Medical Devices

The medical device industry is under constant pressure to innovate and yet remain price competitive. Protecting, defending and enforcing intellectual property, securing collaboration partners, obtaining market access and managing public procurement, advertising products and hedging producers against product liability issues, are just some of the challenges that we help our clients overcome.

With more and more products falling in scope of the EU Medical Device Regulation (MDR), our team provides practical advice on the full product lifecycle, from R&D and classification to marketing claims and inspections. Our lawyers are well versed with the technical requirements applying to digital health solutions, e-health, m-health and other software-driven innovations. Of note, as many of our clients develop diagnostic solutions and IVD medical devices, our team helps them navigate the new standards imposed by the EU IVD Medical Device Regulation (IVDR) ahead of the May 2022 deadline.

Local experts within the firm are actively involved with medical device trade bodies (such as the ABHI in the UK, beMedTech in Belgium, SNITEM in France, e.V.r in Germany, and MedTech Europe), so are ideally placed to assist with new challenges as they arise.

Our international team supports clients to guide them through local requirements relating to medical devices and IVDs. They also prepare them for new regulatory changes, some of which will have a significant impact on the medical device industry over the next few years, such as the MDR and IVDR applicable from May 2020 and May 2022 respectively.

In the medtech sphere, our international Healthcare and Life Sciences team has significant experience in advising companies on:

• Research and development agreements, clinical investigations, clinical evaluation plans and local requirements concerning experiments on the human person
• Qualification strategies, including borderline qualification between medical devices and medicinal products, biocidal products, food supplements and cosmetics respectively
• Classification issues, particularly in the area of digital and innovative devices
• Conformity assessment and interactions with notified bodies
• Market access and reimbursement
• Supply chain arrangements from supply of raw materials to importation and distribution of final products
• Agreements with economic operators, intra-group and with external stakeholders
• Public procurements/tenders
• Promotion, advertising and claims concerning medical devices
• Product liability considerations and litigation
• Vigilance and post-marketing requirements for all stakeholders
• Anti-counterfeiting strategies
• Compliance of interactions with healthcare professionals, healthcare organisations, patients and patient associations in local and cross-border settings
• Anti-corruption legislation and corporate crime issues
• Patent protection and enforcement
• International trade mark filing and prosecution services for branded devices