Germany – Medical software package – Hilfestellung zu Konformitätsbewertung für KI-Innovationen (KI-Reallabore)

The Federal Ministry of Health (BMG) plans to establish AI real labs in the healthcare sector in the form of a package of measures to accelerate the transfer of innovative AI systems into care. One of these projects aims to support entities that develop AI ("AI developers") in identifying, addressing, and establishing compliant development processes for regulatory requirements at an early stage. This goal will be achieved primarily by developing and publishing reference documentation ("blueprints") for parts of the technical documentation required as part of a conformity assessment. The BMG plans to support AI developers, particularly small and medium-sized enterprises (SMEs), in creating such "blueprints" together with relevant experts. A prerequisite for participation is that the resulting "blueprints" will be published in full to create added value for non-participating AI developers as well. The "blueprints" developed as part of the project will address, in their entirety, different highly relevant market challenges that currently hinder the placing on the market of innovative AI systems for healthcare. The tender at hand serves to implement pilot projects within the aforementioned initiative. The focus of the tender is on AI applications for the healthcare sector in the broader 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 will be created and prepared as reference documentation ("blueprint").