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)