On 24th of November, the French National Authority for Health (HAS) organized meeting with manufacturers of medical devices with aim to explain the evaluation principles of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in order to accelerate the access for useful innovations to patients.
Additionally, CNEDiMTS considered the inclusion of dimension with quality of life assessment. CNEDiMTS proposed to manufacturers to document this dimension based on validated measurement scales. Thus, CNEDiMTS resorts to the evaluation that will be performed by patients.
On occasion to this meeting, several new policy documents were published in relation to regulation process of medical devices:
- Connected medical devices: Guide for filing a file to the CNEDiMTS
- It is a new guide for medical connected devices
- Evaluation criteria for all medical devices are the same regardless the type of medical device. However, this guide aims to describe the expectations of CNEDiMTS regarding content of the file for submission of connected medical devices and provides a list of required documents
- Current guide does not consider following devices:
- Devices having no declared medical purpose
- Connected medical devices that are not for individual use
- Software intended for general use
- Software intended for lifestyle or well-being uses that do not constitute medical devices
- The guide for tools for assistance of prescription or dispensing, management software or administration of data (medical, financial, reimbursement).
- CNEDiMTS's principles for evaluation of medical devices for individual use for access to reimbursement
- This background paper aims to provide practical overview of principles of evaluation by CNEDiMTS. This document is mainly intended for manufacturers and for national specialized professional councils.
- Document is divided into 3 parts:
- Description of the regulatory framework for reimbursement of medical devices
- Evaluation of the SA/ASA assessment during a registration and renewals of registration
- Conditions of the evaluation (clinical investigation, criteria for evaluation, equivalence, comparators, etc.)
Additionally, other documents were updated:
- Medical device route in France
- Pre-filing appointment with HAS for a medical device
- Early meeting with HAS for a medical device regarding clinical development
- Innovation package: Procedure for drawing up decisions
See full information in French here.
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