Health

#SFHS2610480AOrder of April 16, 2026, Changing the Operator for Hearing Implants and Bone-Integrated Prostheses of the Company PRODITION

🇫🇷France··Other·Low Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This law updates the list of reimbursable products and services in France, specifically for hearing implants and bone-integrated prostheses. It changes the listed operator from PRODITION to DEMANT, affecting the labeling and categorization of these medical devices. Companies involved in the distribution or manufacturing of these products will need to note this change for compliance and administrative purposes.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Operator for hearing implants and bone-integrated prostheses changed from PRODITION to DEMANT.
  • Labeling and categorization of certain medical devices updated.
  • Companies need to adapt their administrative records and compliance measures.

Obligations

What this law requires

high

Companies distributing or manufacturing hearing implants and bone-integrated prostheses must update their product labels and documentation to reflect the change from 'Société PRODITION France' to 'Société DEMANT Aides Auditives France'.

manufacturersdistributors
operational
high

Entities responsible for the reimbursement listings must ensure that the codes related to hearing implants and bone-integrated prostheses are accurately listed under 'Société DEMANT Aides Auditives France'.

healthcare reimbursement authorities
operational
medium

All references to 'PRODITION' in product listings must be replaced with 'DEMANT' in both short and long descriptions.

manufacturersdistributorshealthcare providers
operational
high

Companies must comply with the updated product classifications effective from the date the arrêté is published in the Journal officiel.

manufacturersdistributors
thirteenth day following the arrêté's publication
operational
medium

The updated arrêté will be published in the Journal officiel de la République française, and companies must monitor this publication to ensure compliance with the new requirements.

manufacturersdistributors
reporting

Affected Parties

Medical device manufacturersHealthcare providers

Tags

medical devices,healthcare regulation,compliance