A new global standard for clinical evaluation is on the horizon: ISO/DIS 18969. The core message is straightforward: clinical evaluations should be seen as a process – a continuous, integrated and strategically governed process.
The core message is straightforward: clinical evaluations should be seen as a process – a continuous, integrated and strategically governed process.
Let’s break it down:
• Continuous process: clinical evaluation should start during initial design, it should evolve through development phases and continue at post-market phase of the device.
• Integrated process: clinical evaluation work should integrate in an organic way with design & development, risk analysis and post-market surveillance where inputs and outputs are not siloed across processes, but they rather flow in a circular way from one process to another informing each other.
• Strategic process: the sooner the clinical evaluation process starts, the better!
This will support early identification of realistic claims, indications, and benefit–risk profile. Importantly, this will inform clinical strategy, shifting it upstream to avoid late and costly closing of clinical gaps.
The standard recommends what to document but leaves it open for manufacturers to decide how to document the clinical evaluation, and for those of us working with the EU MDR framework, no additional burden is added.
Currently, the ISO/DIS 18969 is in draft format, so not final yet – but definitely one to watch! Stay tuned for updates.
