Content
The EU MDR introduces the EUDAMED database for the central management of medical devices in Europe. Included are actors, product master data, approval by notified bodies, vigilance, clinical studies and market observation. All EU MDR products and MDD products with reporting requirements are affected. EUDAMED implements a workflow for product registration, certificate request and reporting. The seminar conveys the tasks with EUDAMED from the manufacturer's perspective. It focuses on the strategic implementation of the EU MDR at the manufacturer or system and procedure pack producer.
Topic overview
- EU MDR implementation: timetable, information sources MDCG and CAMD
- Overview UDI
- EUDAMED database: Overview with an introduction to the Actor, Device, UDI, Certificate and Vigilance modules and their processes
- Actor Registration Module: SRN and strategic considerations for changes
- Vigilance module: Create reports in EUDAMED
- Group ID “BASIS-UDI-DI” in concept and implementation
- Hierarchy of packaging levels and procedure packs
- Fields and rules for products in the UDI module
- Communication with EUDAMED: computer connection, download or web forms
target group
Regulatory Affairs, QM, Marketing.
Prior knowledge
Affinity to medical devices and databases. It is recommended to attend the seminar “Implementation of UDI according to EU-MDR – medical device marking” in advance.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
