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A key working group at the European Commission has approved major changes to the current guideline on clinical evaluation of medical devices (MEDDEV 2.7/1, Rev 3), including stricter requirements for demonstrating equivalency between a device under evaluation and an approved product.
Read more: Stricter 'Equivalency' Requirements On The Cards For EU Device Clinical Evaluations
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The US Food and Drug Administration (FDA) has published a new guidance titled "Applying Human Factors and Usability Engineering to Medical Devices", available from here.
Read more: FDA issues new guidance on Usability and Human Factors Considerations