Research Allowance for Medical Technology, Biotech & Pharma
In health research, the actual research is eligible – the approval-related steps are not. Eligible are new treatment and diagnostic methods, preclinical work and clinical phases 0 to IIIa; clinical evaluations for CE approval, Phase IIIb/IV and regulatory activities fall outside the scope. We draw the line in a way that holds up to review.
All free & non-binding – no upfront risk.
Context
The review guidelines (Ch. 2.4.3, pp. 16–18) frame health research as an often multidisciplinary field: patient care, pharma/medicines & vaccines, medical devices, in-vitro diagnostics and digital health applications. The critical dividing line runs between research and regulatory approval.
Which R&D activities in Medical Technology & Biotech are eligible?
- Development of new treatment, prevention or diagnostic methods
- Preclinical research as well as clinical trials in phases 0 to IIIa
- Selected Phase IV studies under certain conditions: PAES, PASS and off-label use studies
- Development of medical devices and in-vitro diagnostics – up to (but not including) the purely approval-related clinical evaluation or performance evaluation
Example: research allowance in Medical Technology & Biotech
For illustration only – not a real client case.
Assumption: Assume around €360,000 of eligible R&D staff costs per year for a qualifying Medical Technology & Biotech project.
Simplified example based on the eligible R&D staff costs (as of July 2026); excluding the overhead flat rate, contract research, owner work and the cap. Your actual funding depends on the individual case.
Typical non-eligible activities & reasons for rejection
This is exactly where many first applications fail. These points come from the BSFZ review guidelines:
- Clinical trials in Phase IIIb and – as a rule – Phase IV
- Clinical evaluation of Class I–IIb medical devices (part of the technical documentation, serving regulatory approval only)
- Performance evaluation of in-vitro diagnostics
- Regulatory/administrative approval activities and listing in the DiGA directory
- Purely clinical routine care and preventive care as well as advisory activities
- Non-interventional studies: observational studies, case-control, cohort and registry studies
Research language instead of development language
The BSFZ assesses by scientific criteria. An example from Medical Technology & Biotech:
“We brought our medical device to market readiness.”
“Knowledge gap: whether a novel measurement principle significantly increases diagnostic accuracy compared to the state of the art – validated preclinically against defined sensitivity and specificity thresholds.”
FAQ: research allowance for Medical Technology & Biotech
Which R&D activities in medtech/biotech are eligible?
Eligible are new treatment, prevention and diagnostic methods, preclinical research, clinical trials up to Phase IIIa, and the development of medical devices and IVDs up to (but not including) the purely approval-related evaluation.
Are clinical trials eligible?
Preclinical work and phases 0 to IIIa are generally eligible. Phase IIIb and – as a rule – Phase IV are not, because these produce documentation for regulatory approval. Exceptions under certain conditions: PAES, PASS and off-label use studies.
Is CE approval or the clinical evaluation eligible?
No. The clinical evaluation of Class I–IIb medical devices and the performance evaluation of IVDs serve regulatory approval and are part of the technical documentation – and are therefore not eligible.
Does listing in the DiGA directory count?
No. Regulatory and administrative approval activities, including listing in the DiGA directory, are explicitly not eligible.