EuroSynth Specification

Introduction

CE, FCC, RCM and related regulatory compliance

This is a very grey area at the moment but really requires significant investigation.

ANY product that is imported for resale or is manufactured for sale and contains electrical mains circuitry, MUST be submitted for regulatory compliance and subsequently carry the authorised marking for that compliance. The actual requirements for passing certification vary in different countries and it is the responsibility of the manufacturer and/or importer to be aware of those requirements and to ensure that those products meet the requirements.

Similarly, any product utilising RF technologies such as Wi-Fi, Bluetooth and networking, or include high-speed switching technology such as microcontrollers, digital circuitry or switching technology, should also be checked to see if they require certification.

Kits or modules that contain any of the above items may NOT be exempt from regulatory compliance.

CE Countries

Importers and distributors help ensure that only products compliant with EU legislation and bearing the CE marking are placed on the extended Single Market of the EEA. As they are the intermediaries between manufacturers and traders, they must have overall knowledge of the legal requirements and make sure that the products they distribute or import meet them.

Importers

When importing from non-EU countries, importers must check that products fulfil all EU safety, health and environmental protection requirements before placing them on the market.

The importer has to verify that:

  • the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market
  • the necessary documentation such as the EU Declaration of Conformity (27 KB) and the technical documentation is available upon request
  • contact with the manufacturer is possible at any time

Distributors

Distributors must handle the product carefully and they mustn’t affect its compliance with EU legislation. The distributor has to know which products must bear the CE marking and the accompanying documentation. They should be able to identify products that are not in compliance.

Distributors must be able to demonstrate to national authorities that they:

  • have confirmation from the manufacturer or the importer that the necessary measures have been taken
  • are able to assist national authorities in their efforts to receive the required documentation

If importers or distributors market the products under their own names, they take over the manufacturer’s responsibilities. In this case, they must have sufficient information on the design and production of the product because they will be assuming the legal responsibility when affixing the CE marking.

Manufacturers

Manufacturers play a crucial role in ensuring that products placed on the extended Single Market of the EEA are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.

Manufacturers play a crucial role in ensuring that products placed on the extended Single Market of the EEA are safe. They are responsible for checking that their products meet EU safety, health, and environmental protection requirements. It is the manufacturer’s responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.

If you are a manufacturer, you have to follow these six steps to affix a CE marking to your product:

  1. Identify the applicable directive(s) and harmonised standards
  2. Verify product specific requirements
  3. Identify whether an independent conformity assessment (by a notified body) is necessary
  4. Test the product and check its conformity
  5. Draw up and keep available the required technical documentation
  6. Affix the CE marking and draw up the EU Declaration of Conformity (27 KB).

These six steps may differ by product as the conformity assessment procedure varies. Manufacturers must not affix CE marking to products that don’t fall under the scope of one of the directives providing for its affixing.

For further details https://ec.europa.eu/growth/single-market/ce-marking_en

Ignorantia juris non excusat or ignorantia legis neminem excusat

"ignorance of law excuses no one" is a legal principle holding that a person who is unaware of a law may not escape liability for violating that law merely because one was unaware of its content.

!!! You Are Warned !!!


RoHS and WEEE

Although currently not applicable in all countries, all products should be RoHS compliant where applicable. This means that all components and materials used in the production of products must be RoHS compliant and RoHS procedures should be used during all assembly and handling processes.

 

Email:  elby-designs@bigpond.com
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