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What is CE marking and do all products need CE marking?

October 11, 2021 by Maria Nyåkern

Not all products sold in the European Union (EU) need to bear CE marking. CE marking is only mandatory for those products that fall under the scope of one or more of the European Commission product directives or regulations.

These directives and regulations define essential requirements / general safety and performance requirements related to health, safety, and environmental issues that the products must meet in order to be placed on the European market.

What products need CE marking?

CE marking applies to the following product groups:

  1. active implantable medical devices
  2. appliances burning gaseous fuels
  3. cableway installations designed to carry persons
  4. construction products
  5. eco-design of energy-related products
  6. electromagnetic compatibility
  7. equipment for use in potentially explosive atmospheres (ATEX)
  8. explosives for civil uses
  9. hot-water boilers
  10. household refrigerators and freezers
  11. in vitro diagnostic medical devices
  12. lifts
  13. low voltage
  14. machinery
  15. measuring instruments
  16. medical devices
  17. noise emission in the environment
  18. non-automatic weighing instruments
  19. personal protective equipment
  20. pressure equipment
  21. pyrotechnics
  22. radio equipment and telecommunications terminal equipment
  23. recreational craft
  24. restriction of hazardous substances in electrical and electronic equipment
  25. safety of toys
  26. simple pressure vessels

CE marking does not apply to items such as:

  • chemicals
  • pharmaceuticals, including cosmetics
  • food and food-related things

See a list of product groups that are subject to CE marking legislation.

Directives and Regulations that apply to your product

Over 20 directives and regulations exist for the different product categories requiring CE marking. Some products may fall under more than one EU directive or regulation. See a list of EU product legislation.

Where EU directives or standards apply to your product, you must ensure it conforms to the specified essential requirements before you can trade your product freely in the EU market. 

CE marking process

Before you place a CE mark on your product, you must determine exactly which directives and regulations apply and ensure that your product complies with the essential requirements of all applicable EU legislation.

To learn now, read how to place CE marking on a product.

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Category iconCE Mark,  European Union,  IVDR,  MDR,  Medical Devices,  Medical Technology,  Notified Body

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AKRN Scientific Consulting S.L ha sido beneficiaria del Fondo Europeo de Desarrollo Regional cuyo objetivo es mejorar la competitividad de las Pymes y gracias al cual ha puesto en marcha un Plan de Marketing Digital Internacional con el objetivo de mejorar su posicionamiento online en mercados exteriores durante el año 2020. Para ello ha contado con el apoyo del Programa XPANDE DIGITAL de la Cámara de Comercio de Burgos.
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La empresa (AKRN Scientific Consulting S.L.) es beneficiaria del Programa “la Caixa” Empleo Joven de ayudas para el fomento de la contratación de personas jóvenes. Estas ayudas están cofinanciadas por el Programa Operativo de Empleo Juvenil / Iniciativa de Empleo Juvenil – Fondo Social Europeo y por la Fundación Bancaria “la Caixa”.

 

 

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