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Update: AI-Enabled Medical Devices and IVDs Confirmed as “High-Risk”
Digital Omnibus Update. More time (up to August 2028) yet confirming that AI-enabled medical devices and IVDs stay subject to the AI Act.
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CJEU on distributor's verification obligations under MDR
Medical device (and IVD) distributors. CJEU confirms that distributors need not repeat the manufacturer’s classification or conformity assessment, but must perform a “consistency check” for obvious inconsistencies.
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Grundsatzentscheidung des EuGH zu den Pflichten von Medizinprodukte-Händlern
KI in Medizinprodukten - Orientierung im regulatorischen Doppelregime
EuGH-Generalanwalt zu den Händlerpflichten bei Medizinprodukten
Proposed Amendments to the EU Medical Device Regulation
A European Perspective #1 | The Commission’s proposed MDR/IVDR reform introduces substantial changes to certification, classification and compliance frameworks. Medical device companies should assess potential im-pacts early and prepare for a shifting regulatory landscape.
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The 2026 Pharma Package: A New Regulatory Framework for Medicinal Products in the EU
A European Perspective #1 | The EU’s largest pharmaceutical law reform in over 20 years introduces a new regulatory exclusivity framework, revised orphan drug incentives and an antimicrobial voucher. Strategic exclusivity planning will become essential for pharmaceutical companies.
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No claim for damages as a result of participation in clinical drug trials
A European Perspective #1 | GERMANY | The Frankfurt am Main Regional Court confirms: No reduction in the burden of proof (presumption of causality) pursuant to Section 84 (2) of the German Medicines Act (AMG) for IMP (not even by analogy) and no liability on the part of the sponsor in the event of (insufficient) risk information provided by the investigating physician.
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Promotional activities for medical devices may qualify as agency even without direct negotiation power
A European Perspective #1 | FRANCE | The French Supreme Court confirms a broad interpretation of commercial agent status. A key ruling increasing requalification risks and potential termination indemnity exposure for manufacturers and distributors.
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