CE Marking Services What is CE Marking? Many products that are placed on the single market in the European Economic Area (EEA) (28 EU countries, together with Iceland, Liechtenstein and Norway) contain a marking with the letters CE affixed. CE marking is a conformity marking which stands for Conformité Européene" which literally means "European Conformity". CE marking general principles are governed by the Regulation (EC) No 765/2008, which defines the requirements for accreditation and market surveillance relating to the market of products. 1 The meaning of CE marking is a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in Community harmonisation legislation providing for its affixing 2 This implies that by placing the CE marking on a product, a declaration is made by the concerned manufacturer that he bears the sole responsibility to comply to the applicable health, safety and environmental protection legislation, together with all relevant product legislative requirements before having the product placed in the market. Also, the manufacturer shall ensure validity for the product that is put on the EEA market. What are the benefits of CE marking? CE marking is regarded as a passport for products to enter and circulate freely within the 30 counties forming part of the EEA. This facilitated path to European Market entry was brought about by the harmonisation of the product requirements legislation across Europe. This means that once the manufacturer ensures legal compliance to affix the CE marking, products will have access to all different member states of the EEA without the need to adapt to specific and conflicting requirements of different member states of the EEA. In tandem, implementation of these requirements enhances product safety and reliability, which in turn diminish the risk of customer dissatisfaction and associated liability claims. Which products require CE marking? CE marking is mandatory, for all products that need to get access to the EEA market and are covered by the scope of at least one or more European Union harmonised directives (examples are found below). On the contrary, products that are not within the field of application of the European Union harmonised acts are not allowed to be CE marked. 1 Regulation (EC) No. 765/2008, 9 July 2008 2 Article 2.20 of Regulation (EC) No. 765/2008, 9 July 2008
Tuning Fork provides producers based in China with the following services:- 1. EU Documentation and Standards Delivery Service. 1.1 EU Product Directives 1.2 European Standards 1.3 Other EU Official Documents 2. Technical Consulting Service 2.1 Technical Advice on Compliance Engineering 2.2 Safety and Risk Assessments 3. Compliance Testing Service 3.1 Pre-compliance testing arrangement 3.2 Full-compliance testing arrangement 4. Technical Documentation Service 4.1 Technical Files (Technical Documentation): guiding to prepare for this document. 4.2 EC Declaration of Conformity: guiding and preparing this document, in several languages. 5. Labeling and Document Translation: Arrange the translation from English into the official language(s) of every EU member state 5.1 Users Manual and Installation Instructions 5.2 Labeling Advice and Translation 6. European (EEA/EU) Authorised/Authorized Representative Service 6.1 Use of Tuning Fork Name & Address and offices: 6.2 Product Registration: register products with MDD/IVD products in EEA with the Competent Authority (CA) by acting as a European Authorised/Authorized Representative. 6.3 Renewal and Update Product Registration: update product registration information whenever it changes 6.4 Keep Technical Files: 6.5 Legislation Monitoring: monitor and report new developments in European product legislation relevant to products. 6.6 Vigilance and Incident Reporting: assist with product vigilance and incident reporting. 6.7 Product Recalls and Advisory Notices: assist with Product Recalls and the issuing of Advisory Notices
What is the CE marking process? Phase 1: Identify the applicable EU Directive(s) and harmonised standards The EU Directive(s) applicable to the product that is intended to the EEA market should be identified, so as to establish whether the product requires CE marking or not. The product should then is assessed for conformity to the essential requirements in the applicable directive(s) that covers both the design and production phases of that product. The manufacturer then identifies and implements harmonized European standards that are applicable to the product that is intended for CE marking. Phase 2: Identify the conformity assessment procedure Conformity assessment consists of a process that the manufacturer is responsible for carrying out, to demonstrate that the applicable requirements in the EU directives have been fulfilled. This process is laid down under the Decision No 768/2008 EC. There are eight different conformity assessment procedures called modules (named with letters A to H), some of which have variants. The manufacturer shall choose one or two conformity assessment modules to ensure directive(s) compliance to cover both design and production phases. The distinct conformity Assessment modules and their descriptions are outlined below. Phase 3: Conduct a conformity assessment of the product Each of these modules lay down distinct responsibilities on the manufacturer and determine various routes of conformity depending on the applicable directive(s) and risk classification of the product. In essence, conformity assessment routes include: Assessment of the product by the manufacturer, without third party involvement. This option is applicable in case of low complexity in design and production mechanism and thus the product carries low risk for the public interest (e.g. Module A). Assessment of the product by the manufacturer, together with additional requirement for mandatory audits carried out by a notified body chosen by the manufacturer. Some such modules are based on quality assurance techniques derived from the EN ISO 9000 3 and EN ISO 9001 4 standards (e.g. modules D, E and H). This applies for products with more design complexity and increased public risk when in use. Assessment of the product conducted by a notified body involving services such as product testing and type examination certification issue, together with mandatory audits carried out by a notified body chosen by the manufacturer (e.g. module H). This applies for products where design is complex and risk to user s safety is very high. 3 Quality management systems Fundamentals and vocabulary 4 Quality management systems Requirements
Phase 4: Compilation and maintenance of technical documentation Following, the achievement of a positive conformity assessment result for your product a technical file needs to be compiled. This consists of a range of technical documentation (e.g. technical descriptions, bills of materials, specifications, test reports, instructions for use and EU declaration of conformity (EU DoC) )that verifies compliance to the EU directive(s) with respect to the design, development and production of the product. The technical documentation (including the EU declaration of conformity) must be kept for 10 years after the last item of the product has been placed on the market. Certain directives (such as the council directive 93/42/EEC for medical devices as amended by Directive 2007/47/EC) 5, has a requirement that the manufacturer appoints an authorized representative in the European union, that is in a position to provide the technical file on request of a market surveillance authority. In addition, certain directives specify that if the manufacturer does not have a registered place of business in the EEA, the name of address of the authorized representative in the European Union should be present on the label, outer packaging and product instructions. 6 Phase 5: Preparation and maintenance the EU Declaration of conformity The manufacturer or authorized representative established in the EU must complete and sign an EU declaration of conformity which assumes responsibility for the compliance of the product to the applicable EU directive(s). In terms of content, this declaration contains a list of directives and harmonized European standards that the product is conforming to, product identification, manufacturer and authorized representative name, address and approval. Phase 6: Product registration in the EU Certain classes of products such as medical devices, require to be formally registered in EEC and then there is a certificate of registration issued. Phase 7: Affix CE mark on product and/or packaging CE marking must be affixed to the product in a legible and indelible manner or to its packaging if it is not possible on account of the nature of the product. Also, the CE marking must be affixed to any documentation accompanying the product. CE marking should not be affixed on the product in advance of conformity assessment procedure completion and as a result it is expected to be at the end stages of the production process. When the conformity assessment procedure requires a notified body to be involved in the production phase, the identification number of the notified body must accompany the CE marking. 5 Directive 2007/47/EC, 05 September 2007 6 Directive 2007/47/EC, 05 September 2007
CE Marking Process
Products requiring CE marking 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 and Directive 2014/29/EU) Toys' safety (Directive 2009/48/EC) Electrical equipment designed for use within certain voltage limits (Directive 2006/95/EC and Directive 2014/35/EU) Machinery (Directive 2006/42/EC) Electromagnetic compatibility (Directive 2004/108/EC and Directive 2014/30/EU) Measuring instruments (Directive 2004/22/EC and Directive 2014/32/EU) Non-automatic weighing instruments (Directive 2009/23/EC and Directive 2014/31/EU) Cableway installations designed to carry persons (Directive 2000/9/EC) Radio equipment and telecommunications terminal equipment (Directive 1999/5/EC and Directive 2014/53/EU) 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 and Directive 2014/68/EU) Transportable Pressure equipment (Directive 2010/35/EU) Aerosol Dispensers (Directive 75/324/EEC as amended) Lifts (Directive 95/16/EC and 2014/33/EU Recreational craft (Directive 94/25/EC and Directive 2013/53/EU) Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 94/9/EC and Directive 2014/34/EU) Explosives for civil uses (Directive 93/15/EEC and Directive 2014/28/EU)
Pyrotechnics (Directive 2013/29/EU) Regulation on the Labeling of Tyres (Regulation (EC) No 1222/2009) Personal protective equipment (Directive 89/686/EEC) Marine equipment (Directive 96/98/EC and Directive 2014/90/EU) 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 labeling (Directive 2010/30/EU)
Overview of Modules 7 Modules A Internal Production Control A1 Internal production control plus supervised product testing B EU-type examination Description A + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer. A + product checks at random intervals carried out by a notified body or in- house accredited body. Covers design. It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated. A notified body examines the technical design and or the specimen of a type and verifies and attests that it meets the requirements of the legislative instrument that apply to it by issuing an EU-type examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type. C Covers production and follows module B. based on internal production control Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B. C1 Covers production and follows module B. based on internal production control plus supervised product testing Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B. C + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer. C2 Covers production and follows module B. based on internal production control plus supervised product checks at random intervals Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B. C + product checks at random intervals tests on specific aspects of the product carried out by a notified body or in-house accredited body. 7 The Blue Guide on the implementation of EU products rules 2016. (2016). Official Journal of the European Union, C(272/01).
D based on quality assurance of the production process Covers production and follows module B. The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EU- type. The notified body assesses the quality system. D1 Quality assurance of the production process The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to legislative requirements (no EU-type, used like D without module B). The notified body assesses the production (manufacturing part and inspection of final product) quality system. E Covers production and follows module B. based on product quality assurance E1 Quality assurance of final product inspection and testing The manufacturer operates a product quality (= production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system. The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D (and D1 too) aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process The manufacturer operates a product quality (= production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to the legislative requirements (no module B (EU-type), used like E without module B). The notified body assesses the quality system. The idea The idea behind module E1 is similar to the one under module D1: both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final product, while the quality system under module D1 aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E1 is thus similar to module D1 without the provisions relating to the manufacturing process. F Covers production and follows module B. based on product verification The manufacturer ensures compliance of the manufactured products to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to EU-type. Module F is like C2 but the notified body carries out more systematic product checks.
F1 Conformity based on product verification G Conformity based on unit verification H Conformity based on full quality assurance H1 Conformity based on full quality assurance plus design examination The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to the legislative requirements (no EU-type, used like F without module B) Module F1 is like A2 but the notified body carries out more detailed product checks. The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type). The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system. The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system and the product design and issues an EU design examination certificate. Module H1 in comparison to module H provides in addition that the notified body carries out a more detailed examination of the product design. The EU-design examination certificate must not be confused with the EU-type examination certificate of module B that attests the conformity of a specimen 'representative of the production envisaged', so that the conformity of the products may be checked against this specimen. Under EU design examination certificate of module H1, there is no such specimen. EU design examination certificate attests that the conformity of the design of the product has been checked and certified by a notified body.