The clinical evaluation strategy is an essential step in any clinical evaluation. It is specific to each type of medical device and to each manufacturer.
This strategy must be defined right from the development stage of a medical device, as it can determine the feasibility of a project. Drawing up a “state of the art” report at the development stage of a device can help define this strategy, and in particular identify the elements to be evaluated during a clinical investigation prior to marketing. For example, for an implantable device, the literature is often rich in information that will help define the means of measuring claims:
- Clinical performance: fusion rate, recurrence rate, survival rate, angle measurement, rupture rate, etc.
- Clinical benefit: a reduction in pain using the VAS scale, an improvement in mobility and quality of life using the HHS scale, the MHQ questionnaire or the EuroQol; an improvement in function using the Crawford criteria, etc.
- Safety: with risks identified as being linked to the device or procedure.
It will also make it possible to assess the clinical evidence for the device under study, and to compare this evidence with current knowledge. This confrontation of data may give rise to unanswered questions, which will need to be covered by the Post-Market Clinical Follow-up (PMCF) activity.
The strategy will define the sources of potential clinical data to cover the claims:
- Clinical investigation(s) of the device concerned;
- Clinical investigation(s) or other studies cited in scientific publications of a device whose equivalence to the device concerned can be demonstrated;
- Reports in peer-reviewed scientific publications of any other clinical trials of the device concerned or of a device whose equivalence with the device concerned can be demonstrated;
- Clinically relevant information from post-marketing surveillance (PMS), in particular post-marketing clinical follow-up.
Like Directive 93/42/EC, Regulation 2017/745/EU allows the use of preclinical data, test bench results, performance tests, ergonomic tests when clinical data are not deemed relevant to assess the performance and safety of the medical device (paragraph 10, article 61). This means that certain devices will be able to rely on pre-clinical data to evaluate the device; these data will have to be confirmed during Post-Market Clinical Monitoring.
This strategy can be used in particular for software medical devices. At the algorithm validation stage, for example, depending on the software, the algorithm is often tested on pre-established databases of images, for example. This crucial stage in the development of the device can be carried over into the clinical evaluation, if claims and strategy allow.