This article examines the applicability of the law for the producers of medical devices and IVDs, which NO Bring products based on artificial intelligence to the market.

Among other things, he answers the question if a manufacturer should take into consideration the artificial intelligence act if he uses chatgpt or develops an artificial intelligence system for his use that classifies customers’ feedback.

1. Relating framework

1.1 Scold / application area

The act to define its “scope” (application area) in article 2:

This regulation applies to

A) Supplierwho have put artificial intelligence systems on the market in the Union or operate or put artificial intelligence models on the market with a general purpose, regardless of that these suppliers are placed in the Union or in a third country;

B) Ai Systems operatorwhich are based in the Union or are in the Union;

The regulation also defines the term operator:

The applicability of the law to the suppliers therefore refers to suppliers (producers) and the operator.

1.2 High risk Aci systems

According to the products of article 6 that contain or are, which contain or are, which contain or are, which are at high risk

• they are a safety component or contain and therefore endanger the health and safety of people or ownership
• They are mentioned in Appendix III unless they constitute a significant risk.

Anhang III HERE:

• Biometric systems
• General and professional training systems that decide access to education or serve the evaluation of learning results or the level of education
• Systems that co -eterminate on the selection, attitude, promotions or cessation of employment relationships

1.3 periods of transition

Article 111:

(2) Without prejudice for the application of article 5 in accordance with article 113 paragraph 3 letter a, this ordinance applies to operators of high -risk ACI systems, with the exception of the systems mentioned in paragraph 1 of the current article, which were put on the market or put in operation before August 2, 2026, only if these systems were then changed significantly in their conception. In any case, the suppliers and operators of high -risk Aci systems, who must be used by the authorities, meet the measures necessary for the fulfillment of the requirements and obligations of this regulation until 2 August 2030.

2. Requirements

2.1 Requirements for competence

In article 4, the regulation also requires competence to operators:

Suppliers e operator From systems to measures to best guarantee staff and other people involved in the operation and the use of artificial intelligence systems have a sufficient level of competence AI, for which your technical knowledge, your experience, training and training and context in which the AI ​​systems must be used, as well as people or groups of people to whom AI systems must be used.

The regulation also defines the term “artificial intelligence competence”:

2.2 Requirements for high -risk ACI operators

AI-ACT (article 26) obliges high-risk ACI operators for the following:

• System determined by the manufacturer
• Guarantee the competence of users
• Monitor the system, also make human supervision
• Keep the trunks
• Report problems (producers, authorities) (see also article 73)

In addition, operators are obliged

• To create a fundamental rights on the follow-up assessment (article 27)
• Register (article 49) (this affects the products according to Appendix III: IA Education, HR)
• The people affected by the decision provide information (article 86) (this applies only to products in accordance with Appendix III)

2.3 Requirements for operators “Some artificial intelligence systems”

Article 50 determines the requirements for different types of systems to:

3. Answers

3.1 Extended everything -hiara

In the first approximation, producers who do not produce artificial intelligence systems and use it are not influenced by A-Acts, apart from the competence requirements.

For example, the act to do not regulate the use (!) Of LLMS à latgpt. Artificial intelligence can also be used as part of the QM processes, e.g. B. Automating or optimizing processes (e.g. chatbox for customer communication) or to verify the compliance of products or processes.

3.2 Exceptions of everything -clear

However, there are exceptions.

• This includes high -risk Aci systems, in particular systems in accordance with Appendix III. This should be in the case of systems of producers of medical devices in the context of human resources, in particular for (further) education and for staff decisions. It is irrelevant whether the manufacturer has developed these systems themselves or used by third parties.
• If the producers manage their medical devices or themselves, they also count as high -risk systems operators. An example would be a manufacturer who manages the server for a mobile medical app on which Ai algorithms and which is a medical device or part of one are performed.

3.3 Note medical devices

The requirements of the law on medical devices (e.g. MDR, IVDR, ISO 13485) apply regardless of this. For example, manufacturers should consider the requirements for validating the computer system if they use a system to as part of the QM processes.

Similar posts