#SFHS2609886VNotice of Project to Modify Registration Methods for Various Life Support Devices under Title I of the List Provided for in Article L. 165-1 of the Social Security Code
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This legislative notice announces a change in the registration criteria for life support devices on the reimbursable product list in France. Specifically, protective helmets will now be covered for both children and adults with disabilities. Manufacturers and distributors have a limited time to respond to this proposed modification.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- The label for protective helmets is expanded to include adults with disabilities.
- Manufacturers and distributors are notified of the change.
- There is a window for written observations or requests to be heard.
Obligations
What this law requires
Manufacturers and distributors must submit written observations regarding the modification of protective helmet registration criteria (code 1292424) within 20 days from the date of this notice
Manufacturers and distributors may request to be heard by the CNEDiMTS (Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé) within 8 days from the date of this notice
Written observations submitted by manufacturers and distributors must be copied and transmitted to DSS-SD1C@sante.gouv.fr and DGS-PP3@sante.gouv.fr
The registration criteria for protective helmets (code 1292424) must be modified to extend coverage from 'children with disabilities' to 'children and adults with disabilities'
The CNEDiMTS must render an opinion on the proposed modification within 20 days from the date of notice