Content
The seminar teaches manufacturers' obligations regarding the Medical Devices Regulation 2017/745 and the German Medical Devices Law Implementation Act in order to be able to place a medical device on the market in Europe.
The main focuses are:
- Basic principle EU declaration of conformity
- Creation of a basic UDI structure for the product range
- Other applicable product codes
- Tasks BfArM and ZLG
- Selection and communication notified body
- Registration in EUDAMED – what information is needed
- Display medical devices related to initial placing on the market in DMIDS
Topic overview
- Basic UDI structure
- Authorities
- Notified Bodies
- EUDAMED
- DMIDS
target group
Exclusively for graduates of the “Regulatory Affairs Manager Module 1” certificate course.
Prior knowledge
Entry level/beginners/little experience/actually different focus of the job.
KONTAKT:
Online
