This 2 day seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Device Regulation (..
IVDR), provide case studies and share lessons learned so your organization can benefit from the mistakes of others.We will review the latest changes to the regulations effective and in force for 2020 and will draw out key developments and key dates with particular emphasis on requirements for US firms shipping materials, parts, and products to the European Union.
Reasons for the Medical Device Regulation
Structure and objectives of the MDR
Difference between the old requirements (MDD) and the new (MDR)
How to transition from the old directives to the new regulation
General safety and performance requirements (GSPR Annex 1)