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.
With a sense of desperation building among stakeholders over the challenges in ensuring all products are compliant with the Medical Device Regulation in time, high-level solutions are being considered. But a further MDR delay is not an option.
The time to create a flexible, risk-based regulatory system for all in vitro diagnostics is now, Pew tells US lawmakers, and offers suggestions to improve draft legislation that aims to do just that.
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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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