MDR 2017/745 COMPLIANCE
Compliance with the MDR 2017/745 involves meeting a series of regulatory tasks to ensure medical devices meet European Union requirements. Below is the structured compliance checklist:
| Sr.# | Task Description |
|---|---|
| 01 | Single Registration Number (SRN#) |
| 02 | Classification of medical devices (Chapter V, Annex VIII) |
| 03 | GSPR (General Safety and Performance Requirements) (Annex I) |
| 04 | Label and Instruction for Use (IFU) (Annex I) |
| 05 | DOC (Declaration of Conformity) (ANNEX IV) |
| 06 | UDI Codes (Article 27, 28) |
| 07 | EMDN Coding (Article 26) |
| 08 | Registration of devices on EUDAMED (Article 29, ANNEX VI) |
| 09 | Integration with QMS (13485) documentations (Article 10) |
| 10 | Technical file (Annex II & III) |
| 11 | Conformity Procedures (Article 52) |