There are often numerous misunderstandings concerning CE marking – who it is for, what it means and who needs it. This blog aims to unpick, debunk and clarify some of these misconceptions, starting with the basics.

What does ‘CE’ mean?

CE is an abbreviation of the French phrase ‘Conformité Européene’ which literally translates as ‘European Conformity.’ Although the phrase ‘CE Mark’ is sometimes used in newspapers and other articles on the subject, the official, correct term is ‘CE Marking’ and this is what is used in the various product directives.

What does CE Marking mean?

The CE Marking serves as a declaration from the manufacturer that their product complies with the essential requirements of the relevant European health, safety and environmental legislation laid out in the different product directives. Once a product has been awarded the CE Marking, then it is able to move freely within the European Free Trade Association (EFTA) and the European Union (EU). It also means that customs and other enforcement authorities are permitted to withdraw non-conforming products.

What products need the CE Marking?

The process of establishing whether or not a product requires the CE Marking is somewhat complex. Manufacturers need to establish:

  • What countries they want the product to be introduced in to. Countries within the European Economic Area (EEA) or EFTA will require the CE Marking if the product is covered by one or more of the CE Marking directives.
  • If Turkey is a target market. Whilst neither a member of the EU nor considered part of the EEA, Turkey has implemented a number of the CE Marking Directives, meaning that many products here will also require CE Marking.

The following product categories are covered by at least one of the CE marking directives:

  • Medical devices
  • Active implantable medical devices
  • In vitro diagnostic medical devices
  • Construction products
  • Machinery
  • Electrical equipment
  • Electronic equipment
  • Personal protective equipment
  • Pressure equipment
  • Simple pressure vessels
  • Gas appliances
  • Radio and Telecommunications terminal equipment
  • Lifts
  • Cableways
  • Equipment and protective systems for use in explosive atmospheres
  • Explosives for civil use
  • New hot water boilers
  • Measuring Equipment
  • Non-automatic weighing instruments
  • Toys
  • Recreational craft

The following product categories do not require CE Marking:

  • Cosmetics
  • Foodstuffs
  • Chemicals
  • Pharmaceuticals

However, cosmetics and other products still fall under the scope of other European or national legislation (and usually the General Product Safety Directive 2001/95/EC if no specific legislation is applicable) they just do not require any marking.

Looking for CE Marking advice for your product? Obelis has many years of experience offering consultation and guidance to manufacturers of medical devices and cosmetic, chemical and technology products looking to introduce their designs and productions to the EU market. Contact Us.

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