Quarem Resources

After years of phased delays and voluntary participation, four core EUDAMED modules become mandatory under EU MDR and IVDR on May 28, 2026. For manufacturers, importers, and EU Authorized Representatives, this is a hard regulatory deadline, not a guideline. What's changing? The European Commission's EUDAMED database was designed to consolidate device identification, certification, and surveillance data across the EU single market. As of May 28, the following four modules move

For AI-enabled medical devices, three regulatory frameworks now apply simultaneously. Understanding what each requires, and where they overlap, is the starting point for any compliance strategy. If your organization develops or markets AI-enabled medical devices in the European Union, you are now operating under three overlapping regulatory frameworks: the Medical Devices Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746), the EU AI Act (Regulation (E

For companies developing medical device software (SaMD), regulatory success depends on more than just following a single standard. It requires the seamless integration of three distinct frameworks: ISO 13485 (Quality Management), IEC 62304 (Software Lifecycle), and ISO 14971 (Risk Management).