Conformity, documentation
and safe deployment

1. Applicable legal framework. Intended purpose, supply boundary, finished or partly completed machinery, overlapping legislation and market-entry and commissioning dates.
2. Requirements. Relevant essential requirements, risk assessment and responsibility for meeting them.
3. Conformity assessment procedure. Select a permitted route and establish whether a notified body is required.
4. Documentation, tests and standards. Prepare and evaluate the evidence required by the chosen procedure; documentation and verification develop together.
5. Declaration of conformity. The responsible manufacturer issues it once compliance is established. Partly completed machinery requires a declaration of incorporation and assembly instructions.
6. CE marking. Affix it where applicable legislation requires it, only after all relevant conditions have been fulfilled.

A certificate under one directive or one standard does not automatically establish compliance with every law applicable to the actual product configuration. For each document, check the model, version, configuration, covered requirements and connection to the relevant declaration of conformity.

Machinery Directive 2006/42/EC uses the EC declaration of conformity; Regulation (EU) 2023/1230 uses the EU declaration of conformity. Partly completed machinery does not bear CE marking under machinery legislation, although another applicable law may require CE marking.

Primary sources: European Commission — CE · Manufacturer obligations · Directive 2006/42/EC · Regulation 2023/1230

• Application boundaries, tools, accessories and connections to machinery, the building and information systems.
• People movement, public access, shared space, human contact and reasonably foreseeable misuse.
• Protective measures, stopping, safe states during failures and authorisation to resume operation.
• Acceptance criteria, documented on-site verification, instructions, operators and maintenance.

Where work-equipment safety depends on installation conditions, Directive 2009/104/EC requires an initial inspection after installation and before first use, and inspection after assembly at a new location, under relevant national rules. We define the conditions of a controlled pilot and subsequent routine operation separately.

Primary sources: Directive 2009/104/EC, Article 5 · Machinery Directive · Machinery Regulation

The European Commission allows manufacturers of machinery placed on the market before 20 January 2027 to also state conformity with Regulation 2023/1230 where applicable. This does not remove the requirement to comply with Directive 2006/42/EC until then. Mentioning the future regulation alone therefore does not establish whether particular evidence is correct.

Primary sources: EC — Machinery

Additional regimes may apply by purpose, such as medical devices or explosive atmospheres. Overlaps and exclusions follow the actual product and supply arrangement.

Separate AI functions can fall under another regime, including specific Annex III categories. We also assess applicable transparency rules and prohibited practices. Performance optimisation or user assistance is not necessarily a safety component; whether its failure endangers health and safety also matters.

• Data map: what is captured, what stays local, what goes to the cloud and who can access it.
• Remote administration: permissions, network separation, intervention records, updates and incident responsibilities.
• Learning from demonstrations: collection purpose, permission to use data, retention and further supplier use.
• Operations: model and configuration versions, autonomy limits, oversight, failure responses and change assessment.

Primary sources: EC — AI Omnibus · AI Act, Article 2 · AI Act, Annex I · AI Act, Article 6 · EC — AI Act · EC — personal data protection

A new ISO or IEC edition is not automatically a harmonised European standard cited under the applicable legislation. Harmonised standards are voluntary and provide a presumption of conformity only for the requirements they cover, under their citation conditions. Other technical solutions need appropriate evidence. A standard, test report or voluntary certificate does not by itself replace compliance with legal requirements and the responsible manufacturer’s declaration.

Primary sources: EC — harmonised standards · EC — machinery standards · EC — assessment and documentation

Handover connects vendor evidence with the actual customer application. The customer receives a traceable view of conformity, missing evidence, responsibilities and verification needed before a change or release of a new version.

• A map of the exact model and unit, hardware/software/AI configuration, tooling and intended use.
• A record of first EU market placement and any commissioning date, legal framework and responsible parties; destination countries for EPR.
• An evidence/version register linking declarations, certificates and tests to their covered requirements and configuration.
• A plan for localising instructions and customer information with appropriate specialist review.
• Preparation for specialist verification, required testing and a notified body where the assessment route requires one.
• Acceptance criteria, integration evidence and change records for the actual deployment.

Service scope: ALTAMENTE provides the agreed preparation, integration and coordination. Responsibility for conformity and the relevant declaration belongs to the entity determined by law; the appropriate parties perform specialist testing and assessments under the selected procedure. Their involvement is defined before work begins.