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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

CE marking makes

Europe’s marketyours!

Source: ec.europa.eu/CEmarking

what is ce marking

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

what is ce marking1

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

what is ce marking2

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

what is ce marking3

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 steps for ce m a rking

6 steps for CE marking

Source: ec.europa.eu/CEmarking

step 1 identify the directive s and harmonised standards applicable to the product

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

step 1 identify the directive s and harmonised standards applicable to the product1

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

step 1 identify the directive s and harmonised standards applicable to the product2

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

step 2 verify the product specific requirements

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

step 3 independent c onformity assessment

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

step 4 test

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

step 5 technical documentation

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

step 6 affixation of the ce marking

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

slide15

ROHS

Source: ec.europa.eu/CEmarking

slide16

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

ROHS

Source: ec.europa.eu/CEmarking

slide17

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

slide18

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