Grant

Funding of projects on the topic "Translating Medical Technology Solutions into Patient Care – Demonstrating Clinical Evidence Without Delay"

Grant for small and medium-sized enterprises for the clinical validation of innovative medical devices of risk classes IIa–III and in vitro diagnostics of classes B–D. Application procedure is two-stage via easy-Online.

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Grant criteria

Application level: Advanced
Region: Germany (nationwide)
Funding rate: up to 50%

Funding objective

Support for SMEs in research and development projects in the field of clinical validation to demonstrate the safety and performance of innovative medical devices and in vitro diagnostics and to transfer them into patient care.

Eligible expenses

  • Costs for clinical trials
  • Qualification costs within the company

Eligible to apply

  • Companies

Funding requirements

  • SMEs according to the EU definition with a branch or establishment in Germany
  • Relevant scientific and technical preliminary work with comprehensive preclinical data
  • Proof of basic safety and performance requirements (MDR/IVDR Annex I)
  • Development of an appropriate test design and demonstrable patent situation
  • Transfer of the medical technology procedure or product into healthcare

Documents required for application

  1. Project outline
  2. Formal funding application (easy-Online)

Description

The funding program “Translating Medical Technology Solutions into Patient Care – Demonstrating Clinical Evidence Without Delay” supports small and medium-sized enterprises (SMEs) nationwide in advancing medical devices of risk classes IIa–III and in vitro diagnostics of classes B–D, which have so far only been tested preclinically, to clinical validation. The focus is on demonstrating safety and functionality in order to rapidly integrate innovative technologies into routine care. Both the actual clinical trials and internal qualification measures necessary for successful implementation are funded. The grant rate amounts to up to 50% of eligible expenses, with the exact amount depending on the application relevance of the projects.

Eligible to participate are companies as defined by the EU SME definition with a registered office or branch in Germany, which can already provide comprehensive preclinical data and have developed a well-founded study design including the patent situation. The two-stage selection process begins with the submission of a project outline to VDI Technologiezentrum GmbH. Based on a positive evaluation, an invitation to submit a formal application via easy-Online is issued. The Federal Ministry of Research, Technology and Space acts as the funding agency and, through VDI Technologiezentrum GmbH, assumes technical supervision and administration. This measure efficiently advances the transformation of innovative medical technology procedures into patient care.

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