🇨🇿 Clinical Evidence in Legacy Devices
The webinar is designed for manufacturers who have launched their devices under previous legislation, are awaiting their first MDR certification and are unsure whether their clinical evaluation will be sufficient.
Date
11 Dec 2024, 09:30 – 12:30
Online: Cisco Webex
About
The event is held in Czech language only!
If you are facing your first MDR certification and are unsure whether your clinical trial provides sufficient clinical evidence to demonstrate compliance with the MDR, you have come to the right place. We will explain in a structured way the issues described in the MDR and MDCG 2020-6, highlight typical problems using model examples, suggest solutions and help you to get a practical grip on the issue of clinical evidence for legacy devices in the clinical trial plan. Last but not least, we will share with you our experience with the assessment of this issue by notified bodies.
Lecturers:
Lýdie Hojková
Barbora Charvátová
Content:
explanation of basic concepts
structured analysis of the requirements of MDCG 2020-6 and MDR
typical problem areas and how to deal with them
clinical trial plan for legacy device
model examples of good and bad practice
experience with notified body assessments
Additional information:
during the webinar, participants will have the opportunity to ask questions
each participant will receive a certificate of participation
a PDF presentation will be sent to all participants
Participation fee:
3.900 CZK excluding VAT
100% cancellation fee applies after bindingly confirmed registration, but with the possibility of sending a replacement participant