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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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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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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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Händlerpflichten unter der Lupe: EuGH soll Umfang der Prüfpflichten klären
Guidance to manufacturers withdrawing a medical device from the EU market
Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.
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EU and medicines supply issues (part one): Current measures
Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.
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EU and medicines supply issues (part two): Proposals for future measures
In part two of our article on EU and medicine supply issues we explore the key proposals outlined in pharmaceutical reform and their impact on marketing authorisation holders across the region.
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