French manufacturers, importers and distributors of high-risk artificial intelligence systems need to prepare for new compliance obligations. The deadlines of 2 December 2027 and 2 August 2028 apply to two separate categories of systems.
The EU regulation on artificial intelligence, known as the AI Act, sets out a CE marking procedure for systems classified as high-risk. For French companies that develop, sell or integrate AI solutions, including in robotic equipment, the first step is to determine the system’s regulatory category. That classification determines the assessment procedure, the documents to be produced and the responsibilities of each party.
AI Act CE marking deadlines: 2 December 2027 and 2 August 2028
The timeline set out by legal expert Thiébaut Devergranne in his analysis of 18 August 2026 distinguishes two categories of high-risk systems, in line with EU Regulation 2026/1744.
- 2 December 2027: the requirements apply to high-risk systems falling under Annex III, notably in recruitment, education, biometrics and certain essential services.
- 2 August 2028: the deadline set for high-risk AI systems built into regulated products falling under Annex I, notably certain industrial equipment and medical devices.
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Articles 40, 42 and 43 of the AI Act, which set out the conformity assessment mechanisms, have applied since 2 August 2026. The marking obligation itself, however, stems from Article 16, according to the deadlines specific to each category.
The CE marking specific to the AI Act concerns high-risk AI systems. It does not apply across the board to all artificial intelligence software or to every robot sold in the European Union.
Robots with AI may fall under the Machinery Regulation
For robot manufacturers and integrators in France, the distinction between the artificial intelligence system and the physical product is decisive.
A robot with an AI function that could be classified as high-risk under the rules applicable to machinery must be examined against the corresponding sector-specific rules.
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The Machinery Regulation is treated separately in the EU timeline. According to Thiébaut Devergranne’s analysis, the AI requirements are to be added to its Annex III through delegated acts no later than 2 August 2028.
This interplay is particularly relevant to manufacturers of smart machines and to companies that build AI functions into equipment intended for the European market. The CE marking that already applies to a machine and the requirements specific to its artificial intelligence must be examined together.
Self-assessment or notified body: which conformity assessment applies
Article 43 of the AI Act defines several ways of assessing conformity. Whether an external body is needed depends in particular on the classification and on the regulations applicable to the system.
For most stand-alone systems under points 2 to 8 of Annex III, the provider carries out an internal control in accordance with Annex VI. This procedure involves checking the quality management system, the technical documentation and the consistency between the declared procedures and how the system actually works.
Biometric systems under point 1 of Annex III follow specific rules. Internal control is possible when the relevant harmonised standards are applied. In the other situations provided for in Article 43, an assessment by a notified body is required.
For systems built into regulated products, the sector-specific procedure applicable to the product remains decisive. The assessment can therefore incorporate the AI Act requirements into a compliance process already provided for by EU legislation.
What the technical documentation must cover: risks, data and human oversight
The French manufacturers concerned must put together documentation that demonstrates their systems comply with EU requirements.
The obligations set out in Articles 9 to 17 include in particular:
- Documented risk management throughout the system’s life cycle.
- Governance of the data used for training, validation and testing.
- Technical documentation describing how the system works and its characteristics.
- Logging to ensure events can be traced.
- Information intended for professional users and deployers.
- Human oversight measures appropriate to the risks.
- Requirements for accuracy, robustness and cybersecurity.
- A quality management system governing development and modifications.
SMEs and certain mid-sized companies benefit from proportionality provisions covering the technical documentation and the quality management system.
For a robot manufacturer, this documentation must also make it possible to track changes to the AI system, particularly when an update alters its behaviour or performance.
EU declaration of conformity and registration before market launch
Once the conformity assessment has been completed, the provider draws up an EU declaration of conformity in accordance with Article 47.
This declaration identifies the system, its provider, the applicable regulations and the standards used. It commits the provider’s liability and must be updated whenever relevant changes are made.
Under Article 18 of the AI Act, the declaration and the technical documentation must be kept for ten years after the system is placed on the market or put into service.
Article 48 then provides for the CE marking to be affixed. It must be visible, legible and indelible. For systems supplied only in digital form, an accessible digital marking is allowed.
Systems covered by Article 49 must also be registered in the dedicated EU database before being placed on the market or put into service. Certain sensitive categories, notably in biometrics and law enforcement, are recorded in a non-public section of that database.
When a French distributor becomes legally responsible for an AI system
Article 25 of the AI Act calls for particular vigilance from French distributors, importers and integrators.
A company that sells a high-risk AI system under its own name or brand may be considered its provider within the meaning of the regulation. It then takes on the corresponding obligations.
This requalification also applies when an operator makes a substantial modification to a high-risk system, or changes the intended purpose of a system not originally classified as high-risk in a way that brings it into that category.
For a robot distributor, customising a piece of equipment or integrating new AI software must therefore be examined in light of its regulatory intended purpose.
Liability does not depend solely on who the original manufacturer is. A French company that substantially modifies a system may have to take charge of its new conformity assessment.
Contracts with manufacturers and suppliers should in particular set out the permitted uses, technical modifications and access to the documents needed for compliance.
Substantial modifications can require a new conformity assessment
Article 43 provides that a substantial modification to a high-risk AI system triggers a new conformity assessment procedure.
This provision concerns systems that may change after they are placed on the market, particularly those that incorporate machine learning models.
An exception exists for changes predetermined by the provider, described in the initial technical documentation and accompanied by an analysis of their impact on compliance.
Robot manufacturers can therefore include in their initial file the planned changes to their AI systems, how they will be retrained and the operating parameters concerned.
For systems assessed by a notified body under Annex VII, Article 44 sets a maximum certificate validity of four years for Annex III systems and five years for Annex I systems, with renewal possible after reassessment.
How French companies should prepare: classification and contracts
Thiébaut Devergranne recommends that organisations start by drawing up an inventory of their AI systems and documenting their classification before the end of 2026.
For each high-risk system, the company must identify the applicable assessment procedure, the relevant standards and the technical documents to be compiled.
The preparation planned for 2027 includes compiling the technical file, organising the EU declaration of conformity, preparing for registration in the EU database and revising contracts with suppliers and customers.
For French distributors and integrators, an internal register recording system versions, their classifications and the modifications made also makes it possible to track the obligations that apply to each piece of equipment sold or put into service.