The MDR proposal for extension – “Can the maker repair what he makes?”

On 6 January 2023 it finally happened: the moment that many had been waiting for – the MDR extension proposal finally dropped (see here for Commission provided background). It did not turn out to be what I expected in all respects. First, it contained also an amendment to the IVDR: a removal of the sell-off period at the end of each of the stacked grace periods, which makes this proposal very relevant for the IVDR as well. Secondly but logically it also contain an amendment for custom made dev [...] « Read the rest of this article on medicaldeviceslegal »