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Medical Devices Regulatory Requirements European Medicines Agency (EMA)

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Hogan Lovells

MDCG guidance for consultations of authorities on devices incorporating a medicinal product

Hogan Lovells on

On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more

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