Medical Innovation Exchange

MDR

European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance  

European Commission Proposes Extended Timeline for EU MDR/IVDR Compliance       On January 6, the European Commission adopted a proposal to give more time to certify medical devices under EU MDR to mitigate the risk of shortages. The proposal now needs to be adopted by the European Parliament and the Council. The proposal introduces a …

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FDA Highlights Exemptions for Real World Data-identified AEs

FDA Highlights Exemptions for Real World Data-identified AEs     On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) …

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FDA CDRH Releases Proposed Guidances for 2023

FDA CDRH Releases Proposed Guidances for 2023     The Center for Devices and Radiological Health (CDRH) has published a list of guidance documents it intends to publish in 2023. The list is prioritized by an “A-List” of documents it intends to publish, and a “B-List” of documents it intends to publish as resources permit. In …

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Streamlining the Literature Review Process

Streamlining the Literature Review Process     Literature reviews play an integral role in the regulation of medical devices and technologies. We spoke with Evidence Partners’ CEO Peter O’Blenis to learn more about the challenges of literature reviews, their role in supporting patient safety and global regulatory approval, as well as new tools that help medtech …

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