Content
The seminar will introduce the structure of the Clinical Assessment Report (CER) and show its connection to the Clinical Assessment Plan (CEP). In addition, the basic performance and safety requirements and their verification are covered in the CER. Participants will also be taught how to deal with the topics of “residual risks” and “equivalence comparison” under the EU MDR.
The seminar also answers questions about the clinical benefit for the patient and the requirements of the notified bodies for the aforementioned documents.
Topic overview
- Structure of the CER/connection to the CEP
- Essential performance and safety requirements (GSPRs) and their evidence in the CER
- Presentation of the clinical benefit for the patient
- Main target criteria: Proof of the safety and performance of the medical device
- Requirements of Notified Bodies (NBs)
- Dealing with residual risks
- Instructions for use (IFU) Do's/Don'ts (changes compared to the MDD)
- Equivalence comparison under EU MDR
target group
Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.
Prior knowledge
Knowledge of the EU MDR is recommended.
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
