Remember the CAMD Roadmap (dating back to end 2017) that promised us a roll-out of MDR and IVDR items that were sometimes even marked ‘high priority’ and how that lifted our spirits (at the time)? Remember how this was supplemented with the Rolling Plan, which promised the roll-out of all roll-outs for 2019? I have […]
At the moment I spend a considerable amount of my lawyering time answering questions concerning Brexit problems. My first question back to the company is: what are your Brexit scenarios? Did you make a plan to cover the scenarios and follow through? Often the answer is “no, we don’t have a plan, because we don’t […]
As we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear: the transitional period in the MDR and likely the one in the IVDR is not actually a transitional period for […]