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

The programme supports SMEs in clinically validating innovative medical-technology solutions under the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR). Its purpose is to help SMEs build the necessary clinical and regulatory expertise, accelerate the transfer of innovations into healthcare and reduce late-stage R&D investment risks.

Projects must address an unmet medical need and offer significant potential to improve patient care.

Funding Amount

Funding is provided as a non-repayable grant covering part of the eligible project costs.

• Module 1 – Conceptualisation and Planning: Up to 75% of eligible costs under the de minimis framework, with a maximum grant of €300,000 per project. The applicant must also comply with the €300,000 de minimis ceiling for a single undertaking over three years.
• Module 2a – Exploratory/Pilot Clinical Studies: Classified as industrial research and funded at a base rate of up to 50% of eligible costs.
• Module 2b – Confirmatory/Pivotal Clinical Studies: Classified as experimental development and funded at a base rate of up to 25% of eligible costs.

For Module 2, the funding rate may be increased by:

• 20 percentage points for small enterprises
• 10 percentage points for medium-sized enterprises
• Further permitted bonuses under the General Block Exemption Regulation

The maximum funding rate for industrial research or experimental development is 80% of eligible costs.

Innovation advisory and support services are generally funded at up to 50%. This may increase to 100% if the relevant conditions are met and the total support for these services does not exceed €220,000 per enterprise over three years.

No overall programme budget is specified.

Submission Deadlines

Project outlines are assessed on the following recurring dates:

• 15 January
• 15 May
• 15 September

The dates are not strict exclusion deadlines; however, outlines received after a cut-off may not be considered promptly in that assessment round.

Submission Conditions

Applications follow a two-stage procedure for both modules:

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

The project outline should not exceed ten A4 pages, excluding annexes, and must cover:

• Project subject and objectives
• Unmet healthcare need and care environment
• Innovation, preliminary work and relevant patents
• Market potential and competition
• Applicant’s expertise
• Work packages and timetable
• Estimated project costs
• Exploitation plan, including certification, commercialisation and reimbursement

Required evidence depends on the module and can include proof of the scientific and technical functional principle, a draft study protocol, clinical-development plan, study design, sample-size calculation and evidence of an ISO 13485-compliant quality-management system.

For Module 2, a favourable ethics-committee assessment and submission of the application for regulatory authorisation are required before the project begins. The necessary regulatory authorisation and conformity evidence must be available within the first 12 months for funding to continue.

Eligible Types of Businesses

Only small and medium-sized enterprises meeting the EU SME definition may apply.

The applicant must:

• Develop and conduct the project as an individual SME project
• Intend to introduce the resulting product into patient care
• Act as the manufacturer under the MDR or IVDR
• Demonstrate the relevant technical, clinical, regulatory and commercial capabilities
• Provide a credible certification, reimbursement and exploitation strategy

Research institutions, universities, hospitals and other organisations are not direct applicants under this call, but their services or expertise may be incorporated through subcontracting where appropriate.

Eligible Countries

Applicants must have a business establishment or branch in Germany when the grant is disbursed.

The funded results may be commercially exploited only in:

• Germany
• European Economic Area countries
• Switzerland

Target Technology Readiness Level

The programme targets technologies that have progressed beyond early research and are ready for clinical-development planning or clinical validation:

• Module 1: Scientifically and technically demonstrated functional principle; preparation for clinical investigation
• Module 2a: Exploratory or first-in-human clinical investigation
• Module 2b: Confirmatory or pivotal clinical investigation supporting regulatory approval