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  • Article

    Council Of The EU Agrees On Mandate On Measures To Advance Biotechnology Innovation In The EU

    The European Council has adopted a position on targeted amendments to health legislation aimed at streamlining regulations for genetically modified microorganisms and updating organ processing rules to reflect scientific advances. The proposed changes seek to create a more efficient regulatory process for certain GMMs meeting predetermined safety standards while enabling innovative approaches to organ transplantation that could extend the time between procurement and transplant.
    European UnionFood, Drugs, Healthcare, Life Sciences
    Bergeson & Campbell
    Bergeson & Campbell
  • Article

    CJEU Ruling Clarifies Scope Of Medical Device Definition

    The Court of Justice of the European Union has issued a preliminary ruling in Case C-427/24 Diagramm Halbach, establishing critical principles for determining whether products qualify as medical devices under the EU Medical Device Regulation. The judgment clarifies that manufacturer advertising alone does not determine medical device status, and that products must objectively perform medical purposes to fall within the regulatory definition.
Global
Consumer Protection
Arnold & Porter
Arnold & Porter
  • Article

    The EU Packaging And Packaging Waste Regulation: Why Life Sciences Companies Should Act Now

    The EU Packaging and Packaging Waste Regulation becomes applicable on 12 August 2026, replacing existing directives with a directly applicable regime governing packaging design, documentation, labelling and end-of-life management across the EU market. Life sciences companies manufacturing medical devices, IVDs and pharmaceuticals face significant compliance obligations, with narrow sector-specific exemptions that do not eliminate core requirements for conformity documentation, substance restrictions...
    AfghanistanConsumer Protection
    Arnold & Porter
    Arnold & Porter
  • Article

    The EU Data Act’s Access-by-Design Deadline: What Life Sciences Companies Need To Know Before September 2026

    The EU Data Act's September 2026 deadline introduces a new access-by-design requirement for connected medical devices and related services, but the practical impact may be more limited than manufacturers expect. This analysis examines what life sciences companies must do to comply with both the upcoming milestone and the broader set of obligations that have been in force since September 2025.
    European UnionPrivacy
    Arnold & Porter
    Arnold & Porter
  • Article

    The Proposed European Biotech Act, 100 Days On

    On December 16, 2025, the European Commission (the "Commission") published a proposal for a European Biotech Act (the "Proposed Biotech Act" or "Proposal").
    AfghanistanFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
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