Counting down to the MDR date of application, and the legal stuff to get right before May 2020

Do you know that feeling that things look far away, but when you think about it are a lot closer than you think? This is the feeling that the first medical devices companies are having because are facing the reality that they might not be in time any more  to have a valid CE mark by the date of application, either because they did not timely renew their old CE mark, or because they are with a notified body that will likely not be accredited in time to process their conformity assessment application for an [...] « Read the rest of this article on medicaldeviceslegal »