MDCG guidance as pseudo-legislation

The MDR has been applicable for some time and the IVDR just became applicable. The MDCG has, since both regulations entered into force, issued more guidance documents for the MDR and the IVDR in a few years than were ever issued for the old directives in several decades. Sounds like progress! High fives all around in the MDCG. Look at us crank out guidance by the truckload for all mankind! Also, the effect of using regulations instead of directives and a more centralised governance structure like [...] « Read the rest of this article on medicaldeviceslegal »