The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.
The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”
The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.
Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?
The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from usual medical device rules was granted recently. But not for IVDs, where the situation is described as “grim.”
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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