Regulation of medicines and medical devices

The legal aspects of medicine regulation are considered essential to protect public health, promote innovation and ensure access to safe and effective medicines. Pharmaceutical companies must carefully follow and adapt to the many regulations and standards governing the quality, safety and efficacy of medicines on the one hand, while the legal aspects of the production, distribution and marketing of medicines must, on the other hand, adapt to the rapid developments in the pharmaceutical industry. Although biological medicinal products have become a key element in modern medicine, the legal regulation of this field is gradually adapting and upgrading in order to effectively capture the rapid advances in scientific and technological developments.

Two European regulations play a central role in the area of medical devices: the Medical Devices Regulation and the Regulation on In-Vitro Diagnostic Medical Devices. While the aforementioned regulations are directly applicable, they partly allow for an additional national legal framework. Manufacturers and distributors of medical devices must understand and comply with these regulations in order to provide effective and safe medical devices to patients and healthcare facilities. The remarkable development of medical devices with embedded electronic systems that can be programmed or software that is itself a device, e.g. digital healthcare apps, is one of the challenges for integration into the existing legislation on medical devices.

We offer our clients a specialized legal team experienced in pharmaceutical and medical device regulation with an understanding of the industry and its specifics, the various aspects of regulation, for example, in the areas of advertising of medicines and medical devices, authorizations for the manufacture and sale of medicinal products, marketing authorizations, regulatory data protection, the pricing of medicinal products, and the health insurance coverage of the costs of medicinal products and medical devices. At the same time, we offer our clients an interdisciplinary approach in various areas of law, such as contract law, competition law and intellectual property law, which facilitates fast and carefully tailored solutions for each client.