Rob Packard Looking forward to seeing how the team is able to develop a consensus and improve the standard.

Arthur Brandwood The new MDR contains language that seems to depart from the current "reduce all risks at any cost" approach in the Z Annexes. Especially in the General Safety and Performance Requirements (Chapter I).

@Marcello Antunes - do you believe this will allow more sense to prevail in updating the standard and keep the very pragmatic approach already embodied in the current version? See http://brandwoodbiomedical.com/almost-there-final-text-of-european-medical-device-regulation-is-published/ for some discussion of this.

Marcelo Antunes Arthur, yes, I think the language in the new regulations are far more in line with historical and current risk management practices. Revised requirementa and new guidance in ISO 14971 and ISO TR 24971 will male this even more clear.