The introduction of the European Database on Medical Devices (EUDAMED) is a monumental shift in the regulatory landscape of the healthcare industry. It is a strategic move by the European Union (EU) to address historical challenges of data fragmentation and regulatory oversight, heralding a new era of transparency, safety, and innovation. EUDAMED is more than just a database; it is a digital backbone designed to provide a “living picture” of the medical device lifecycle, ultimately defining the future of how medical devices are developed, monitored, and used.
The medical device sector in Europe has long operated on a fragmented system, with data residing in disparate national databases and various formats. This made it difficult for authorities to get a complete view of the market, track devices efficiently, or respond to safety concerns quickly across the EU. EUDAMED’s primary mission is to solve this by creating a centralized, comprehensive electronic system. It’s a fundamental move from fragmentation to centralization
Read more in our latest point of view here: Unifying Healthcare Data to Empower the Future:
