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Medical Devices Regulatory Agenda European Commission

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

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EU Emergency Response Update – Key Policy & Regulatory Developments No. 115

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This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more

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Reversal of Burden of Proof Under Proposal for a New EU Product Liability Directive

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In Short - The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more

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Covid-19 Key EU Developments, Policy & Regulatory Update No. 81

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COMPETITION & STATE AID - Competition- European Commission ramps up home searches of employees of companies suspected of potential competition breaches - On 5 April 2022, Maria Jaspers (Director of Cartel Directorate, DG...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 80

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COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more

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Covid-19 Key EU Developments, Policy & Regulatory Update No. 76

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COMPETITION & STATE AID - Mergers - DG COMP COVID-19 website and mailbox for informal guidance - DG COMP has established a dedicated COVID-19 website. The website includes a dedicated mailbox...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 71

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COMPETITION & STATE AID - Competition - Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit. ...more

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COVID-19 KEY EU Developments, Policy & Regulatory Update No. 70

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COMPETITION & STATE AID - State Aid - European Commission adopts revised Guidelines on State aid to promote risk finance investments- On 6 December 2021, the Commission published its Communication on Guidelines on...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 66

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Competition - European Commission comments on the future of competition policy - On 29 October 2021, Executive Vice-President and Competition Commissioner Margrethe Vestager provided remarks on the future of competition...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 65

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Competition - European Commission ramps up combat against cartels, including reigniting dawn raids - On 22 October 2021, Executive Vice-President and Commissioner for Competition Margrethe Vestager highlighted the...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 64

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European Commission adopts Communication on Energy Prices to tackle exceptional rise in energy prices - On 13 October 2021, the Commission adopted a Communication on Tackling Rising Energy Prices: a Toolbox for Action and...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 63

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State Aid - European Commission consults on proposed amendments to General Block Exemption Regulation - On 6 October 2021, the Commission opened its consultation with Member States and interested parties to comment on...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 62

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European Commission consults Member States on future of State aid Temporary Framework - On 30 September 2021, the Commission launched its consultation with Member States on a draft proposal to prolong the State aid...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 61

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European Commission releases State of the Union 2021 report, including on COVID-related State aid - On 15 September 2021, the Commission published the State of the Union 2021 report on the Commission’s work and...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 58

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

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COVID-19 Key EU Developments, Policy & Regulatory Update No. 57

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This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. LATEST KEY DEVELOPMENTS...more

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European Commission submits proposal postponing the date of application of the MDR by one year

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The European Commission has submitted a proposal to the European Parliament and to the Council for a Regulation amending Regulation (EU) 745/2017 on medical devices. The purpose of the amendment is to defer application of the...more

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