expense of the more relevant information on how the equipment operates and how it meets the safety objectives of the Directives. Of course, for simple products (e.g. household domestic appliances) the control philosophy may be so simple as to be self evident, in which case it is unnecessary for the file to include this information. Often, this sort of product will be the subject of a notified body report confirming compliance to a harmonised standard and a copy of the report should be included in the file. The importance of including a basic general description of the appliance cannot be overstated. Furthermore, the action of providing a properly documented description of the control system will often allow the designer to spot potential flaws in the logic of the operation.  Access to the Technical File It is important to understand that only the authorities given power to enforce the directives have a right to see the technical file. It does not need to be published or given to customers. With the exception of the Medical Devices Directive, there is no clear requirement that the file should be kept on EU soil. However, for a manufacturer based outside of the EU, any approach made by the authorities will initially come to the authorised agent or the importer of the goods, so they must have access to the file to be able to fulfil their legal obligations. Access to technical information may also be a condition of contract laid down by some customers. The Machinery Directive requires manufacturers based outside Europe to appoint someone within Europe to act as the contact point for their technical documents. More details of this requirement can be found on our DOC-EUPOINT pages. When should the technical file be created? Normally the technical file does not have to be permanently available in material form, nor located within the territory of the Community, provided it is capable of being assembled and made available in a reasonable period of time. Different directives treat the creation of the file with different priorities. The LVD strictly requires the manufacturer to have the file in place before the CE mark is applied, whereas the Machinery Directive says that the file does not have to be in constant existence and thereby provides for a period of grace in which it can be compiled. In practice, it usually makes sense to ensure the file is created early in the life of a product and is then kept up to date. For some directives the creation of the file and its assessment by a Notified Body are a pre-requisite for proper compliance with the Directives. This is the case for the higher classes of medical, personal protective equipment and for equipment for explosive atmospheres. Assessment of the technical file is also a requirement for Type Approval under the Machinery Directive. There are also other reasons why it makes sense to compile the file at the time the product is originally designed rather than waiting until a request is received from an enforcement body. Firstly, there is the problem that much of the information required for the file (particularly component data and supplier information) may no longer be available several years after the product design has been completed. Secondly, the file can for a useful repository for information on changes to the design or manufacturing processes used to make the product. Finally, if used correctly, the file can itself become a useful way to manage the process of properly completing the CE marking process: if a list of the contents required for the file is drawn up at an early stage then this list can be used to identify whether all of the necessary steps have been completed by identifying the relevant information in the file for each stage in the process. Delivery of the file The purpose of the Technical File is to provide evidence for an enforcement authority that the product has correctly completed the assessment and attestation procedures of the relevant directive(s). The enforcement authorities have the right to demand a copy of the file for up to 10 years after the last date on which the product(s) described in the file were made. This is by no means a trivial requirement - changes in personnel, company facilities, IT systems and file formats all represent major challenges to guaranteeing the availability of the required information and need to be considered carefully. The file must be delivered 'in material form' which may be taken to mean as a paper copy. In practice, however, the enforcement bodies are likely to be satisfied with an electronic version, and in fact may only demand specific sections of the file if their concerns relate to specific aspects of the product's compliance with the directives. The file has to be drawn up in a European language, and will normally be requested by the relevant enforcement body for the country and region in which the manufacturer of the product is located (the "Home Authority Principle"). The manufacturer is not obliged to translate the file before delivery to an enforcement authority from outside their home country.

Contact us for CE Marking: 09718380800, 9555577722

CE MARKING MINI GUIDE

CE MARKING MINI GUIDE 

 

'Does the CE Marking Apply?'The CE Marking applies only to products placed in the market or put intoservice in the European Economic Area, and only for a certain number of productgroups or product aspects. So to answer the question whether the CE Markingapplies, one has to determine first if the countries in which the products aregoing to be placed in the market or used are countries that require CE Marking.Secondly, it must be checked if the product, or some of its aspects, are withinthe field of application of the CE Marking regulations.1. The CE Marking is only applicable in the following countries:A) The twenty-seven Member States of the European Union (EU):Austria (became member in 1995)Belgium (Founder Member in 1957)Bulgaria (2007)Czech Republic (2004)Cyprus (2004)Denmark (1973)Estonia (2004)Finland (1995)France (FM 1957)Germany (FM 1957)Greece (1981)Hungary (2004)Ireland (1973)Italy, (FM 1957)Latvia (2004)Lithuania (2004)Luxembourg (FM 1957)Malta (2004)The Netherlands (FM 1957)Poland (2004)Portugal (1986)Romania (2007)Slovakia (2004)Slovenia (2004)Spain (1986)Sweden (1995)United Kingdom (Great Britain) (1973)B) The following three members of the European Free Trade Association (EFTA):IcelandNorwayLiechtensteinAlthough Switzerland is member of the EFTA, it does not directly apply the CEMarking. However, Switzerlandhas signed a mutual recognition agreement with the European Union. For some CEMarked products, the Swiss authorities presume they comply with the equivalentSwiss regulations.C) The following countries that seek to become Member States of the EuropeanUnion:- Turkey: Turkey has transposed many of the European CE Marking regulationsinto their national legislation, and requires CE Marking for many products.- Croatia:Most CE Marking regulations have been transposed in Croatian legislation.Products with CE Marking are going to be accepted as products presumed tocomply with Croatian legislation. Croatia is expected to become afull member of the EU in 2009-2010.- Bosnia and Herzegovina:Bosnia and Herzegovinahas started the process of transposing CE Marking regulations in their nationalstate legislation. Products with CE Marking are accepted as products presumedto comply with national legislation.- Albania:Albaniahas started the process of transposing CE Marking regulations in their nationalstate legislation. Products with CE Marking are accepted as products presumedto comply with national legislation.- FYR Macedonia:FYR Macedoniahas started the process of transposing CE Marking regulations in their nationalstate legislation. Products with CE Marking are accepted as products presumedto comply with national legislation.- Serbia:Serbiahas recently started to approximate towards membership of the European Union.It is expected that in the next years the CE Marking regulations will betransposed in their national state legislation, and that products with CEMarking are accepted as products presumed to comply with national legislation.- Montenegro:Montenegrorecently became an independent country. Its government has announced that itaims at membership of the European Union. It is expected that in the next yearsthe CE Marking regulations will be transposed in their national statelegislation, and that products with CE Marking are accepted as productspresumed to comply with national legislation.If your products are placed in the market in other than aforementionedcountries, the CE Marking does not apply.Next you should check whether the product can be considered to be of one of theproduct groups covered by the CE Marking regulations.2. The CE Marking is required only for the following types of products:-Toys-Machinery-Electrical equipment-Electronic equipment-Personal protective equipment-Pressure equipment-Medical devices-Active implantable medical devices-In vitro diagnostica-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-Measuring EquipmentThe CE Marking is NOT required for the following products:-Chemicals-Pharmaceuticals-Cosmetics-FoodstuffsOther than mentioned product groups do not require CE Marking.Products that are not covered by the European CE Marking regulations may fallwithin the scope of other European or national legislation. If there is nospecific legislation, the General Product Safety Directive (2001/95/EC)applies. This European Directives requires that products are safe, but is doesnot require any marking.Tomorrow, we will look at determining which CE Marking directives and whichEuropean harmonized standards apply. These documents contain the requirementsand CE certification procedures that must be applied before the CE Marking maybe affixed.


 

'Determine the Applicable CE Marking Directives and European Harmonized Standards'
Now we will look into the question how to determine which CE Marking regulationsand European harmonized standards apply.CE DirectivesCE Marking product requirements and certification procedures are laid down inEuropean technical regulations that are called 'directives'. There arecurrently almost 25 CE Marking directives for different product groups (e.g.machinery, toys, medical devices) or product aspects (e.g. electromagneticcompatibility). Please note also that more than one directive can apply to asingle product. For example, a machine with an electrical system and controlpanel is regulated by the Machinery Directive, the Low Voltage Directive andthe EMC Directive.Unfortunately, there is no list that tells you which products are covered bywhich directives. So, you must check every directive in order to determine ifit applies. European harmonized standardsEuropean harmonized standards, are product standards that have been developed,adopted and published by one of the three European standards bodies CEN,CENELEC or ETSI on a mandate by the European Commission. In other words, theEuropean legislator requested the European standards bodies to develop thesestandards. They are called 'harmonized', because the content of these standardsare harmonized with the content of the essential requirements of the directivesto which they pertain. For every CE Marking directive there is a list ofEuropean harmonized standards.The relationship between the CE Marking directives and the European harmonizedstandards is very strong. The CE Marking directives state that if your productmeets the relevant specifications of all appropriate European harmonizedstandards, it is automatically presumed to comply with the appropriate CEdirectives. In other words, if your product is approved according the Europeanharmonized standards, they can be affixed with the CE Marking, because they arepresumed to comply with the essential requirements of the CE Markingdirectives. So applying European harmonized standards provide the easiest wayof checking CE compliance.Of course it is complex to determine the applicable CE Marking directives and European harmonized standards. If you need our support, please go to:
www.cemarking.in

CE Marking Directives

Reference of directive/regulation	Subject of directive/regulation
2000/9/EC	Cableway installations
(EC) 1907/2006	Chemical substances (REACH)
89/106/EEC	Construction products (CPD)
(EU) 305/2011	Construction products (CPR)
(EC) 1223/2009	Cosmetics
92/42/EEC	Ecodesign – hot-water boilers
2010/30/EU	Ecodesign and energy labelling
2009/125/EC	Ecodesign and energy labelling
(EC) 1221/2009	Eco-management and audit scheme (EMAS)
2004/108/EC	Electromagnetic compatability (EMC)
94/9/EC	Equipment for explosive atmospheres (ATEX)
93/15/EEC	Explosives for civil uses
2009/142/EC	Gas appliances (GAD)
95/16/EC	Lifts
2006/95/EC	Low Voltage (LVD)
2006/42/EC	Machinery (MD)
2004/22/EC	Measuring instruments (MID)
93/42/EEC	Medical devices (MDD)
90/385/EEC	Medical devices: active implantable
98/79/EC	Medical devices: in vitro diagnostic
(EC) 765/2008	New legislative framework (NLF)
2009/23/EC	Non-automatic weighing instruments (NAWI)
94/62/EC	Packaging and packaging waste
89/686/EEC	Personal protective equipment (PPE)
97/23/EC	Pressure equipment (PED)
2007/23/EC	Pyrotechnic articles
1999/5/EC	Radio and telecommunications terminal equipment (RTTE)
2008/57/EC	Rail system: interoperability
94/25/EC	Recreational craft
2011/65/EU	Restriction of the use of certain hazardous substances (RoHS)
2009/105/EC	Simple Pressure Vessels
2009/48/EC	Toys safety

CE Marking in Delhi

CE MARKING CERTIFICATE                                                                                                              

The CE marking as it has been legally called since 1993 (per directive 93/68/EEC) (Decision 93/465/EEC), or formerly EC mark is a mandatory conformity marking for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer declares that the product conforms with the essential requirements of the applicable EC directives.
DE system can help you gain easier access into the European market by ensuring your product meets all the CE mark requirements.  If you manufacture or import products which fall into the scope of one or more of the New Approach Directives you will then need professional guidance on how to meet all the essential requirements of these directives. Before you can sell a medical device or IVD within Europe, you must obtain CE Marking certification and place a CE Mark (CE Marking) on your product. The CE Marking for medical devices is not a quality mark nor is it intended for consumers. It is a legally binding statement by the manufacturer that their product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVDD 98/79/EC) or the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), where applicable. If a Notified Body is required, the Notified Body's four-digit number would appear below the CE Marking symbol.

For CE marking contact no. 91-9654656507, 9718380800                                                                                                                                                                 Email:  desystemindia@gmail.com