Clear Clinical Documentation for Approval

Clinical compliance documentation is often the most uncertain part of a medical device submission. Medical device clinical evaluation is usually the final validation step before completing the technical documentation to facilitate review by a (global) regulator.

For many medical devices, there are no strict requirements for the minimum level of clinical evidence, and the needed evidence can vary by regulatory jurisdiction. It is ultimately the manufacturer’s responsibility to evaluate and justify the appropriate level of clinical evidence required for clearance or approval.

In the United States, manufacturers can liaise with the FDA through the pre-submission process to collect informal feedback on their clinical evidence to be gathered. In the European Union, there are limited opportunities for direct interactions with regulators (e.g., structured dialogues), meaning manufacturers often need to define their clinical validation strategy without consulting a Notified Body.

A common approach is to assess the current clinical standard of care and regulatory State-of-the-Art (SOTA) based on relevant standards, regulations, and guidelines. This helps manufacturers understand the clinical and regulatory performance requirements for their medical devices. The process involves conducting in-depth, systematic literature research and determining the level of clinical data needed.

If necessary, manufacturers may conduct a clinical investigation per ISO 14155 to collect evidence, either prospectively or retrospectively. Clinical writing for medical devices plays a crucial role in compiling and presenting this data, and setting up the device labelling. Based on all gathered clinical evidence—from literature reviews to study data—and risk assessment conclusions, manufacturers must demonstrate that the benefits of the medical device outweigh the potential risks.