AI Machinery Regulation Documentation Generator

The EU Machinery Regulation (EU) 2023/1230 is the replacement for Directive 2006/42/EC, taking full effect on 20 January 2027. It requires manufacturers to compile comprehensive technical files covering general descriptions, drawings, risk assessments, harmonised standards applied, test results, and instructions for use.

The Regulation introduces three major documentation changes compared to the Directive. First, technical documentation may now be delivered in digital format, reducing paper-based compliance overhead. Second, manufacturers must include cybersecurity risk assessment documentation for machinery with digital elements under Article 6 and Annex III, Section 1.1.9. Third, any AI-based safety functions require documented validation including training data, algorithms, and validation methods.

According to EU market surveillance data, approximately 23% of machinery compliance failures stem from incomplete technical files. The Regulation's Annex IV carries forward all Directive Annex VII contents while adding enhanced structure requirements. Market surveillance authorities can request technical files at any time — manufacturers who cannot produce them face enforcement action including product withdrawal from all 27 EU member states.

The technical file must be available in at least one official EU language, and instructions must be in the language of every country where the machinery is placed on the market. From 20 January 2027, technical files referencing only Directive 2006/42/EC will no longer be accepted for newly placed machinery.

Essential health and safety requirements (EHSRs) are mandatory safety objectives defined in Annex I of the Directive and Annex III of the Regulation that all machinery placed on the EU market must satisfy. Every applicable EHSR must be explicitly addressed in the technical file — regulators check for complete coverage, not selective compliance.

Core EHSRs common to both instruments include integration of safety (machinery must function without risk during intended use and reasonably foreseeable misuse), control system safety per EN ISO 13849-1 performance levels or IEC 62061 SIL requirements, mechanical hazard protections through fixed, interlocking, and adjustable guards, and protections against electrical, thermal, noise, vibration, radiation, and hazardous substance risks.

The Regulation adds critical new EHSRs that affect an estimated 40% of machinery manufacturers. Section 1.1.9 introduces protection against corruption — machinery with digital elements must prevent hazardous situations from cybersecurity threats affecting safety functions. Section 1.2.1 requires control systems to account for foreseeable cybersecurity threats. Autonomous and semi-autonomous machinery must include provisions for safe human-machine interaction, and AI-based safety functions require documented validation across foreseeable operating conditions.

From 2027, technical files that omit cybersecurity and digital protection EHSRs for connected machinery will be deemed non-compliant, potentially blocking market access across the entire EU.

A machinery risk assessment under EN ISO 12100:2010 follows a structured four-stage process: determine machinery limits, identify hazards across the full lifecycle, estimate and evaluate risk, then apply the three-step risk reduction method. This standard remains the foundational harmonised standard under both the Directive and the incoming Regulation.

The process begins with defining machinery limits — intended use, space limits, time limits, and reasonably foreseeable misuse. Hazard identification covers the complete lifecycle from transport and installation through commissioning, use, maintenance, and decommissioning. Risk estimation combines severity of harm with probability of occurrence, factoring in exposure frequency, hazardous event probability, and possibility of avoidance.

The three-step risk reduction method is mandatory and hierarchical. Step 1 requires inherently safe design measures — eliminating hazards through geometry, materials, or physical principles. Step 2 applies safeguarding measures including guards per EN 953 and protective devices per EN ISO 13855. Step 3 communicates residual risks through instructions, warnings, and training. Studies of Notified Body audit findings show that 31% of rejected risk assessments skip directly to Step 3 warnings without documenting why Steps 1 and 2 were insufficient.

Under Regulation (EU) 2023/1230, the risk scope expands to include cybersecurity threats where digital elements can affect safety functions, risks from AI components including training data bias and adversarial inputs, and risks from autonomous operation including human-machine collaboration and emergency intervention. Auditors expect documented evidence that the three-step hierarchy was applied iteratively.

Harmonised standards listed in the Official Journal of the EU create a legal presumption of conformity with the specific EHSRs they cover. Applying the correct harmonised standards is the most efficient route to demonstrating machinery compliance — EHSRs not covered by any standard require significantly more direct risk assessment evidence.

The key harmonised standards for machinery include EN ISO 12100:2010 for general safety principles and risk assessment, EN ISO 13849-1:2023 for safety-related control system design with performance levels PL a through PL e, EN 60204-1:2018 for electrical equipment safety, and EN ISO 13857:2019 for safety distances. Currently over 750 harmonised standards are listed under the Machinery Directive, covering approximately 85% of common machinery safety requirements.

Type-C standards define safety requirements for specific machine categories and take precedence over Type-A and Type-B standards where they differ. When a Type-C standard exists for your machinery, its requirements must be applied before falling back to general standards. Deviations from Type-C standards require documented justification demonstrating equivalent or higher safety levels.

New harmonised standards are anticipated for the Regulation's cybersecurity and AI requirements. CEN/CENELEC working groups are developing standards for AI-based safety function validation and cybersecurity of machinery with digital elements. The technical file must map every applied standard to specific EHSRs it covers. During the transition period, manufacturers should prepare for updated standard references when switching from Directive to Regulation compliance.

The EU Declaration of Conformity is the manufacturer's legally binding statement that machinery meets all applicable requirements. Under the Directive it follows Annex II format; under the Regulation it follows Annex V. An incomplete or incorrect Declaration renders the CE marking invalid and can result in market prohibition across all 27 EU member states.

The Declaration must include: business name and full address of the manufacturer and any authorized representative, description and identification of the machinery including generic denomination, function, model, type, serial number, and commercial name, an explicit statement of conformity with the applicable legislation, references to all harmonised standards applied, and the Notified Body identification number where applicable. It must be signed by an authorized person with place and date recorded.

From 20 January 2027, declarations must reference Regulation (EU) 2023/1230 instead of Directive 2006/42/EC. Where cybersecurity provisions apply, the declaration must confirm conformity with Section 1.1.9 of Annex III. The Regulation expands the list of high-risk machinery categories in its Annex I (replacing Directive Annex IV), with an estimated 15% more machinery types now requiring third-party conformity assessment.

CE marking must be affixed visibly, legibly, and indelibly to the machinery and cannot be placed until the Declaration is complete. High-risk categories — including woodworking machines, presses, injection moulding machines, and certain lifting equipment — require Notified Body involvement via EU type-examination or full quality assurance before the Declaration can be issued.

Instructions for use are a mandatory deliverable under Annex I, Section 1.7.4 and must accompany every machine placed on the EU market. They are typically the largest single document in a machinery technical file, often comprising 30-40% of total documentation volume for complex industrial machinery.

Required content includes: manufacturer identification and full address, machinery designation matching the nameplate, installation and commissioning instructions covering foundations, mountings, vibration isolation and assembly conditions, operation instructions for all modes (automatic, manual, setup, maintenance), maintenance procedures including inspection frequency, spare parts, and lockout/tagout procedures, and transport and handling information including mass, centre of gravity, lifting points, and storage conditions.

Safety information requirements are extensive. Instructions must describe all residual risks remaining after design and safeguarding measures, specify required PPE for operators and maintenance personnel, warn of foreseeable misuse based on experience with similar machinery, define training requirements and operator qualification levels, include all necessary diagrams and photographs, and provide noise and vibration emission values. Missing noise or vibration data violates both the Machinery Directive and applicable noise directives, carrying separate enforcement actions.

Language requirements are strict — instructions must be in the official language of every EU Member State where the machinery is sold. The Original Instructions must be clearly identified, with all other versions marked as 'Translation of the Original Instructions.' Under the Regulation, digital delivery is permitted but Member States may require paper copies on request. According to enforcement data, approximately 18% of market surveillance actions relate to missing or inadequate instructions for use.

Partly completed machinery — equipment that cannot function independently and is intended to be incorporated into other machinery — requires a Declaration of Incorporation instead of a Declaration of Conformity. This documentation is critical because the final assembler cannot complete their own conformity assessment without it.

Under Directive 2006/42/EC, the Declaration of Incorporation (Annex II Part B) must state which EHSRs from Annex I have been applied and fulfilled. It must include a statement that the partly completed machinery cannot be put into service until the final machinery is declared in conformity with the Directive. Assembly instructions per Annex VI must describe conditions for correct incorporation so the final machinery does not compromise health and safety. Industry surveys indicate that 26% of final assembly conformity delays trace back to incomplete or incorrect Declarations of Incorporation from component suppliers.

The Regulation carries forward all Declaration of Incorporation requirements with updated legislative references. A significant addition is that assembly instructions must now cover cybersecurity integration requirements where the partly completed machinery includes digital elements. Documentation must clearly identify which EHSRs are fulfilled by the partly completed machinery manufacturer and which remain the responsibility of the final assembler.

Incomplete EHSR coverage documentation creates dangerous ambiguity about safety responsibility. This leads to enforcement gaps where neither the component supplier nor the final assembler has fully documented hazard mitigation — a situation that market surveillance authorities increasingly flag during inspections.

The correct conformity assessment route depends on whether your machinery falls into a high-risk category. Selecting the wrong procedure — particularly using internal checks for high-risk machinery — invalidates both the CE marking and Declaration of Conformity, blocking EU market access entirely.

Under Directive 2006/42/EC, non-Annex IV machinery uses internal checks where the manufacturer compiles the technical file and draws up the Declaration without Notified Body involvement. Annex IV machinery (high-risk categories) has three routes: internal checks if all relevant harmonised standards cover all applicable EHSRs, EC type-examination where a Notified Body examines a representative sample, or a full quality assurance system approved by a Notified Body. Approximately 12% of machinery types currently fall into Annex IV high-risk categories.

Regulation (EU) 2023/1230 restructures the assessment routes using EU Decision 768/2008 modules. Non-high-risk machinery uses internal production control. High-risk machinery (Annex I of the Regulation, replacing Directive Annex IV) can use EU type-examination (Module B) combined with conformity to type (Module C) or quality assurance (Module D/E), or full quality assurance (Module H) where the Notified Body approves and monitors the entire quality system.

Critically, the Regulation expands the list of high-risk machinery categories. Manufacturers must verify whether their machinery type has moved between risk classifications in the transition. A machine that only required internal checks under the Directive may now require Notified Body involvement under the Regulation — a change that affects production timelines and costs.

The transition follows a hard cutover with no grace period: Directive 2006/42/EC is fully repealed on 20 January 2027, and all machinery first placed on the EU market from that date must comply with Regulation (EU) 2023/1230. There is no parallel compliance period after the cutover date.

Key dates are: 29 June 2023 when the Regulation was published in the Official Journal, the period until 19 January 2027 where the Directive remains in force and manufacturers may place machinery on the market under it, and 20 January 2027 when the Regulation applies in full. Machinery placed on the market before 20 January 2027 under the Directive remains lawfully on the market — no retrospective documentation update is required.

Industry analysis suggests that as of early 2026, approximately 35% of affected manufacturers have begun their transition planning. The required transition actions include: gap analysis between current Directive-compliant technical files and Regulation requirements, particularly cybersecurity provisions under Section 1.1.9, updating risk assessments to include cybersecurity hazards for machinery with digital elements, preparing updated Declaration of Conformity templates referencing the Regulation, and reviewing whether your machinery has changed risk classification between Directive Annex IV and Regulation Annex I.

The most significant risk is for machinery whose design began under the Directive but will first be placed on the market after 20 January 2027 — these must have full Regulation-compliant documentation regardless of when design started. Manufacturers targeting Q1 2027 product launches should complete documentation transitions by Q3 2026 to allow for Notified Body review cycles where applicable.