The Federal Ministry of Health (BMG) plans to establish AI real-world laboratories in healthcare as part of a package of measures to accelerate the transfer of innovative AI systems into care delivery. One of these projects aims to support institutions that develop AI (“AI Developers”) in identifying, addressing regulatory requirements early on and establishing correspondingly compliant development processes. This goal is primarily to be achieved by developing and publishing reference documentations (“blueprints”) for parts of the technical documentation required within the framework of a conformity assessment. The BMG plans to support AI developers, especially small and medium-sized enterprises (SMEs), in jointly developing such “blueprints” with relevant experts. A prerequisite for participation is that the resulting “blueprints” are fully published to create added value also for AI developers who are not involved. The “blueprints” developed within the framework of the project are intended as a whole to address various challenges that are each highly relevant for the market and currently complicate the placing on the market of innovative AI systems for healthcare provision.
This tender serves the implementation of pilot projects within the framework of the aforementioned initiative. The focus of the tender is on AI applications for healthcare in the broad sense, including (but not limited to) medical devices. For project implementation, selected parts of the technical documentation for the conformity assessment process of such an AI application are to be prepared and processed as reference documentation (“blueprint”).
LOT-0001
13200#00037#0004_Lot 1
Verification and Validation.
The subject of the tender is the provision of selected parts of the documentation usually required within the conformity assessment process in the sense of reference documentation. The documentation relates to an AI application for healthcare, which does not necessarily have to be a medical device. In addition to the reference documentation, further services related to the documentation preparation are to be provided (see section 1.2).
AI applications for the healthcare system within the meaning of this tender are products or systems defined as AI systems under the AI Regulation (AI-VO) or contain such a system. A (prospective) use in healthcare must be given.
The reference documentation and the statement provided by the contractor aim to facilitate and accelerate future conformity assessment processes and will accordingly be published by the BMG or institutions designated by the BMG for reuse by third parties.
Please refer to the tender documents for details.
LOT-0002
13200#00037#0004_Lot 2
Data Protection.
The subject of the tender is the provision of selected parts of the documentation usually required within the conformity assessment process in the sense of reference documentation. The documentation relates to an AI application for healthcare, which does not necessarily have to be a medical device. In addition to the reference documentation, further services related to the documentation preparation are to be provided (see section 1.2).
AI applications for the healthcare system within the meaning of this tender are products or systems defined as AI systems under the AI Regulation (AI-VO) or contain such a system. A (prospective) use in healthcare must be given.
The reference documentation and the statement provided by the contractor aim to facilitate and accelerate future conformity assessment processes and will accordingly be published by the BMG or institutions designated by the BMG for reuse by third parties.
Please refer to the tender documents for details.
LOT-0003
13200#00037#0004_Lot 3
Risk Management.
The subject of the tender is the provision of selected parts of the documentation usually required within the conformity assessment process in the sense of reference documentation. The documentation relates to an AI application for healthcare, which does not necessarily have to be a medical device. In addition to the reference documentation, further services related to the documentation preparation are to be provided (see section 1.2).
AI applications for the healthcare system within the meaning of this tender are products or systems defined as AI systems under the AI Regulation (AI-VO) or contain such a system. A (prospective) use in healthcare must be given.
The reference documentation and the statement provided by the contractor aim to facilitate and accelerate future conformity assessment processes and will accordingly be published by the BMG or institutions designated by the BMG for reuse by third parties.
Please refer to the tender documents for details.
LOT-0004
13200#00037#0004_Lot 4
Cybersecurity and Robustness.
The subject of the tender is the provision of selected parts of the documentation usually required within the conformity assessment process in the sense of reference documentation. The documentation relates to an AI application for healthcare, which does not necessarily have to be a medical device. In addition to the reference documentation, further services related to the documentation preparation are to be provided (see section 1.2).
AI applications for the healthcare system within the meaning of this tender are products or systems defined as AI systems under the AI Regulation (AI-VO) or contain such a system. A (prospective) use in healthcare must be given.
The reference documentation and the statement provided by the contractor aim to facilitate and accelerate future conformity assessment processes and will accordingly be published by the BMG or institutions designated by the BMG for reuse by third parties.
Please refer to the tender documents for details.
LOT-0005
13200#00037#0004_Lot 5
Dynamic AI.
The subject of the tender is the provision of selected parts of the documentation usually required within the conformity assessment process in the sense of reference documentation. The documentation relates to a dynamic AI application for healthcare, which does not necessarily have to be a medical device. In addition to the reference documentation, further services related to the documentation preparation are to be provided (see section 1.2).
Dynamic AI applications for the healthcare system within the meaning of this tender are products or systems defined as AI systems under the AI Regulation (AI-VO) or contain such a system and where it is also given that a change to the AI after market introduction/commissioning will occur or has already occurred. This change can be either due to retraining or fine-tuning or caused by a change in the data base (for example, changed information sources in RAG systems). AI systems that change autonomously after market introduction are excluded from this tender. A (prospective) use in healthcare must be given.
The reference documentation and the statement provided by the contractor aim to facilitate and accelerate future conformity assessment processes and will accordingly be published by the BMG or institutions designated by the BMG for reuse by third parties.
Please refer to the tender documents for details.
LOT-0006
13200#00037#0004_Lot 6
Third-Party AI.
The subject of the tender is the provision of selected parts of the documentation usually required within the conformity assessment process in the sense of reference documentation. The documentation relates to an AI application for healthcare, which does not necessarily have to be a medical device. In addition to the reference documentation, further services related to the documentation preparation are to be provided (see section 1.2).
AI applications for the healthcare system within the meaning of this tender are products or systems defined as AI systems under the AI Regulation (AI-VO) or contain such a system and that access and use AI models or AI services from third-party providers. A (prospective) use in healthcare must be given.
The reference documentation and the statement provided by the contractor aim to facilitate and accelerate future conformity assessment processes and will accordingly be published by the BMG or institutions designated by the BMG for reuse by third parties.
Please refer to the tender documents for details.
LOT-0007
13200#00037#0004_Lot 7
Post-Market Surveillance.
The contractor provides the BMG with selected parts of the necessary documentation for the conformity assessment of its AI application for the healthcare system. A list of all required documentation components can be found in Table 1 of Annex 1 of this service description. The documentation must generally be designed so that it could be used within an actual conformity assessment process and would, with high probability, contribute to a positive conformity assessment.
If documentation parts include areas of technical documentation within the meaning of the AI Regulation (AI-VO), the following applies: Although Art. 11 para. 1 AI-VO generally allows small and medium-sized enterprises (SMEs) to prepare the technical documentation according to Annex IV AI-VO in a simplified manner, such simplification is excluded for this tender regardless of whether the contractor is an SME or not. All documentation parts must therefore be fully prepared without exception.
Furthermore, it must be noted that the required documentation parts partly refer to the MDR. Documentation parts related to the MDR must also be prepared if the AI application is not a medical device.
If the AI application is not a high-risk AI system, or this is not clear, it must be assumed for the purposes of this tender that it is a high-risk AI application. Relevant documentation parts must still be fully prepared accordingly, and shortened documentation for non-high-risk AI systems is not permitted under this tender.
Please refer to the tender documents for details.