Medical Devices & In-Vitro Diagnostic Trainings
EU Regulatory frameworks for medical devices & in-vitro diagnostics are continuously evolving. We have learned that a comprehensive understanding of the CE marking requirements plays a key role in providing a successful and sustainable product-to-market process.
Understand the general framework of the EU MDR and learn about classification rules, conformity assessment routes and technical file requirements. Address the essential requirements for in-vitro diagnostic devices and guarantee CE-marking of your devices under the EU IVDR.
Please find below an example of a training session:
- The EU Market & CE Marking Process
- Technical Documentation- definition & rules
- Role & definition of EU Authorities, Certification Bodies, Authorized Representatives & the Manufacturer
- Presentation of MDD & MDR- essential safety requirements & conformity assessments
- Introduction to MDR- scope, timeframe & differences with MDD
- MDR Classification Rules
- Clinical data & Post Market Surveillance
- Requirements for EUDAMED & UDI
For a more information on our MDR & IVDR training sessions, do not hesitate to contact us!
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