News & Analysis as of

Supply Chain Medical Devices Risk Assessment

Akin Gump Strauss Hauer & Feld LLP

EU Ratifies Pioneering Artificial Intelligence Legislation

On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more

Hogan Lovells

European Commission adopts a Regulation on electronic instructions for use for MDR-covered devices

Hogan Lovells on

The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices Regulation can be provided in...more

Hogan Lovells

NHS medicine and device suppliers urged to carry out supply chain coronavirus risk assessment

Hogan Lovells on

At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

King & Spalding on

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

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