The implementation of the EU Medical Device Regulation (MDR) and the EU In-Vitro Diagnostic Regulation (IVDR) is fast approaching, arriving in May 2021 and May 2022 respectively. Medical device and IVD companies face considerable changes to the regulatory framework for their products and need to plan ahead to ensure that they are ready.
These regulations will have a far-reaching impact upon any business seeking to expand into the EU. However, the sheer complexity of the regulations and the volume of continuous new guidance in relation to them creates serious barriers to market entry.
Our Medical Devices team has developed two comprehensive guides to help address this. Each guide provides clarity for medical device and IVD companies who may find the sheer size and complexity of the regulations a substantial hurdle to their international expansion plans.
Latest medical devices news and insights
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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Life Sciences Legal Lens – Vol. 1
A European Perspective #1
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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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