The Spanish Agency of Medicines and Medical Devices (AEMPS), in collaboration with the Ethics Committees for Research with Medicinal Products (CEIm), has published an important new memorandum. This document is a key milestone in the evaluation of clinical investigations involving medical devices and performance studies with in vitro diagnostic medical devices, as regulated by the MDR and IVDR frameworks.
The memorandum is designed to support a coherent, rigorous, and consistent application of the current regulatory requirements for all stakeholders. It also aims to clarify interpretative and procedural uncertainties, enhancing transparency and understanding in the application of these complex regulations.
This initiative marks a significant advancement in supporting high standards in clinical research, fostering innovation while prioritizing patient safety.
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Read the whole document here: https://bit.ly/3J3NTRA
