High Authority of Health – FRANCE (HAS)

Methodological specificities of clinical evaluation of a connected medical device (DMC).


The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) is the commission of the High Authority for Health (HAS) which evaluates in particular medical devices (MD) and other health products for reimbursement by the ‘Health Insurance. Its role is to give the health authorities an advisory opinion recommending or not the assumption of the MD (inscription on the list of products and benefits refundable or LPPR), to contribute to the determination of the conditions of their good use and their place in the therapeutic, diagnostic or prevention strategy. Where appropriate, it decides on the conditions to optimize the use of the technology in terms of user competence and the necessary environment.


Review of the report on the development of the guide on its specific clinical evaluation, with a view to its access to reimbursement.


As with any other category of MD, any connected medical device (DMC) eligible for LPPR may be the subject, on the initiative of the company operating it, of a request registration under the brand name. Such a request must be supported by data allowing to assess the interest of the product and its public health interest, supporting the argument of Expected Service (SA) and the Expected Service Improvement (ASA). Indeed, these criteria regulatory assessment are required by CNEDiMTS, regardless of the type of medical device.
However, the CGD’s may have particularities related in particular to their mode of action, their impact on patients, carers, professionals or the organization of care. Their clinical development must take into account these features.

The objective of this project, undertaken in 2018, is to identify any methodological specificities in the clinical evaluation of CMDs, in order to allow manufacturers who submit a file to CNEDiMTS to integrate them into their clinical development strategy and to prepare their support by national solidarity. These works are part of the program of work of the HAS.

A “Guide to the Clinical Evaluation Specificities of a Connected Medical Device (DMC)” in view of its access to reimbursement has been produced.


Advisory, Health, Regulatory

High Authority of Health France

Expert Advisor

Open File

March 2018

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