The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for the MDR and IVDR implementation. But with major hurdles ahead, in July it was still the problems and not the successes taking centre stage.
With notified bodies under increasing IVDR workload pressure, their representative associations have come up with one solution that should help rationalize part of their job.
The European Commission has published an updated timeline for delivering the EU medical device database. Regarded as the cornerstone of the EU medical device and IVD regulations, the Eudamed database will have been delayed by four years and there are transition periods ahead.
The EU has published a total of 61 pages of technical specifications for the higher risk, Class D products under the new IVD Regulation.
June was characterized by an intense debate focused on shortfalls in the implementation of the EU MDR and IVDR, on who is to blame and how solutions can be found, as well as by news of some regulatory progress, at last, in the UK.
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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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