Medical Devices

Media Kompass is ready to help you determine the best regulatory affairs strategy for managing medical devices requirements in the European Union (EU).
As a medical device company, you have certain obligations set out by European regulations as well as local authorities.

  • Preparation of documentation for the approval of import / distribution of medical devices

  • Preparation of documentation for approval of service / maintenance activities for medical devices

  • Ensuring the personnel needed for conformity person

  • Vigilance for medical devices

  • Advertising for MD materials – evaluation of conformity/ elaboration

  • Manufacturer registration, authorized representatives of medical devices

  • Registration of medical devices in the national database of medical devices

  • Regulatory affairs

  • EU Authorized Representative

  • Record of economic operators in Eudamed

  • Post-market monitoring plan

  • PSUR

  • PMCF – Post-market clinical follow-up