The Competent Authorities for Medical Devices (CAMD) was established to enhance collaborative working, communication and surveillance of medical devices across Europe. With the introduction of the Medical Devices Regulations (the MDR and IVDR), two groups were set up within the CAMD: (i) the Transition Subgroup, which will develop guidelines on the application of the MDR/IVDR during the transitional period, and details of which aspects of the Regulations devices will have to meet to be placed on the market during this time, and (ii) the Implementation Taskforce to facilitate collaboration and cooperation during the implementation phase of the new Regulations.

Earlier this month, the Implementation Taskforce published a high-level MDR/IVDR Roadmap. The Roadmap is the first glimpse into the intentions of the Commission and authorities across the EU as to how the Regulations will be implemented, and the order in which key guidance and clarification will be developed.Continue Reading Roadmap on MDR/IVDR published