06. October 2020

Are you well prepared for the new IVDR?


The new IVDR, coming into force on May 2022, will have major implications on your operations. The need of a notified body for app. 80% of products, even for existing ones, and the assignment of a Person Responsible for Regulatory Compliance (PRRC) are only some of them.

We at Effectum Medical have successfully mastered similar situations with our medical device clients – preparing for the change from MDD to MDR. It is our beliefs that this can only be achieved with a deep understanding of our customers needs and pains.

Participate in our 5 min “IVDR readiness survey”! As a thank you we will send you a white paper with key topics of the upcoming IVDR and market radar.