News & Analysis as of

Supply Chain Medical Devices European Commission

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

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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

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The European Commission proposes a new Pharmaceutical Strategy for the EU

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On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 22

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This regular update (no. 22 | 22 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more

Jones Day

Trade Controls in the EU: COVID-19 Measures at a Glance

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In response to the novel coronavirus ("COVID-19") pandemic, the European Union ("EU"), various Member States and the United Kingdom have adopted trade control measures aimed at avoiding shortages and ensuring the availability...more

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An update on cooperation in the life sciences industry: the European Commission’s framework for sending “comfort letters” on...

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The European Commission has published a Temporary Framework Communication to provide guidance to companies that are cooperating to ensure the supply and distribution of essential products – including medicines and medical...more

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European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

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The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more

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