CE Mark - What are the Obligations of Manufacturers?

  • When placing their medical device in EU market  legal manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in the relevant Directive
  • Manufacturers shall cooperate with authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.
  • Manufacturers found  a product which they have placed on the market is not in conformity with the applicable directive shall immediately take the necessary corrective measures to bring that product into conformity or  to withdraw it or recall it from the market as per the vigilance control or recall procedure. Manufacturer shall inform Member States in which they made the product available to that effect, giving complete details about the device with cause and  corrective actions taken.
  • Manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, CAPA should be maintained as per Vigilance control procedure.
  • Manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable in a demonstrable fashion. All manufacturers shall draw up an EC declaration of conformity and affix the CE Mark.
  • Manufacturers shall keep the Technical File and Declaration of conformity for the life of the device placed in the market.
  • Manufacturers shall ensure that changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken and informed the NB accordingly.
  • Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users as per the directive.
  • Manufacturers shall ensure traceability of the device that their products bear a type, batch or serial number.
  • Manufacturers shall indicate their name, registered trade name / mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. 

INDIA – Bangalore
+ 91 994 591 2081
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+49 2161 990 8831
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