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
Preliminary injunctions in the UPC – lessons learnt
Two years in, the UPC has become a key forum for patent enforcement, offering swift preliminary injunctions across many EU states. Courts assess both infringement and patent validity rigorously, requiring applicants to act quickly and prepare thoroughly.
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Two years of UPC patent litigation: key lessons for life sciences companies
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UPC litigation in life sciences: seven early takeaways for the pharma, biotech and medical devices sectors
The Unified Patent Court (UPC) has become a crucial forum for life sciences patent litigation. Early rulings show strict claim interpretation, careful review of European Patent Office oppositions, and limits on the Bolar exemption. The UPC has clarified infringement tests for second medical use claims and considers patient interests in injunctions. These developments emphasise precise patent strategy, regulatory alignment, and proactive risk management for pharma, biotech, and medical device sectors.
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The UPC going beyond its borders: how your company can profit from the latest case law
The UPC now allows life sciences companies to enforce European patents more efficiently across multiple countries through its long-arm jurisdiction. This lets patent holders sue distributors based in UPC member states in a single action, even if products are sold or made in non-UPC countries. Following key rulings the UPC can issue cross-border injunctions covering several national patent parts, while respecting jurisdiction limits on patent validity challenges.
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UK to maintain current exhaustion of rights regime
