medicaldeviceslegal.com comes through again with another fantastic post of 7 Dec 2013 by Erik Vollebregt of Axon Lawyers that is full of valuable information and is a good summary of where things stand and what is expected to happen when the EU Council meets to discuss the dossier of medical devices and IVDs revision (proposed regulations) for the last time before the end of the Lithuanian Presidency and considers some of the political fallout too. The European elections are in May 2014 and political careers are at stake as Erik discusses. Erik provides a nice summary document (consolidated document – not totally vetted though so use at your own risk, but a great resource document) for both the proposed Medical Devices Regulation & proposed IVDs Regulation that uses track changes to show the changes to the proposed regulations.
Thx Erik for an excellent post & your great resources too!