03.09.2024
The BMBF has published a new funding guideline to support small and medium-sized enterprises (SMEs) in the clinical validation of innovative medical devices and in-vitro diagnostics (IVDs). The guideline aims to accelerate the innovation process in the medical technology sector and is consistently aligned with the EU Medical Device Regulation (MDR).
The focus is on medical devices from risk class IIa and in vitro diagnostics from class B. The funding guideline enables SMEs to carry out individual projects for the planning and implementation of clinical trials and clinical performance studies. These projects are intended to promote the validation and market readiness of innovative medical technology solutions and accelerate their transfer to patient care.
Funding is provided in two modules:
- Module 1 covers the conception and planning phase. Here, SMEs should build up relevant qualifications and carry out a potential analysis. The aim is to create a complete clinical development plan that includes the test design, test protocol, technical documentation and all approval requirements.
- Module 2 supports the implementation phase, i.e. the conduct of clinical trials. This module can already be started after a positive assessment by the ethics committee and an application to the higher federal authority (BOB). The final approval by the authority only has to be received within 12 months of the start of the project, which speeds up the start of the project.
A key innovation of the directive is that the modules can follow on seamlessly from one another. This reduces the time gaps between planning and conducting clinical trials, which should make the entire development process more efficient.
With this new measure, the BMBF aims to accelerate the innovation process in the medical technology sector in the long term and support SMEs in the introduction of innovative products.
The directive offers one of the few opportunities to receive funding for clinical trials of medical devices in Germany and addresses important regulatory hurdles in the context of the MDR and IVDR.