"IVDR in Focus: Preparation and Critical Issues"

09:30 till 15:00

Since May 2017, the new EU regulation on In-vitro diagnostics 2017/746 has been in force and replaces the previous EU directive (98/79/EC). After a 5-year transition period, it will be binding for all in-vitro diagnostics manufacturers and economic players in the EU in about two years, with far-reaching consequences and challenges.

Kalms Consulting and TaylorWessing cordially invite you to the all-day event
"IVDR in Focus: Preparation and Critical Issues"

There will be presentations on the latest trends of the following topics:
• Practical implementation of the new regulation

  • Current status
  • What can we learn from the MDR?

• OEM-PLM constellations and Laboratory Developed Tests (LDTs)
• UDI and EUDAMED
• Clinical evaluation and safety measures

The focus of the event is on the practical implementation of IVDR requirements for manufacturers. The event will be supported by contributions from the Notified Body BSI and the contract research organization TRIGA-S.

The event will take place on 18.06.2020 from 9:30 a.m. to 3 p.m. at the premises of Kalms Consulting at Rheinstr. 45 - 46, Aufgang 1, 12161 Berlin. It is free of charge, takes place in German and offers a platform for solution-oriented discussions.

The event is aimed at in-vitro diagnostic medical device manufacturers, in particular management, board members, executives, employees in Regulatory Affairs and Project Management as well as Quality Managers.

We look forward to receiving your registration at registration@noSpamkalmsconsulting.com