Risks of Non-Compliance

Risks of Non-Compliance

Non-compliance with the Directive’s requirements will result in the removal of the device from the market and the revoking of the CE marking affixed on the device.

  • Product recall

(a) where a Member State establishes that the CE marking has been wrongly affixed,  the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;

(b)  where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the  market, in accordance with the procedure in Article 8.

2. The  provisions stated in paragraph 1 shall also apply where the CE marking  has been affixed in accordance with the procedures in the Directive,  but inappropriately, on products that are not covered by this Directive.

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