
Workshop: New EU regulation and approval of medical devices and in vitro diagnostics (MDR)
In cooperation with the renowned Johner Institute (https://www.johner-institut.de/), CeNTech GmbH is organizing a one-day training seminar on the new European Medical Device Regulation on 16 June 2020. Participation is free of charge for SMEs (funding via the Interreg project MATMED), the number of participants is limited to 10 – 12 people.
The EU has significantly tightened regulation and approval for medical devices and in-vitro diagnostics. The new regulations will come into force as early as 2020 (Medical Device Regulation) and 2022 (in-vitro diagnostics). This represents quite a challenge for many companies. The one-day seminar at CeNTech on 24 March 2020 (Tuesday) from 9.00 – 17.00 at CeNTech will address the following points:
- Classification of medical devices
- Conformity assessment procedures
- Basic safety and performance requirements
- Technical documentation
- Requirements for quality management systems and their auditing
- Development process
- Post-market surveillance and vigilance
- Clinical evaluation and post-market clinical follow-up