Practice

Medical Device Law

Bringing a medical device to market involves addressing a host of issues: regulatory approval, patents, financing, manufacturing, distribution, and more. After your product debuts, the challenges continue throughout its life cycle, from running compliance programs to responding to enforcement actions. And if you’re operating globally, the last thing you want to do is to oversee a patchwork of different firms in different locations.

Hogan Lovells Publications

MDR single report exemption and ASRs: Coming to an end for most reporters Medical Devices Alert

The Medical Device Reporting (MDR) regulation provides a mechanism for the U.S. Food and Drug Administration (FDA or the Agency), as well as medical device manufacturers, to identify and...

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Press Releases

Hogan Lovells rings in the New Year with 30 promotions to partner and 47 promotions to counsel

LONDON and WASHINGTON, D.C., 3 January 2019 – Global law firm Hogan Lovells today announced that 30 of its people have been promoted to partner effective 1 January across its global...

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Hogan Lovells Publications

FDA releases final guidance document on PMA manufacturing site change supplements Medical Device Alert

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA)...

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