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Cost of CE Marking - Medical Device

It is a good idea to know about the cost of CE Marking and various factors affecting CE Marking cost before you start the CE Certification process. The Cost for CE Marking vary from device to device and organization to organization. The cost of CE certification for same device manufactured by two different organizations may different.

For example Company A and Company B are manufacturing sutures and both are going for CE Certification, Company A is an old company with ISO 13485 Implemented and having done all tests required as per MDD standard whereas Company B is a new company and doesn't have ISO 13485 or required test results as per Harmonized standards, and having more variants under the scope of certification, quite naturally the cost for CE certification for Company B is much higher than Company A.

CE Marking cost depends on various factors like -

  • Medical Device class
  • Intended use of device
  • Number of variants
  • Harmonized standards applicable
  • New tests required as per harmonized standard
  • Components / parts are CE Certified or not
  • Having a contract manufacturer or not
  • Number of manufacturing facilities
  • Status of ISO 13485 implementation
  • Notified body selected
  • etc...