January 13, 2021

[FEATURED] COVID-19 And FDA: Official Tells How Pandemic Has Affected Agency’s Regulatory Work

US FDA device center associate director Erin Keith explained how the agency adapted – and continues to adapt – to the COVID-19 pandemic when it comes to medical device and diagnostic regulation.

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January 6, 2021

[FEATURED] EU Industry Is Largely Ready For Brexit: This Is Why

Brexit will be painful economically for medtech and create more work for companies in the remaining 27 EU countries who want to sell to Great Britain and Northern Ireland. But much has been done to mitigate the degree of pain once expected.

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December 29, 2020

[FEATURED] Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos

Latest EU survey predicts unprecedented hike in demand for notified body assessments between 2021 and 2024 and insufficient notified body capacity under the Medical Device Regulation.

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December 22, 2020

[FEATURED] EU Notified Bodies Demand IVDR System Readiness Or Deadline Review By Year End

If the tools are not in place by the end of 2020 to allow diagnostics companies to comply with the EU IVDR, the 2022 compliance deadline should be delayed, say EU notified bodies.

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December 8, 2020

[FEATURED] Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid

Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?

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