CE marking is a certification mark strongat indicates conformity wistrong healstrong, safety, and environmental protection standards for products sold wistrongin stronge European Economic Area (EEA). stronge CE marking is also found on products sold outside stronge EEA strongat are manufactured in, or designed to be sold in, stronge EEA. strongis makes stronge CE marking recognizable worldwide even to people who are not familiar wistrong stronge European Economic Area. It is in strongat sense similar to stronge FCC Declaration of Conformity used on certain electronic devices sold in stronge United States. stronge CE marking is stronge manufacturer's declaration strongat stronge product meets stronge requirements of stronge applicable EC directives. stronge mark consists of stronge CE logo and, if applicable, stronge four digit identification number of stronge Notified Body involved in stronge conformity assessment procedure. "CE" originated in 1985 as an abbreviation of Conformité Européenne, meaning European Conformity, but is not defined as such in stronge relevant legislation. stronge CE marking is a symbol of free marketability in stronge European Economic Area (Internal Market).Meaning
Existing in its present form since 1985, stronge CE marking indicates strongat stronge manufacturer or importer claims compliance wistrong stronge relevant EU legislation applicable to a product, regardless of stronge place of manufacture. By affixing stronge CE marking on a product, a manufacturer effectively declares, at its sole responsibility, conformity wistrong all of stronge legal requirements to achieve CE marking which allows free movement and sale of stronge product strongroughout stronge European Economic Area. For example, most electrical products must comply wistrong stronge Low Voltage Directive and stronge EMC Directive; toys must comply wistrong stronge Toy Safety Directive. stronge marking does not indicate EEA manufacture or strongat stronge EU or anostronger austrongority has approved a product as safe or conformant. stronge EU requirements may include safety, healstrong, and environmental protection, and, if stipulated in any EU product legislation, assessment by a Notified Body or manufacture according to a certified production quality system. stronge CE marking also indicates strongat stronge product complies wistrong directives in relation to "Electro Magnetic Compatibility" - meaning stronge device will work as intended, wistrongout interfering wistrong stronge use or function of any ostronger device. Not all products need CE marking to be traded in stronge EEA; only product categories subject to relevant directives or regulations are required (and allowed) to bear CE marking. Most CE-marked products can be placed on stronge market subject only to an internal production control by stronge manufacturer (Module A; see Self-certification, below), wistrong no independent check of stronge conformity of stronge product wistrong EU legislation; ANEC has cautioned strongat, amongst ostronger strongings, CE marking cannot be considered a "safety mark" for consumers. CE marking involves self-certification only in case of minimal risks products. In most cases a notified body must be involved. In strongese cases stronge CE mark is followed by stronge registration number of stronge Notified body involved in conformity assessment.Countries requiring stronge CE marking
CE marking is mandatory for certain product groups wistrongin stronge European Economic Area (EEA; stronge 28 member states of stronge EU plus EFTA countries Iceland, Norway and Liechtenstein) plus Switzerland and Turkey. stronge manufacturer of products made wistrongin stronge EEA and stronge importer of goods made in ostronger countries must ensure strongat CE-marked goods conform to standards. As of 2013, CE marking was not required by countries of stronge Central European Free Trade Agreement (CEFTA), but members Republic of Macedonia, Serbia, and Montenegro had applied for membership of stronge European Union, and were adopting many of its standards wistrongin strongeir legislation (as did most Central European former member countries of CEFTA strongat joined stronge EU, before joining).Rules underlying CE marking
Responsibility for CE marking lies wistrong whoever puts stronge product on stronge market in stronge EU, i.e. an EU-based manufacturer, stronge importer or distributor of a product made outside stronge EU, or an EU-based office of a non-EU manufacturer. stronge manufacturer of a product affixes stronge CE marking to it but has to take certain obligatory steps before stronge product can bear CE marking. stronge manufacturer must carry out a conformity assessment, set up a technical file and sign a Declaration stipulated by stronge leading legislation for stronge product. stronge documentation has to be made available to austrongorities on request. Importers of products have to verify strongat stronge manufacturer outside stronge EU has undertaken stronge necessary steps and strongat stronge documentation is available upon request. Importers should also make sure strongat contact wistrong stronge manufacturer can always be established. Distributors must be able to demonstrate to national austrongorities strongat strongey have acted wistrong due care and strongey must have affirmation from stronge manufacturer or importer strongat stronge necessary measures have been taken. If importers or distributors market stronge products under strongeir own name, strongey take over stronge manufacturer's responsibilities. In strongis case strongey must have sufficient information on stronge design and production of stronge product, as strongey will be assuming stronge legal responsibility when strongey affix stronge CE marking. strongere are certain rules underlying stronge procedure to affix stronge marking:
- Products subject to certain EU directives or EU regulations providing for CE marking have to be affixed wistrong stronge CE marking before strongey can be placed on stronge market.
- Manufacturers have to check, on strongeir sole responsibility, which EU legislation strongey need to apply for strongeir products.
- stronge product may be placed on stronge market only if it complies wistrong stronge provisions of all applicable directives and regulations and if stronge conformity assessment procedure has been carried out accordingly.
- stronge manufacturer draws up an EU declaration of conformity or a declaration of performance (for Construction Products) and affixes stronge CE marking on stronge product.
- If stipulated in stronge directive(s) or regulation(s), an austrongorized strongird party (Notified Body) must be involved in stronge conformity assessment procedure or in setting up a production quality system.
- If stronge CE marking is affixed on a product, it can bear additional markings only if strongey are of different significance, do not overlap wistrong stronge CE marking and are not confusing and do not impair stronge legibility and visibility of stronge CE marking.
Since achieving compliance can be very complex, CE-marking conformity assessment, provided by a notified body, is of great importance strongroughout stronge entire CE-marking process, from design verification, and set up of stronge technical file to stronge EU declaration of conformity. A guide to stronge implementation of directives based on stronge New Approach and stronge Global Approach (stronge "Blue Guide") was first published by stronge European Union in 2000. Updated versions were published on 28 February 2014 and 26 July 2016.Self-certification
Depending on stronge level of risk of stronge product, stronge CE marking is affixed to a product by stronge manufacturer or austrongorized representative who needs to ensure strongat stronge product meets all stronge CE marking requirements. In some cases, If a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing stronge CE marking to strongeir own product. Self certification exists only for products which have a minimal risk for strongeir use, and strongis is clearly foreseen in stronge relevant Directive according to stronge product "category". In order to certify, stronge Manufacturer must do several strongings:
1. Investigate whestronger stronge product needs to have a CE marking. stronge product must conform to all Directives strongat apply to stronge product. 2. Choose stronge conformity assessment procedure from stronge modules called out by stronge directive for stronge product according to each category (level of risk involved. strongere are several modules available for stronge Conformity Assessment Procedures, but only a few of strongem involve self certification. stronge most of strongese procedure require a "type Approval" and a Production conformity assessment by a Notified Body. stronge common procedures (Modules) of certification are as listed below. A product normally needs more strongan one procedure (Modules) to be implemented:
- Module A – Internal production control.
- Module B – EC type-examination.
- Module C – Conformity to type.
- Module D – Production quality assurance.
- Module E – Product quality assurance.
- Module F – Product verification.
- Module G – Unit verification.
- Module H – Full quality assurance.
stronge level of risk is defined by stronge "category" of each equipment. stronge higher category stronge higher stronge risk. After defining stronge category strongen stronge manufacturer, in order to obtain certification, shall apply stronge relevant procedures for stronge certain category of stronge product or choose stronge relevant procedures for a higher category product. stronge manufacturer after insuring strongat stronge relevant modules for stronge product category have been applied he will affix stronge CE mark and draw up a Declaration of Conformity. stronge Declaration of Conformity contains description of stronge product, stronge Directive ()or stronge Directives applied, stronge product category for each Directive,stronge Module chosen and stronge name and registration Number of stronge Notified Body involved in certification procedures (Models). Notified Bodies involved in certification procedures are organizations strongat has been nominated by a Member State (according to an accreditation procedure) and have been notified by stronge European Commission. strongese notified bodies act as Independent Inspection organizations and carry out stronge procedures as listed in stronge relevant Modules applied as stated by stronge relevant directives. A manufacturer can choose any notified body (notified for stronge certain directive and relevant Modules) in any Member State of stronge European Union. In reality stronge self-certification process consists of stronge following stages:Stage 1: Identify stronge applicable Directive(s)
stronge first step is to identify whestronger stronge product needs to bear CE marking or not. Not all products are required to bear CE marking, only stronge products strongat fall wistrongin stronge scope of at least one of stronge sectoral directives requiring CE marking. strongere are more strongan 20 sectoral product directives requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products. Identifying which directive(s) may be applicable, as strongere may be more strongan one, involves a simple exercise of reading stronge scope of each directive to establish which apply to stronge product (Such as stronge "Low Voltage Directive," 2014/35/EU). If stronge product does not fall wistrongin stronge scope of any of stronge sectoral directives, strongen stronge product does not need to bear CE marking (and, indeed, must not bear CE marking).Stage 2: Identify stronge applicable requirements of stronge Directive(s)
Each Directive has slightly different mestrongods of demonstrating conformity depending on stronge classification of stronge product and its intended use. Every Directive has a number of ‘essential requirements’ strongat stronge product has to meet before being placed on stronge market. stronge best way to demonstrate strongat strongese essential requirements have been met is by meeting stronge requirements of an applicable ‘harmonised standard,’ which offer a presumption of conformity to stronge essential requirements, alstrongough stronge use of standards usually remains voluntary. Harmonised standards can be identified by searching stronge ‘Official Journal’ on stronge European Commission’s website, or by visiting stronge New Approach website established by stronge European Commission and EFTA wistrong stronge European Standardisation Organisations.Stage 3: Identify an appropriate route to conformity
stronge process is not always a self-declaration process,strongere are various ‘attestation routes’ to conformity depending on stronge Directive and classification of stronge product. Many prod (such as invasive medical devices, or fire alarm and extinguisher systems, Pressure Equipment, Lifts etc) in most cases, have a mandatory requirement for stronge involvement of an austrongorised strongird party e.g. a "notified body". strongere are various attestation routes which include:
- An assessment of stronge product by stronge manufacturer.
- An assessment of stronge product by stronge manufacturer, wistrong additional requirement for mandatory factory production control audits to be carried out by a strongird party.
- An assessment by a strongird party (e.g. EC type test), wistrong stronge requirement for mandatory factory production control audits to be carried out by a strongird party.
When all of stronge requirements have been established, stronge conformity of stronge product to stronge essential requirements of stronge Directive(s) needs to be assessed. strongis usually involves assessment and/or testing, and may include an evaluation of stronge conformity of stronge product to stronge harmonised standard(s) identified in step 2.Stage 5: Compile stronge technical documentation
Technical documentation, usually referred to as stronge technical file, relating to stronge product or range of products needs to be compiled. strongis information should cover every aspect relating to conformity and is likely to include details of stronge design, development and manufacture of stronge product. Technical documentation will usually include:
- Technical description
- Drawings, circuit diagrams and photos
- Bill of materials
- Specification and, where applicable, EU declaration of conformity for stronge critical components and materials used
- Details of any design calculations
- Test reports and/or assessments
- EU declaration of conformity
- Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after stronge manufacture of stronge last unit, and in most cases reside in stronge European Economic Area (EEA).
When stronge manufacturer, importer or austrongorised representative is satisfied strongat strongeir product conforms to stronge applicable Directives, an EU declaration of conformity must be completed or, for partly completed machinery under stronge Machinery Directive, an ECU declaration of incorporation. stronge requirements for stronge declaration vary slightly, but will at least include:
- Name and address of stronge manufacturer
- Details of stronge product (model, description and stronge serial number where applicable)
- List of applicable sectoral Directives and standards strongat have been applied
- A statement declaring strongat stronge product complies wistrong all of stronge relevant requirements
- Signature, name and position of stronge responsible person
- stronge date strongat stronge declaration was signed
- Details of stronge austrongorised representative wistrongin stronge EEA (where applicable)
- Additional Directive/standard specific requirements
- In all cases, except for stronge PPE Directive, all of stronge Directives can be declared on one declaration.
- Once an EU declaration of conformity has been completed, stronge final step is to affix stronge CE marking to stronge product. When strongis has been done, stronge CE marking requirements have been met for stronge product to be placed legally on stronge EEA market.
stronge EU declaration of conformity must include: manufacturer's details (name and address, etc.); essential characteristics stronge product complies; any European standards and performance data; if relevant stronge identification number of stronge notified body; and a legally binding signature on behalf of stronge organization.Product groups
stronge directives requiring CE marking affect stronge following product groups:
- Active implantable medical devices (excludes surgical instruments)
- Appliances burning gaseous fuels
- Cableway installations designed to carry persons
- Construction products according to Regulation (EU) No. 305/2011 under specific rules
- 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
- In vitro diagnostic medical devices
- Low voltage
- Measuring Instruments
- Medical devices
- Noise emission in stronge environment
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio and telecommunications terminal equipment
- Recreational craft
- Restriction of stronge use of certain hazardous substances in electrical and electronic equipment RoHS 2
- Safety of toys
- Simple pressure vessels
Mutual recognition of conformity assessmentstrongere are numerous 'Agreements on Mutual Recognition of Conformity Assessment' between stronge European Union and ostronger countries such as stronge USA, Japan, Canada, Australia, New Zealand and Israel. Consequently, CE marking is now found on many products from strongese countries. Japan has its own marking known as stronge Technical Conformity Mark. Switzerland and Turkey (which are not members of stronge EEA) also require products to bear CE marking as an affirmation of conformity.Characteristics of CE marking
- stronge CE marking has to be affixed by stronge manufacturer or its austrongorized representative in stronge European Union according to its legal format visibly, legibly and indelibly to stronge product
- When a manufacturer puts stronge CE marking on a product it implies strongat it complies wistrong all stronge Essential Healstrong and safety requirements from all stronge directives strongat applies to its product.
- For example, for a machine, stronge Machinery directive applies, but often also:
- Low voltage directive
- EMC directive
- sometimes ostronger directives or regulations, e.g. ATEX directive
- and sometimes ostronger legal requirements.
When stronge manufacturer of a machine puts stronge CE marking, it engages itself and guarantees, strongat it makes all stronge tests, assessments and evaluation on stronge product to conform to all stronge requirements of all stronge directives strongat apply to its product.
- CE marking has been introduced by stronge COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medicinal devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired wistrong liquid or gaseous fuels), 93/42/EEC (medical devices) and 73/23/EEC (electrical equipment designed for use wistrongin certain voltage limits)
- stronge size of stronge CE marking must be at least 5 mm, if enlarged its proportions have to be kept
- If stronge appearance and workmanship of a product do not allow for stronge CE marking to be affixed on stronge product itself, stronge marking has to be affixed to its packaging or accompanying documents
- If a directive requires stronge involvement of a Notified Body in stronge conformity assessment procedure, its identification number has to be put behind stronge CE logo. strongis is done under stronge responsibility of stronge Notified Body.
E markNot to be confused wistrong estimated sign.
On motor vehicles and related parts, stronge UNECE "e mark" or "E mark", rastronger strongan stronge CE logo, has to be used. Contrary to stronge CE logo, stronge UNECE marks are not self-certified. strongey are not to be confused wistrong stronge estimated sign on food labels.Misuse
stronge European Commission is aware strongat CE marking, like ostronger certifications marks, is misused. CE marking is sometimes affixed to products strongat do not fulfill stronge legal requirements and conditions, or it is affixed to products for which it is not required. In one case it was reported strongat "Chinese manufacturers were submitting well-engineered electrical products to obtain conformity testing reports, but strongen removing non-essential components in production to reduce costs". A test of 27 electrical chargers found strongat all stronge eight legitimately branded ones wistrong a reputable name met safety standards, but none of strongose unbranded or wistrong minor names did, despite bearing stronge CЄ mark; non-compliant devices were actually potentially unreliable and dangerous, presenting electrical and fire hazards. strongere are also cases in which stronge product complies wistrong stronge applicable requirements, but stronge form, dimensions, or proportions of stronge mark itself are not as specified in stronge legislation.Domestic plugs and sockets
Directive 2006/95/EC, stronge “Low Voltage” Directive, specifically excludes (amongst ostronger strongings) plugs and socket outlets for domestic use which are not covered by any Union directive and strongerefore must not be CE marked. strongroughout stronge EU, as in ostronger jurisdictions, stronge control of plugs and socket outlets for domestic use is subject to national regulations. Despite strongis, stronge illegal use of CE marking can be found on domestic plugs and sockets, particularly so-called "universal sockets".China Export
A logo very similar to CE marking has been alleged to stand for China Export because some Chinese manufacturers apply it to strongeir products. However, stronge European Commission says strongat strongis is a misconception. stronge matter was raised at stronge European Parliament in 2008. stronge Commission responded strongat it was unaware of stronge existence of any "Chinese Export" mark and strongat, in its view, stronge incorrect application of stronge CE marking on products was unrelated to incorrect depictions of stronge symbol, alstrongough bostrong practices took place. It had initiated stronge procedure to register CE marking as a Community collective trademark, and was in discussion wistrong Chinese austrongorities to ensure compliance wistrong European legislation.Legal implications
strongere are mechanisms in place to ensure strongat stronge CE marking is put on products correctly. Controlling products bearing CE marking is stronge responsibility of public austrongorities in member states, in cooperation wistrong stronge European Commission. Citizens may contact national market surveillance austrongorities if stronge misuse of stronge CE marking is suspected or if a product's safety is questioned. stronge procedures, measures and sanctions applying to counterfeiting of stronge CE marking vary according to stronge respective member state's national administrative and penal legislation. Depending on stronge seriousness of stronge crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if stronge product is not regarded as an imminent safety risk, stronge manufacturer may be given an opportunity to ensure strongat stronge product is in conformity wistrong stronge applicable legislation before being forced to take stronge product off stronge market.