Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)

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MEDDEV 2.7/1 – new guidelines on clinical evaluations

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EU to release NEW Medical Device Regulations!

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New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (more…) [...]

CE Marking


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| CE Marking Directive 93/68/EECThe DirectiveScopeCompliance |
CE Marking Explained in Video |

CE Marking Directive 93/68/EEC

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CE Marking Directive 93/68/EEC of July 22, 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery)89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic weighing instruments), 90/385/EEC (active implantable medical devices), 90/396/EEC (appliances burning gaseous fuels), 91/263/EEC (telecommunications terminal equipment), 92/42/EEC (new hot-water boilers fired with liquid or gaseous fuels) and 73/23/EEC (electrical equipment designed for use within certain voltage limits).

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The Directive

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The CE Marking Directive 93/68/EEC was adopted on July 22, 1993 in order to introduce a harmonized set of rules concerning the affixing and use of CE marking.

The abbreviation ‘CE’ comes from the French phrase ‘Conformité Européene’ which literally translates as ‘European Conformity.’

The CE marking on a product is a declaration from the manufacturer that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations laid out in the various product directives.

European Directives lay out non-negotiable safety and environmental criteria that products must meet in order to be introduced to the EU market. The CE marking is a sign that these requirements have been met.

The CE Marking Directive gives a comprehensive and detailed description of the CE initials, as well as any other marks specific to certain directives, and how conformity with these marks can be achieved.

Once the requirements have been met, the product must carry the CE marking. The marking must be no smaller than 5mm high. The grid is for information only and is not considered part of the marking. Also, the C and E are not formed by perfect semicircles.

The manufacturer must:

  • Be European
  • Have an official department located within the European Community
  • Have an official agent or representative willing to share the liability for the CE marking and hold the Declaration of Conformity.

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in CE Marking

The CE Marking of products is intended to support the free movement of goods within the European Economic Area. All products that bear CE marking must comply with all requirements of the applicable directives. Where a product carries appropriate CE marking, the member countries of the European Economic Area must allow the product to be placed on the market.

CE Marking directives cover many product areas. The current CE Marking directives are:


New Approach Directives that do not require CE Marking are:

  • Packaging and Packaging Waste 94/62/EC
  • High Speed Rail Systems 96/48/EC
  • Marine Equipment 96/98/EC

The Marking should be affixed to one of the following:

  • the product itself
  • the packaging of the product
  • the instructions for use
  • the guarantee certificate

By affixing the CE Marking to the product, the manufacturer is stating that the product meets the requirement of all relevant directives. It is up to the manufacturer to decide which directives are applicable.

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The manufacturer or supplier should use one of the product conformity assessment modules available within the directive to demonstrate that the product complies with the essential requirements. One of the most common options for product assessment is to apply the relevant standards to the product and/or prepare relevant documentation such as the Technical File. The CE Marking should be affixed legibly and indelibly to the product. The manufacturer should also prepare and sign a ‘Declaration of Conformity.’

Many of the CE Marking Directives include provision for the appointment of Notified Bodies. These are organizations appointed by the Member States in which they are based. Their details are ‘notified’ to the European Commission, who then publish these details in the Official Journal of the European Communities.

The specific functions of Notified Bodies regarding compliance assessment for specific products are defined by the directives. For most, the involvement of a Notified Body is only required for high-risk and safety-critical products.

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CE Marking Explained in Video

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