The notified body conundrum

In my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for IVDR status (and the incredulous reactions that I received) I though it would be a good idea to update on notified bodies in general, and how they are doing with 26 November on the horizon. You will have marked 26 November in your calendar, because this is the date that your notified body can apply for accreditation under the MDR and IVDR. It&# [...] « Read the rest of this article on medicaldeviceslegal »