The authorities are not your friend anymore; and neither are notified bodies

Have you seen Mr Robot? If not, watch that series. With the MDR and IVDR adoption in sight (currently scheduled for Q1 2017) I see a number of developments in the market, all converging on the higher standards that will be imposed under these new regulations. By way of update, there is movement in the dossiers of the MDR and IVDR. The first drafts of the translations have been circulated for consultation in the mean time (I have the Dutch versions for example) with final numbering (123 articles) – t [...] « Read the rest of this article on medicaldeviceslegal »