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Month: February 2023

European Parliament to Amend MDR/IVDR Transitional Provisions

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On 16 February 2023, the European Parliament voted to adopt an amendment that affects Article 120 and Article 110 of Regulations (EU) 2017/745 and (EU) 2017/746, respectively. The amendment only extends the transitional period for legacy medical devices, but also removes the sell-off period for both medical and in vitro diagnostic (IVD) devices.

U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

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During the COVID-19 Pandemic, the FDA CDRH put the hardest, longest and most intensive work into reviewing EUA applications for COVID-19 diagnostic tests. The result was a shift in how the FDA, MedTech manufacturers and CROs conduct work, which is still in place today.