I see in practice that some companies are well on their way with implementing the new MDR and IVDR regulations, while a lot of others are not. It will be interesting where everyone will be by the time the transitional period of the MDR ends and then when the IVDR transitional period ends.
This post is intended to address some seemingly quite ingrained misunderstandings about the MDR and IVDR. If you don’t believe me, that’s fine. Double check with your international branch associations, MedTech [...] « Read the rest of this article on