Product liability for devices under MDR and IVDR

With the MDR and IVDR nearing completion in the trilogue negotiations the final outline of these two statutes become more and more clear. It looks now like the regulations will be agreed upon during this Presidency, which means they could be published in the Official Journal and enter into force this autumn. I’m referring to “they”, although there are some rumors now that since the remaining political difficulties are in the IVDR, it might be that the IVDR delay is adopted at a later stage [...] « Read the rest of this article on medicaldeviceslegal »