A new guideline to clinical evaluation of connected medical devices in France

In mid-February 2019, the French High Authority for Health (HAS) has published the new guideline to clinical evaluation of connected medical devices in France.

The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) evaluates connected medical devices (CMDs) with multiple purposes of use. Their evaluations take part in the coverage decision-making process. Because of the technical characteristics of the CMDs, in particular, the rapidity of the evolution of these technological solutions and the multiple interactions that they allow between patients, caregivers, caregivers, and other medical devices or objects, the most appropriate methods for their clinical evaluation had to be designed.

This project that aimed to identify the methodological specificities of clinical evaluation of CMDs, with a view to their access to reimbursement was conducted in 2018. The assessment concerns medical devices evaluated by the CNEDIMTS, i.e., those for which the CMD can be the subject of individual funding by the Health Insurance, that is to say in addition to the existing acts or care packages. As a conclusion of this work, two documents have been developed:

• An instructive guide designed to help the manufacturers of the CMDs to anticipate the clinical requirements required by CNEDiMTS to determine the interest of the coverage of a CMD
• Methodological specificities of clinical evaluation of a connected medical device (analysis of the literature, the data of the other evaluation agencies, the files of the CMDs already evaluated by the CNEDiMTS, the diagrams of studies recorded on the databases clinical trials, the consultation of various stakeholders and the position of a multidisciplinary working group mobilized on this topic)

All details and documents can be found in French here, but the evaluation criteria of the CNEDiMTS for the reimbursement of a CMD are:

• The interest of CMD for the patient (clinical evidence) and for the public health (good outcomes in terms of mortality, morbidity, quality of life, response to a therapeutic need, etc.)
• Assessment of the expected service improvement (CNEDiMTS’ opinion on the improvement of the current situation (major (I), important (II), moderate (III), minor (IV), no improvement (V))

See more on how the CNEDiMTS assesses the medical devices in their document here.

See also more information on this topic that MTRC published about in December 2017 here.

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