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Medical Devices European Commission Healthcare

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 121

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This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

White & Case LLP

First International Procurement Instrument case relating to EU medical devices in China’s public procurement market. The key...

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On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more

K&L Gates LLP

COVID-19: European Commission Details Plans to Postpone EU Medical Device Regulation and European Derogation Procedure to Get...

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The European Commission (EC) has published details of its proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. In addition, the EC proposes introducing a new procedure to address...more

Hogan Lovells

European Commission publishes factsheet on medical devices and in vitro medical devices for non-EU and non-EEA competent...

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Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more

Hogan Lovells

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

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On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more

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