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Selling medical devices in European countries can be a lucrative opportunity for manufacturers and distributors, especially with rising demand for innovative healthcare solutions. However, navigating the regulatory landscape across Europe requires a strategic approach—particularly in countries like the Netherlands, which follows the EU Medical Device Regulation (EU MDR 2017/745). This guide provides step-by-step instructions to […]

Introduction As digital healthcare solutions evolve, Software as a Medical Device (SaMD) has become a crucial innovation in modern medicine. Whether it’s a diagnostic app, AI-based imaging software, or a remote monitoring tool, if you’re planning to launch SaMD in the European Union (EU)—particularly in the Netherlands—you need to ensure CE Marking compliance. In this