AI Act Compliance Project

The project team should consist of at least representatives from Regulatory Affairs, Quality Management, Legal, Development / Production as well as Upper Management. The responsibilities and tasks of the project members and, if necessary, of external service providers are assigned. All other activities (e.g., time and milestone planning, resource planning, and risk management) are based on proven project management procedures.

Regarding the AI system of interest, the key provisions and definitions of the AI Act are identified and interpreted. The results are summarized in an internal guideline document.

Based on the intended purpose, it is determined whether the product is an AI system as defined in Art. 3(1) AI Act and whether it is a stand-alone product or the safety component of a product. Finally, according to Art. 6 AI Act the AI-system is assigned to one of the AI Act risk categories to be discussed with the responsible Notified Body.

The existing technical documentation and the established quality management system are subjected to a gap analysis based on the AI Act requirements (Art. 11 and 17 AI Act, respectively).

The identification of AI-specific standards, guidelines and best practices is crucial for the implementation of the new requirements.

The results of the gap analysis are translated into specific new processes or adjustments to existing processes regarding the quality management system. This can be done by integrating them into the established quality management system (Art. 17 (3) AI Act).

The existing technical documentation is also expanded to include AI system (Art. 11 (2) AI Act).

In some sections, the AI Act expressly requires a compliance-by-design approach (Art. 13-15 AI Act), i.e. the regulatory requirements should be considered at an early stage in the development of the AI system.

The new contents of the quality management system and the technical documentation are trained internally. Furthermore, adequate AI literacy according to Art. 4 AI Act is built up.

HR-KI need to have a positive conformity assessment before EU market access:

• HR-KI according to Art. 6 (1) AI Act shall undergo a conformity assessment procedure according to the respective sector legislation in Annex I AI Act (Art. 43 (3) AI Act).
• Providers of HR-KI according to Art. 6 (2) and Annex III No. 1 AI Act can choose between internal control (Annex VI AI Act) or external assessment by a Notified Body (Art. 43 (1) AI Act). In the case that no harmonized standards are available the procedure according to Annex VII applies.
• Providers of HR-KI according to Art. 6 (2) and Annex III No. 2-8 AI Act shall apply internal control according to Annex VI AI Act (Art. 43 (2) AI Act).

The structured dialog with the Notified Body on the AI-specific further development of quality management and technical documentation prepares the actual AI Act conformity assessment procedure.

In accordance with Art. 96 AI Act, the Commission draws up guidelines for the practical implementation of the AI Act and Art. 41 AI Act authorizes the Commission to define common specifications. AI Board and AI Office both support the AI Act application by publishing further guidance. Finally, the European standardization organizations are supposed to provide new standards to meet individual AI Act requirements by 2026. The regulatory development of the AI Act must therefore be continuously monitored.