In its decision no. 2025-875 DC issued on Friday, the Constitutional Council ruled on the conformity with the Constitution of the provisions of Social Security Financing Act no. 2025-199 of February 28, 2025 (LFSS) for 2025. Published in the Journal officiel on the same day, the LFSS 2025 came into force on March 1st, 2025, unless otherwise provided.
In terms of healthcare products, most of the provisions are not immediately applicable. Indeed, many implementation measures are expected, making the entry into force of the LFSS a real headache.
In order to facilitate the operational implementation of the LFSS 2025 for companies, we publish a timeline of the main measures that concern medical devices (MDs) and acts (see also our timeline of measures concerning pharmaceutical products).
You will find:
- In table 1, measures relating to market access, namely:
- the strengthening of the conditions for the reimbursement of hearing aids
- the submission of an assessment report on reimbursement via the Referential of innovative non-nomenclature acts (RIHN)
- changes to the system whereby reimbursement of certain MDs, services and acts is subject to submission of a form drawn up by the prescriber
- the derogatory and urgency financing of alternative MDs for a MD that is out of stock
- the submission of the CEPS annual report to the French Parliament by September 30, year n+1
- the condition of reimbursement of certain digital MDs on the transmission of usage data, and the possibility of suspending reimbursement in the event of non-compliance with usage conditions
- the restriction of the scope of restoring to good condition of use to MDs acquired by patients for reuse
- In table 2, measures relating to the safeguard clause (CS MD), namely:
- removing VAT from the CS MD base
- setting the Z amount for 2025
Table 1: Measures relating to market access for MDs and acts
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 43 | Reimbursement of hearing aid devices and services subject tocompliance by the retail distributor issuing them with the conditions of use and installation stipulated by the French Public Health Code, and with the conditions of distribution stipulated at the time of their inclusion on the List of reimbursable Products and Services (LPP) | NO | Conseil d’Etat decree setting the deadline for verifying compliance with these conditionsDecree setting effective date (no later than September 1, 2025) |
| Art. 46 | Submission of the French government’s report to the French Parliament evaluating the reimbursement of innovative biology and anatomopathology acts under the RIHN | YES[1] | / |
| Art. 48[2] | Clarification on the possibility of making the reimbursement of a healthcare product and its associated services, an act or patient transport, when particularly costly for the health insurance or when there is a risk of misuse, subject to the patient’s presentation of a document drawn up by the prescriber[3] | NO[4] | Regulatory text specifying the conditions for verifying that the prescriber has previously consulted the shared medical file (DMP) or that the prescription complies with the reimbursable indications (viaa specific teleservice) Ministerial orders setting out the MDs, acts and services subject to the measure, and specifying the nature of the information to be provided |
| Art. 75 | Creation of a derogatory financing system for “alternative” MDs when the interruption or expected cessation of supply of a MD is likely to cause harm or presents a risk of serious harm to patients or public health[5] | NO | Conseil d’Etat decree defining the terms and conditions of this temporary derogatory reimbursement |
| Art. 78 | Submission of the CEPS annual report to the French Parliament by September 30, year n+1 | YES | / |
| Art. 79 | Possibility of making reimbursement of certain digital MDs conditional on transmission of usage data to the health insurance | NO | Conseil d’Etat decree setting conditions for transmission of data certifying compliance with conditions of use |
| Art. 79 | Suspension of reimbursement in the event of non-compliance with the conditions of use of the digital MD beyond a certain duration[6] | NO | Decree determining the length of time during which reimbursement may be extended |
| Art. 80 | Limitation of the scope of the obligation to return to good condition of use to MDs acquired by patients with a view to reuse | NO[7] | / |
Table 2: Measures relating to the CS MD
| Art. | Purpose of the measure | Immediate implementation | Implementing measures to be taken |
| Art. 29 | Removing VAT from the CS MD tax base | YES | / |
| Art. 29 | Setting the Z 2025 amount at €2.26 billion | YES | / |
GD Avocats advises and supports companies in their market access and regulatory strategies. Contact us by e-mail: contact@gd-associes.com
[1] The LFSS specifies that it must be submitted within 6 months of the promulgation of the LFSS.
[2] The Constitutional Council set out 2 interpretative reservations regarding this article: (i) it will be up to the prescriber to inform the patient in advance of the absence of reimbursement for this treatment if he does not present such a document to the professional called upon to carry out the prescription and (ii) in the absence of such a document or if the document indicates that these conditions have not been met, these provisions must be interpreted as requiring the prescriber, where he has prescribed treatment for the patient which should have given entitlement to reimbursement, to draw up or amend this document within a period of time appropriate to the patient’s state of health and without this resulting in additional costs for the patient.
[3] The LFSS stipulates that as a consequence of this new measure, article L. 162-19-1 of the French Social Security Code (amended by article 73 of the LFSS for 2024), which sets out the current procedure for ensuring the appropriateness of prescriptions, is repealed.
[4] The LFSS provides for an entry into force date of January 1st, 2026.
[5] A decree, issued on the proposal of the French National Agency for Medicines and Health Products Safety (ANSM), will determine the alternative MDs and their corresponding indications, as well as the derogatory conditions for their reimbursement by the health insurance.
[6] These conditions of use are determined by the LPP inclusion decree. In such cases, the French National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) gives its opinion on the conditions under which the data collected are taken into account.
[7] The application decree on the return to good condition of use has not yet been published.
