The EU Medical Device Regulation (MDR) was officially passed in May 2017 and manufacturers now have until 2020 to be fully compliant with all changes set forth within the new regulation.
Download this 30 min. webinar to better understand the changes that clinical affairs teams should prepare for now to be successful under the new regulation. Discussion points include:
- Impact on the clinical strategy
- Portfolio analysis
- Post-market clinical follow-up
- Changes to Notified Bodies
- Clinical evaluation and CER
- Transparency of information