New BMBF funding guideline for “clinical validation of innovative medical technology solutions” in Germany
28 August 2024
Funding supports SMEs in developing and launching medical devices
On 29 July 2024, the German Federal Ministry of Education and Research (BMBF) published a new funding guideline in the Federal Gazette (read the guideline in German). Aimed at small and medium-sized enterprises (SMEs), the guideline is intended to help optimise patient care and bring innovative medical devices closing current and relevant market gaps onto the market more quickly despite economic risks. SMEs should develop skills for meeting the new regulatory requirements, in particular clinical investigations/performance studies in accordance with Article 62 et seq. EU MDR / Article 57 et seq. EU IVDR.
The funding consists of two modules – a conception and planning phase and an implementation phase. The focus is on clinical investigations combined with innovation consulting services, innovation support services, IP services, preclinical studies, and ISO 13485 QMS implementations.
Innovation consulting services include e.g. knowledge transfer with respect to the preparation of clinical evaluations or the application of standards and regulations related to quality management systems and the preparation of the technical documentation to meet the GSPR’s.
Innovation support services involve i.a. biocompatibility tests, database and literature searches, research into standards and regulations as well as QMS certifications.
These special fundings are provided in accordance with Article 28 of Regulation (EU) 651/2014, which may allow funding up to 100%.
Applications for funding, including project outlines, are requested to be submitted online. To benefit from funding, interested companies should act promptly.
If you have any further questions, our experts at SCC will be happy to assist you.
