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 effect, replacing the previous EU directive (98/79/EC). In 2022, after a 5-year transition period, it will be binding for all in-vitro diagnostics manufacturers and economic players in the EU, 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:

– The new regulatory framework from an implementation perspective

– OEM-PLM constellations and Laboratory Developed Tests (LDTs)

– UDI and EUDAMED

– Essential safety measures and reports

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

The event will take place on 20.09.2019 from 9:30 a.m. to 3 p.m. at the premises of TaylorWessing at Ebertstraße 15, 10117 Berlin. This free of charge event will take place in German and offer a platform for solution-oriented discussions.

The registration is possible at registration@noSpamkalmsconsulting.com.