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Non-Compliant Products


When a Member State discovers that a product carrying the CE Marking which is being used for the purposes intended may endanger the health or safety of people and potentially cause damage to goods or the environment, it is the responsibility of the manufacturer or their authorised EU representative to re-establish the product’s compliance with CE Marking regulations and to rectify the infringement of the conditions established by that Member State.

Should non-compliance persist, the Member State must take all necessary steps to remove the product from the market, prohibit it from being put on the market, placed into service or freely circulated. In addition, the Commission must be informed immediately of the steps taken, along with the reasons for the decision, particularly if non-conformity is due to:

  • Non-compliance with the applicable essential requirements
  • Inadequate application of the harmonised standards and other regulations which provide presumption of conformity with the applicable directive/s.
  • Lack of standards which provide presumption of conformity with the applicable directive/s.

This marks the start of a consultation process between the Commission and the parties involved (the Member State and whoever is responsible for the product). This process enables the Commission to assess whether the restrictive measure is justified, applying the safeguard clause.

In the case of an incident caused by a defective spare part, liability will be determined through application of the Council Directive 85/374/CEE.

It is in the interest of the manufacturer to note in the maintenance manual that, if this is the case, liability will only be assumed if the original device was defective, but will have diminished responsibility or it will become the responsibility of whomever replaced the component if the user failed to follow the instructions and used unauthorised spare parts.

There are, however, a range of valid situations in which it is possible to present products without the CE Marking. These are:

  • Products that do not comply with the Community provisions in force can be presented at trade fairs, exhibitions and demonstrations provided that a visible plaque clearly indicates their non-compliance and states that it is not possible to acquire the products until the manufacturer or their EU representative has taken the necessary steps to ensure they comply with the essential requirements. In the case of product demonstrations, the necessary safety precautions should be adopted to ensure the adequate protection of those present.
  • Products manufactured for export to non-EU countries.
  • Certain products covered by the directives but exempt from the CE Marking such as safety components covered by the Machinery Directive
  • Insubstantial repair or modification of devices previously manufactured in the European Union.