Medical Devices In Vitro Diagnostics Combination Products

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.

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.