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Regulatory Affairs, Medical Devices
MedTech eBook Series

Clinical Evaluations for Medical Devices and IVDs - MedTech eBook Series

Posted by on 12 October 2020
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Click the image above or here to explore the report.

While the EU MDR has been delayed until 26 May 2021, allowing medical device, software, and combination product manufacturers an extra year to ensure their systems comply with the regulatory requirements, the challenges created by COVID-19 has made this complex implementation even more so.

Here in this interactive eBook, MedTech Summit takes an in-depth look at how the EU MDR will affect clinical evaluations for medical devices and IVDs in numerous ways, making the regulation more stringent. Industry experts offer insights on Clinical Evaluation Reports (CERs), “sufficient clinical evidence”, Post-market clinical follow-up (PMCF) and much more, including:

  • EU Devices And Diagnostics Regulatory Outlook Through May 2021: What can medtech expect for the rest of 2020 and into the first half of 2021, in these unprecedented times? MedTech Insight explores.
  • EU Post-Market Clinical Follow Up: What Manufacturers Need To Know: In this interview, Sarah Sorrel, a leading EU expert and consultant on clinical data issues, discusses with Medtech Insight what post-market clinical follow-up will entail.
  • Differences in Clinical Evaluations and Investigations under the EU MDR: This whitepaper assesses new expectations for clinical evaluations and investigations under the EU MDR.
  • Industry Voices: Preparing for the EU MDR clinical changes: We spoke with Basil Akra, CEO at QUNIQUE, and Juliana Witte, Clinical Evaluation Manager of Clinical Operations at Institut Straumann AG, about how industry should be preparing for EU MDR clinical changes.

Click the image at the top of the page or here to explore the report.

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