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After announcing the implementation of minor technical changes to the instructions for the required malfunction summary reporting format in alignment with the current version of Form FDA 3500A, the U.S. Food and Drug Administration (FDA) has finalized its 2022 draft guidance document, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. This resource outlines the principles ..

Procedures for the updates of the European Medical Device Nomenclature The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedba..