• 1. Common Specifications (Chapter II, Article 9)
  2. Clinical investigations (Chapter IV, Annex XV)
  • Post-Market Surveillance (Chapter VII, Annex III)
  1. UDI Codes ( Chapter III, Annex VI)
  2. Implant Card (Chapter II, Article 18)
  3. Eudamed Registration (Chapter III)
  • Authorised Representative
  • Damage compensation
  1. Person Responsible For Regulatory Compliance
  • Significant Changes (MDD<=>MDR)