For many medical device manufacturers, EUDAMED used to sit somewhere near the end of the regulatory checklist. Important, but not always urgent. Now, that has changed. As of 28 May 2026, the first four EUDAMED modules became mandatory: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. The European Commission confirmed this following […]
Here is a scenario that plays out more often than anyone in this industry likes to admit. A founding team spends four years developing a device. They run the clinical study. They file the 510(k). They get cleared. They hire their first two sales reps, set up shop at a major conference, and start calling […]
The implementation of IEC 62366-1 usability engineering is essential for developing Software as a Medical Device (SaMD) and Digital Therapeutics (DTx). Systematic application of usability engineering principles enables these digital health products to fulfill stringent regulatory standards, significantly enhance patient safety, boost user engagement, and optimize therapeutic outcomes. A structured IEC 62366-1 approach ensures that […]
In 2024, the European Database on Medical Devices (EUDAMED) is set to undergo significant changes that will impact the registration and monitoring of medical devices within the European Union. Manufacturers, authorized representatives, and other stakeholders in the medical device industry must familiarize themselves with these changes and make the necessary preparations to comply with the […]
