What Does MDR Bring
- Common Specifications (Part II, Article 9)
- Clinical Trials (Part VI, Annex XV)
- Post Market Surveillance (PMS) (Part VII, Annex III)
- UDI Codes (Part III, Annex VI)
- Implant Card (Part II, Article 18)
- EUDAMED Registration (Part III)
- European Representative (Part II, Article 11)
- Product Damage Insurance (Article 10, Chapter VI, Article 69)
- Person Responsible for Compliance (Part II, Article 15)
- Significant Changes (MDD<=>MDR)