The main change is the two-stage evaluation of the dossiers, which is closer to the principles of the PHRC. The initial dossier includes a synopsis of the planned clinical trial, rather than the full protocol. This will be requested if the dossier is pre-selected. The experts who analyzed the file for pre-selection may make remarks or recommendations to be considered for finalizing the protocol.

The call for projects has been modified for this edition and only allows single carriers. The carrier must be the entity responsible for CE marking under regulations 2017/745 or 2017/746, and where applicable previous directives during the transition period. Other entities involved in the assessment must appear as subcontractors.
The aim is to emphasize the DM manufacturer's responsibility under the regulations and impose very clear leadership on the project.

Yes, a pharmaceutical company is eligible for funding if it bears responsibility for CE marking and is an entity under French law. The jury will assess the relevance of the funding to the project carried out by the company. The quality management system must explicitly include in the scope of certification the indication(s) targeted by the clinical trial.

Projects featuring French clinical centers will be given priority consideration, and clinical trials abroad will not be subsidized, except in exceptional cases. Projects must do their utmost to carry out clinical trials in France. In the case of international multicenter trials, only expenses incurred in France will be taken into account in the base of eligible expenses.

In certain rare cases, such as certain rare diseases for which no reference center exists in France, funding may be considered , provided that:

• The promoter is an entity under French law,
• The foreign partners appear as subcontractors.
• The data remains the property of the promoter, and is consolidated in France, in order to guarantee the centralization of added value on the territory;

The jury will particularly appreciate:

• The documented justification for choosing a center abroad;
• The proportion of funding for part of the trial in France compared with funding abroad.

No: the work associated with the request for assistance must not have begun prior to the submission of the request for assistance. For financing the French part of a study, see Point "Can clinical trials outside France be financed?"

Development must be finalized to evaluate a medical device, and data collection for learning or algorithmic optimization purposes is out of scope and ineligible on this call for projects. Other calls for projects are more suitable for these development phases (bpifrance i-nov in particular).

The 15% bonus is reserved for companies that will formally commit to a wide dissemination of results in accordance with the notification-exempt framework scheme SA.58995 on aid to R&D&I. Learn more.
In application of the above scheme, the project sponsor, when benefiting from a bonus on the applicable rate of aid, undertakes to disseminate the results of the funded study widely through conferences, publications, and open-access repositories of the acquired data; this is regardless of whether the said results are successful or not.
This bonus is used here to promote high-quality clinical trials by sharing results widely in the ecosystem. If results and data are kept confidential, the bonus will not be used.

These costs are eligible if they form part of the clinical and/or economic evaluation program for the project's medical device.

The device must already be CE marked or in progress. Specific support for trial design is provided via le diagnostic DM de bpifrance. Costs related to CE marking itself are not eligible. This call targets clinical and/or economic evaluation after CE marking.

A priori not, but in specific documented cases, bpifrance will determine whether these costs are eligible.

The aim of the call for projects is to evaluate the medical and/or economic benefits of a medical device, and quality and regulatory procedures must be in the final stages. If the CE marking certificate issued by a Notified Body is not obtained, several elements can come to attest to the state of progress thereof, as detailed in the "Objectives of the call for projects" section:

• Acknowledgement of receipt of class 1 DM declaration to ANSM
• FDA clearance issued by the FDA in the United States
• Report of CE marking audit by a notified body including no more than 2 major non-conformities
• ISO 13485 audit report by a notified body containing no more than 2 major non-conformities and less than 12 months old
• Complete ISO 13485 internal audit report by an auditor independent of the project owner containing no more than 2 major non-conformities and dating back less than 12 months

Even for Class I DM, ISO 13485 certification is generally recommended. If this is the case: an audit report from a notified body and acknowledgement of receipt of the ANSM declaration will be sufficient. If this is not the case, and the acknowledgement of receipt has not yet been sent by ANSM, forward the dossier filed to ANSM.

The project must comply with the directive or regulation applicable to it for the duration of the funded program.

The call is annual and may be modified at the margin, depending on the progress of the current call, but will remain very close.