Our Medical Devices team has developed two comprehensive guides to provide clarity for medical device and IVD companies.

EU Medical Device Regulation guides

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.

Request MDR guide    Request IDVR guide

Our experts


We are one of the few firms with specialist regulatory capabilities in the medical device arena across Europe. Our in-depth knowledge of regulations and ability to cut through complexity enable us to support ambitious medical device companies' expansion into the EU and UK. We offer comprehensive support that encompasses data protection, advertising, reputation management, product safety and a host of other closely interrelated disciplines that few firms can combine.
Patent Perspectives Quick Listens - Episode 5
Synapse June 2025

Two years of UPC patent litigation: key lessons for life sciences companies

by multiple authors

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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.

17 June 2025

by Yolandi Coetzee and Pauline Springorum

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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.

17 June 2025
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by Dr. Anja Lunze, LL.M. and Verena Bertram

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UK to maintain current exhaustion of rights regime

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by Louise Popple

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