Disclaimer: This English translation is provided for informational purposes only. In the event of any discrepancy, inconsistency, or difference in interpretation between this translation and the original German version, the original German version shall prevail.

Overall Description

KMU-innovativ: Medical Technology supports high-risk, pre-competitive research and development by innovative SMEs. The programme aims to develop new medical devices, in-vitro diagnostics and digital medical-technology solutions that improve patient care and have credible commercial potential.

The programme forms part of Germany’s High-Tech Agenda and is intended to strengthen cooperation between SMEs, research institutions, clinical partners and other healthcare stakeholders.

Funding Amount

Two alternative funding frameworks are available:

• De Minimis Funding: Maximum grant of €300,000, subject to the applicable three-year de minimis ceiling. Funding rates can reach 80% of eligible costs for micro and small enterprises and 70% for medium-sized enterprises.
• General Block Exemption Regulation Funding: No programme-specific maximum grant per project is stated. Base funding rates are generally up to 50% for industrial research, 25% for experimental development and 50% for feasibility studies. SME and cooperation bonuses may increase the rate to a maximum of 80%.

Universities, university hospitals and non-commercial research institutions may receive up to 100% of eligible project expenditure. Universities and university hospitals may additionally receive a 20% project allowance.

At least 50% of the requested consortium funding, including applicable bonuses and overheads, must benefit the participating SMEs.

Submission Deadlines

Project outlines are assessed on the following recurring cut-off dates:

• 15 April
• 15 October

These dates are assessment cut-offs rather than strict exclusion deadlines. Outlines submitted after a cut-off will normally be considered in the subsequent assessment round.

Submission Conditions

The application procedure has two stages:

1. Submission of a project outline through easy-Online
2. Submission of a full formal application following a positive evaluation and invitation

The project outline must:

• Be submitted in German
• Normally not exceed ten A4 pages, excluding the cover sheet and any separate clinical-study plan
• Describe the healthcare need, objectives, scientific and technical approach, state of the art and innovation
• Present market potential, competition and relevant intellectual-property considerations
• Explain the partners’ roles, work plan, costs and financing
• Include a clear exploitation, regulatory, reimbursement and commercialisation strategy
• Include a separate study synopsis for every planned clinical study
• Address the relevant legal and ethical requirements

Active participation by users of the proposed medical or digital-health solution is mandatory. Collaborative projects also require a written consortium agreement.

Eligible Types of Businesses

Eligible applicants include:

• SMEs meeting the EU SME definition
• Medium-sized companies with up to 1,000 employees and annual turnover of no more than €100 million, including linked and partner enterprises
• Universities and university hospitals
• Non-university research institutions
• Clinical institutions
• Healthcare and nursing-care providers
• Other organisations making a substantiated contribution to the project

Large companies may participate but must generally finance their own activities.

The project coordinator should normally be an eligible SME or medium-sized company and the principal commercial exploiter of the results. Projects involving more than five partners must provide specific justification for the size of the consortium.

Eligible Countries

Funding is directed at applicants established in Germany. At the time funding is disbursed:

• Companies must have a business establishment or branch in Germany.
• Universities, research institutions and other non-commercial organisations must have an establishment in Germany.

Commercial exploitation of the project results must take place primarily in Germany, the European Economic Area or Switzerland.