Do your Economic Operators need a Quality Management System?

Medical Device made Easy Podcast · Mar 4, 2020

We know that the Manufacturer of a Medical Device needs a Quality Management System, but what about the Importer, Distributor or Authorized Representative? Do they also need to show they have a system that guarantees that what they are distributing is correct? Erik Vollebregt from Axon Lawyers will help us understand what is written on the different texts. The answer is not easy as there is what is mandatory by EU MDR 2017/745 or EU IVDR 2017/746 and what is common sense. Can you be blamed because you don’t have an ISO 13485 certification? Don’t forget to review the other episodes…