HAS updates on evaluation of medical devices

The Haute Autorité de Santé (HAS) in France has published information on the evaluation of medical devices. An article concerned with connected medical devices states:

“Faced with the growth of connected medical devices, the HAS publishes a guide specifying the specifics of their clinical evaluation to the attention of industrialists who request their reimbursement. If the evaluation is based on the same criteria as for any other type of medical device, specificities related to their connected nature must be taken into account: speed of evolution of the technological solution, multiple interactions between patients, carers, caregivers and others medical devices or objects, integration of expert systems processing data (algorithms with or without artificial intelligence).”

Translated by Google Translate

To help CNEDiMTS achieve its goal of getting beneficial technologies to patients, HAS has issued guidance for connected medical devices. This project led to the development of 2 complementary documents:

  • “a didactic guide designed to help companies that manufacture or use DMCs to anticipate the clinical requirements required by CNEDiMTS to determine the interest of a DMC in order to be supported by national solidarity
  • “the development report of this guide integrating the analysis of the literature, the data of the other evaluation agencies (INaHTA network), the files of the DMCs 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 theme”

Translated by Google Translate

These documents are available here:

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Published on 22. February 2019 in News, News France