An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)
Looking to stay ahead of ever-evolving regulations governing medical devices?
In this webinar, we discuss the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they’re having on the medical device industry.
Vincent Balgos, Director of Medical Device Solutions at Jama Software and Saby Agai, Sr. Consultant at Jama Software, provide a high-level overview of the new regulations, along with general industry observations and future considerations for organizations with medical products marketed in the EU market area, including:
- New classifications, grandfathering clause, and risk management requirements
- The number of notified bodies, backlog, and remediation efforts for placed products
- Future considerations regarding the compliance compatibility of IVDR & FDA and traceability
Finally, learn how the Medical Device Framework in Jama Connect® can help streamline your compliance efforts and ensure your products meet all the necessary regulatory requirements.