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Source: ec.europa.eu/ CEmarking

CE marking makes Europe’s market yours!. Source: ec.europa.eu/ CEmarking. CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market . What is CE marking?. Source: ec.europa.eu/ CEmarking.

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Source: ec.europa.eu/ CEmarking

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  1. CE marking makes Europe’s marketyours! Source: ec.europa.eu/CEmarking

  2. CE marking is a key indicator of a product’s • compliance with EU legislation and • enables the free movement of products within the European market. What is CE marking? Source: ec.europa.eu/CEmarking

  3. By affixing the CEmarking on a product,a manufacturer is declaring, • on hissole responsibility, • conformitywith all of the legal requirementsto achieve CE marking • and therefore ensuringvalidity for that product to be sold throughout the EuropeanEconomic Area What is CE marking? Source: ec.europa.eu/CEmarking

  4. CE marking does not indicate that a product was made inthe EEA, but merely states that the product is assessedbefore being placed on the market and thus satisfies thelegislative requirements (e.g. a harmonised level of safety)to be sold there. What is CE marking? Source: ec.europa.eu/CEmarking

  5. The manufacturer has verified that the product complies with all relevant essential requirements, or • if it is necessary it examined by a notified conformity assessment body. What is CE marking? Source: ec.europa.eu/CEmarking

  6. 6 steps for CE marking Source: ec.europa.eu/CEmarking

  7. There are more than 20 directives setting out the productcategories requiring CE marking. • The essential requirementsthat products have to fulfil (e.g. safety) are harmonisedat EU level and are set out in general terms inthese directives. STEP 1 Identify the directive(s) and harmonised standards applicable to the product Source: ec.europa.eu/CEmarking

  8. Electrical Safety: Low Voltage Directive • Electromagnetic Compatibility (EMC) • Low Voltage Directive (LVD) 2006/95/EC • Electromagnetic Compatibility (EMC) Legislation: Directive 2004/108/EC STEP 1 Identify the directive(s) and harmonised standards applicable to the product Source: ec.europa.eu/CEmarking

  9. The Low Voltage Directive is one of the oldest directive It characterises both with a • conformity assessment procedure applied to equipment before placing on the Market and with • Essential Health and Safety Requirements (EHSRs) which such equipment must meet either directly or by means of harmonised standards. STEP 1 Identify the directive(s) and harmonised standards applicable to the product Source: ec.europa.eu/CEmarking

  10. It is up to you to ensure that your product complies with the essential requirements of the relevant EU legislation. Full compliance of a product to the harmonised standards gives a product the “presumption of conformity”with the relevant essential requirements. STEP 2 – Verify the product-specificrequirements Source: ec.europa.eu/CEmarking

  11. Each directive covering your product specifies whetheran authorised third party (Notified Body) must be involvedin the conformity assessment procedure necessary for CE marking. This is not obligatory for all products, so it is important to check whether the involvement of a Notified Bodyis indeed required. STEP 3 –independent conformity assessment Source: ec.europa.eu/CEmarking

  12. Testing the product and checking its conformity to theEU legislation (Conformity Assessment Procedure) is theresponsibility of the manufacturer. One part of the procedureis, as a general rule, a risk assessment. By applying the relevantharmonised European standards, you will be able to fulfil theessential legislative requirements of the directives. STEP 4 – Test Source: ec.europa.eu/CEmarking

  13. The manufacturer has to establish the technicaldocumentation required by the directive(s) forthe assessment of the product’s conformity tothe relevant requirements, and for the riskassessment. STEP 5- Technical documentation Source: ec.europa.eu/CEmarking

  14. The CE marking must be affixed by the manufacturer It must beaffixed according to its legal format visibly, legibly andindelibly to the product or its data plate. If a NotifiedBody was involved in the production control phase, itsidentification number must also be displayed. STEP 6- Affixation of the CE marking Source: ec.europa.eu/CEmarking

  15. ROHS Source: ec.europa.eu/CEmarking

  16. The RoHS directive aims to restrict certain dangerous substances commonly used in electronic and electronic equipment. ROHS Source: ec.europa.eu/CEmarking

  17. RoHS specifies maximum levels for the following six restricted materials: Lead (Pb): < 1000 ppm Mercury (Hg): < 100 ppm Cadmium (Cd): < 100 ppm Hexavalent Chromium: (Cr VI) < 1000 ppm Polybrominated Biphenyls (PBB): < 1000 ppm PolybrominatedDiphenyl Ethers (PBDE): < 1000 ppm ROHS Source: ec.europa.eu/CEmarking

  18. Any RoHS compliant component must have 100 ppm or less of mercury and the mercury must not have been intentionally added to the component. In the EU, some military and medical equipment are exempt from RoHS compliance. ROHS Source: ec.europa.eu/CEmarking

  19. YourCE-marked product is ready for the market. Ready Source: ec.europa.eu/CEmarking

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