The technical dossier is yours. Part of its parts come from your suppliers.
Optima Doc Compilation will focus on assembling the technical dossier for the machine, based on the documents from your suppliers. It is currently in development: we are not selling it today; we are discussing it via video, based on your case.
In development
30 minutes via video, free of charge, no commitment required.
Optima Doc Compilation is a software product developed by Optima AI. It will handle the assembly of the machine’s technical documentation, based on the documents provided by your suppliers. The documentation and its responsibility will remain with the manufacturer.
The problem · What the text says · The quasi-machine · On which he will bear · For whom · What he will not do · In the meantime · Your documents · Price · Frequently asked questions · In the same direction
Bringing them together with yours. The technical documentation of a machine does not only contain what your design office has written: when the machine incorporates quasi-machines, their incorporation declarations and assembly manuals are part of it (Annex IV, Part A, of Regulation (EU) 2023/1230). It is up to the manufacturer of the final machine to bring them together with the rest.
An incorporation declaration, an assembly instruction: they come from your suppliers, in their original form, at the time they are sent. You do not rewrite them. You put them together and attach them to your machine.
Machine description, risk assessment, drawings and diagrams, calculation and testing reports, copy of the instruction manual: they are generated at different times in the project, and not always in the same department.
It lasts at least ten years and is presented to the market surveillance authorities upon request. On that day, it must be complete and one must be able to find one’s way around it, even if those who created it have left.
Before placing a machine on the market, the manufacturer establishes its technical documentation, the content of which is set out in Annex IV, Part A, of Regulation (EU) 2023/1230 (Article 10, paragraph 2). The regulation applies from 20 January 2027. Until then, Directive 2006/42/EC refers to a «technical dossier» and sets out its content in its Annex VII, section A.
What Annex IV, Part A, requires as a minimum:
At least ten years after placing on the market or putting into service, at the disposal of market surveillance authorities (Article 10, paragraph 3). The directive shall be valid for at least ten years from the date of manufacture, or the last unit of a series.
At the request of an authority, the manufacturer shall provide it with the documents, in paper or digital form, in a language that it can easily understand (Article 10, paragraph 10). The regulation does not set any other language rule for the technical documentation.
Under the directive, failure to present the dossier after a reasoned request may suffice to call into question the conformity of the machine (Annex VII, section A, point 3). Under the directive, the dossier can still be reconstituted at the time of the request: it does not have to exist permanently in physical form or be located within the territory of the Union.
To go further:
What the instruction manual of a machine must contain ›
The instructions leaflet with the regulation (EU) 2023/1230 ›
The manufacturer of a quasi-machine draws up three documents: an EU incorporation declaration (Article 22 of Regulation (EU) 2023/1230, model in Annex V, Part B), an assembly instruction (Annex XI) and technical documentation (Annex IV, Part B). The declaration and the assembly instruction are then attached to the technical dossier of the machine incorporating the quasi-machine.
It indicates in particular the essential health and safety requirements applied and fulfilled, the commitment to transmit the information to the authorities, and the prohibition of putting the quasi-machine into service before the final machine has been declared compliant.
It can be digital: the manufacturer indicates how to access it, it is printable and remains online for at least ten years; a paper version is provided free of charge if requested at the time of purchase, within one month. It is written in a language easily understood by the integrator, determined by the Member State (Article 11, paragraph 7).
Annex IV, Part B: the machine’s components, adapted for the quasi-machine, including a copy of the assembly instructions. With the declaration of incorporation, it shall be kept for at least ten years after the placing on the market (Article 11, paragraph 3).
Under Directive 2006/42/EC, until January 19, 2027: declaration of incorporation in Annex II, Part 1, section B; assembly notice in Annex VI; relevant technical documentation in Annex VII, Part B. The notice and declaration accompany the quasi-machine until its incorporation, then become part of the technical dossier of the final machine (Article 13).
Optima Doc Compilation will focus on assembling the technical dossier for the machine, based on the documents from your suppliers. It is currently in development: its functionality is not finalized yet, and we are not describing any screens or functions that do not yet exist.
The question he will address: bringing together, in the technical documentation of a machine, documents from several suppliers.
Optima Doc Compilation will address the design offices that make up the technical dossier for a machine with documents received from their suppliers.
Your machine, or assembly, incorporates almost-machines purchased. Their incorporation declarations and assembly manuals are included in your technical file.
Your engineering firm designs the machine; part of its components, and the documents that accompany them, come from your suppliers.
The Optima Doc Compilation will focus on assembly. The technical documentation will remain the responsibility of the manufacturer.
We are not selling it today and we are not announcing a date.
In Optima Compliance, apart from testing tools, your documents are stored in France. They are never accessible to another client. They are not used to train an AI model.
The Optima Doc Compilation is not for sale today. The 30-minute exchange is used to discuss your case.
The exchange is free of charge.
30-minute exchangeIt is the set of documents that the manufacturer establishes before placing the machine on the market: description, risk assessment, drawings and diagrams, applied standards, reports of calculations and tests, copy of the instruction manual, among others. Regulation (EU) 2023/1230 calls it «technical documentation» and sets out its content in its Annex IV, Part A; Directive 2006/42/EC, in its Annex VII, Section A. It is kept and presented to the market surveillance authorities that request it.
The manual accompanies the machine: it is intended for those who install, use and maintain it. The technical documentation remains with the manufacturer: it compiles the parts required by Annex IV, Part A, of Regulation (EU) 2023/1230, including the manual, and is presented to the authorities that request it. Optima Doc Creation drafts the first draft of the manual; Optima Doc Compilation, in development, will focus on assembling the technical documentation.
At least ten years after the placing on the market or putting into service, according to Regulation (EU) 2023/1230 (Article 10, paragraph 3). Under Directive 2006/42/EC, at least ten years after the date of manufacture, or of the last unit of a series. For a quasi-machine, the technical documentation and the declaration of incorporation remain for at least ten years after the placing on the market (Article 11, paragraph 3).
Under Directive 2006/42/EC, in one or more official languages of the Community, the instructions manual in accordance with its own rules. Regulation (EU) 2023/1230 requires that documents be communicated to an authority that requests them in a language that it can easily understand (Article 10, paragraph 10). It does not set any other language rule for the technical documentation.
The manufacturer of the quasi-machine (Article 22 of Regulation (EU) 2023/1230, model in Annex V, Part B; under the directive, Annex II, Part 1, section B). It indicates in particular the essential requirements applied and fulfilled, and prohibits the placing into service before the final machine has been declared compliant. With the assembly manual, it then joins the technical dossier of the machine that incorporates the quasi-machine.
No. Under Directive 2006/42/EC, it does not have to exist permanently in physical form: it must be able to be reconstituted and presented upon request, and it does not have to be located within the territory of the Union (Annex VII, section A). Regulation (EU) 2023/1230 provides that the manufacturer must provide the documents in paper or digital form, upon a motivated request from an authority (Article 10, paragraph 10).
Under Directive 2006/42/EC, failure to present it following a reasoned request may suffice to cast doubt on the conformity of the machine (Annex VII, section A, point 3). Regulation (EU) 2023/1230 maintains the obligation to keep it available to market surveillance authorities for at least ten years (Article 10, paragraph 3).
Optima Doc Compilation is part of the Documentation axis of Optima Compliance. Two other agents are working on the instruction manual.
Pilot version, with support
He writes the first draft of the instructions based on the machine’s functional analysis and risk analysis.
Pilot version, with support
Is your quote already available? It evaluates it using 5 weighted criteria and sends you a PDF report. The trial tool, on the other hand, displays the priority differences in your quote on the screen.
To go further:
What the instruction manual of a machine must contain ›
The instructions leaflet with the regulation (EU) 2023/1230 ›
30 minutes via video, free of charge, no commitment required.
French French 
English
30-minute exchange
Free, no commitment. With our customer relations manager, via video conference, on the task, the file or the machine of your choice.
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