Source: ec.europa.eu/CEmarking CE marking makes Europe’s market yours!

What is CE marking? 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 By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area

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

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

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

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

Source: ec.europa.eu/CEmarking Electrical Safety: Low Voltage Directive Electrical Safety: Low Voltage Directive Electromagnetic Compatibility (EMC) Electromagnetic Compatibility (EMC) Low Voltage Directive (LVD) 2006/95/EC Low Voltage Directive (LVD) 2006/95/EC Electromagnetic Compatibility (EMC) Legislation: Directive 2004/108/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 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 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. 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

STEP 2 – Verify the product- specific requirements Source: ec.europa.eu/CEmarking 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 3 – independent conformity assessment Source: ec.europa.eu/CEmarking Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in 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 Body is indeed required.

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

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

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

ROHS Source: ec.europa.eu/CEmarking

ROHS The RoHS directive aims to restrict certain dangerous substances commonly used in electronic and electronic equipment.

ROHS Source: ec.europa.eu/CEmarking 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 Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm

ROHS Source: ec.europa.eu/CEmarking 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.

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