Content
The introduction of the Medical Device Regulation (EU-MDR) has resulted in significant changes for manufacturers and other economic actors, whose detailed knowledge is the prerequisite for successful certification by a notified body. This also includes products without a medical purpose (Article XVI).
The seminar will address key changes compared to the MDD, ranging from the Essential Performance and Safety Requirements (GSPRs), technical documentation, classification and labeling of products (UDI system), clinical data requirements and market surveillance after the products have been placed on the market (PMS).
Topic overview
- Basic content of the EU MDR
- Basic Safety and Performance Requirements (GSPRs)
- Transition periods and validity of certificates (Article 120)
- Clinical Evidence Requirements
- Requirements for the market surveillance and reporting system (PMS/PMCF/PSUR)
- Classification of products
- EUDAMED database/UDI system
target group
This seminar is intended for all participants who have to deal with the EU MDR from the various areas of a company.
Prior knowledge
Knowledge of MDD.
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:
Online
