medicaldeviceslegal

The MDR – where are we now?

There seem to be a lot of misunderstandings in the market about the current status of the MDR. Some think it’s finished (it’s not, at least not formally) and there is a lot of insecurity about when it will enter into force. Currently the MDR and IVDR are in the process of translation. The trilogue produced negotiated texts but these are still not perfect. Upon close reading one discovers typos and numbering issues as a result of the many amendments. When a group of people translates two very com [...] « Read the rest of this article on medicaldeviceslegal »