With the EU Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the MDR, and introducing new products. Although the Medical Device Coordination Group (MDCG) guidance has been forthcoming, there remain significant gaps in guidance and interpretation of requirements, and varying interpretations of expectations. In addition with the limited number of Notified Bodies designated under the MDR, there is substantial pressure to make MDR submissions as soon as possible to avoid the “cliff edge” of May 2024. NAMSA invites you to join this upcoming webinar as our team of regulatory experts discuss practical insights to address these challenges.
Regulatory & Reimbursement
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For patients on Medicare, the majority of whom are over age 65, time matters. However, newly published research from the Stanford Byers Center for Biodesign shows that patients can wait up to 5 years after FDA authorization to access new medical technologies. Instead, a well-designed transitional coverage program could greatly accelerate patients’ access to care, while reducing the overall cost burden on our healthcare system. This program would also encourage innovation in areas of critically important unmet clinical needs. The Duke-Margolis Center for Health Policy has recommended the addition of several key elements to a transitional coverage pathway, highlighting the need for early engagement between stakeholders to inform and guide evidence development and appropriate use of novel technologies. Please join us to explore these findings and hear the perspectives of physicians, innovators and CMS stakeholders on this important initiative to advance patient care. |
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