It is a matter of course for classic products with a potential for danger that the EU makes certain specifications regarding the safety of these products. In future, this will also be applicable to AI products. The Commission proposal for the AI Act includes the provision that potentially risky artificial intelligence (AI) systems must also bear a CE mark. This means that the tried and tested approach of product safety law will also be applied to AI systems, the aim of which is on the one hand to support the free movement of goods in the internal market by setting uniform requirements, and on the other hand to set high safety standards. In future, it will be the individual responsibility of the providers, who must assess and ensure the conformity of their systems themselves. At the same time, this should give them the necessary freedom to create innovations and new technologies.
In the draft, the Commission follows a graduated approach based on possible threats to EU values and fundamental rights:
systems with unacceptable risk are prohibited;
systems with high risk are subject to stringent regulatory requirements;
low-risk systems are subject to special transparency requirements;
other systems are permitted - subject to compliance with general laws.
Certain systems will be inadmissible from the outset because in the view of the Commission, they are too dangerous for the protected legal interests. These include, among others, AI systems that manipulate human behaviour in order to circumvent the free will of users, systems that exploit the weakness or vulnerability of a group of people, as well as systems that enable the authorities to evaluate social behaviour (social scoring).
The Commission has placed special restrictions on AI systems that pose a high risk to the health and safety or fundamental rights of natural persons. These so-called high-risk AI systems can only be placed on the market in the EU if they meet certain requirements.
The idea that it depends on the intended purpose is not new and is already firmly anchored in product safety law. Nevertheless, there is criticism of the Commission’s approach, because it means that one and the same product can be “only” AI or also high-risk AI, depending on the individual case. The provider (but also the user) bears the risk of correct classification, and since the penalties for a violation are severe - including high fines and sales bans - the concerns are understandable.
Through the certification approach used by the Commission from the area of functional safety through product testing and CE marking, providers who wish to place a high-risk AI system on the market must subject it to a conformity assessment according to uniform EU standards and within the framework of an internal control and certify the “product”. This means that the control is in the hands of the providers themselves. The core element here is the conformity assessment procedure, for which the provider is basically responsible. The main objective of a conformity assessment procedure is to prove that the system placed on the market complies with the (especially qualitative) requirements of the AI Act. A distinction must be made between two procedures:
After successful conformity assessment, the high-risk AI systems are to be registered in an EU database managed by the Commission in order to increase transparency vis-à-vis the public and to strengthen supervision and ex-post monitoring by the competent authorities. Furthermore, the declaration of conformity must be drawn up by the provider. In order to make it clear to the outside world that the requirements are met, the provider must affix the familiar CE mark.
For low-risk systems, the AI Act provides for certain transparency obligations, which incidentally must also be complied with for high-risk AI systems:
In the latter case, there are exceptions if the technology is necessary for the exercise of freedom of expression and freedom of art and science, but at the same time, there are appropriate safeguards for the rights and freedoms of third parties. In all three cases, exceptions are provided for systems for the detection, prevention, investigation and prosecution of criminal offences.
Systems with minimal risk can be used largely without restrictions (within the scope of other law). The vast majority of AI systems will probably fall under this category
The declared aim of the Commission is that the CE standards run in parallel and complement each other, because products often fall within the scope of several CE standards at the same time. This approach is fully reflected in the interaction between the AI Act and the Machinery Directive (or in future Machinery Regulation). The requirements in the AI Act address the safety risks posed by AI systems that control safety functions in machinery, whereas certain specific requirements in the Machinery Directive will ensure that an AI system is integrated in a safe way into the whole machine so that the safety of the machine as a whole is not compromised. In order to define responsibilities, Art. 24 of the AI Act states that if a high-risk AI system for products covered by the CE standards in Annex II is placed on the market or put into service under the name of the product manufacturer together with the product manufactured in accordance with the AI Act, the manufacturer of the product shall assume responsibility for the conformity of the AI system and shall be subject to the same obligations in relation to the AI system as a supplier under the AI Act.
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