Is Progress on MDR and IVDR Happening Fast Enough?

One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), experts within the industry continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period. As always with the introduction of new regulations, there are early adopters who recognize that it is crucial to engage with the requirements sooner rather than later. This is especially true for the MDR and IVDR given the expected capacity limitation of notified bodies as we approach the application date. Yet as the new MDR does not grandfather devices that are already CE marked, the Competent Authorities for Medical Devices (CAMD) is still working on the rollout of its roadmap to assist manufacturers during this transition stage. Many suggest that progress is not happening fast enough and little guidance is readily available. Some experts maintain that the MDR and IVDR expectations have been clear for long enough and that sufficient public information is available, insisting that companies could (and should) have started earlier. But there are still calls for more clarity and concerns that precious resources aren’t being applied appropriately or efficiently. Industry and Institutions Healthcare institutions, for example, seem underprepared which is concerning seeing as they will no doubt experience significant changes under the MDR and particularly...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news