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:
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: