CE Marking and CE Declaration of conformity

CE marking of medical devices is mandatory on the European Union market.

Depending on the risk class of the medical device, you must implement adequate conformity assessment procedures that validate the technical file

and the quality management system.

Additionally, the traceability system to be adopted under the “new” regulations 2017/745 and 2017/756 requires the registration of economic operators (actors) and medical devices in order to obtain an SDR (single registration number) and UDI’s (Unique Device Identification), respectively.

Count on us to accompany you in all the steps necessary for the CE marking of your device and the respective issuance of the CE declaration of conformity:

  • Legal Framework
  • Design and Development Project Planning and Control
  • Assessment of compliance with essential requirements
  • Support for (pre-)Clinical evaluation
  • ISO 14971 Risk Assessment
  • Label and instructions for use
  • Eudamed, UDI, Infarmed records
  • CE Declaration of Conformity
  • Manufacturer’s post-market monitoring system
  • ISO 13485 and ISO 9001 certification
  • Preparation of technical files