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EU CE Marking

All medical devices must depending on their Intended Use comply with one of the directives:

  • Active Implantable Medical Devices (AIMDD)
    Directive 90/385/EEC - OJ L189/ 20.7.90
  • In Vitro Diagnostic Directive (IVDD)
    Directive 98/79/EC - OJ331/ 7.12.98
All directives are fully implemented in all EU member states.
 

DMD Consulting can help your company to comply with European CE Marking requirements including:

  • Determining product classification including combination products 
  • Identifying an appropriate conformity assessment route to the CE mark including establishing required Quality Management System
  • Developing the Technical File/Dossier including compliance with the Essential Requirements 
  • Complying with Post-Market Surveillance requirements 
  • Selection of suitable Notified Body for premarket certification of device or Quality Management System
  • Complying with other regulatory requirements.