CE marking guides
Practical knowledge on CE marking, risk assessment under Machinery Directive 2006/42/EC and conformity assessment. From the Machinery Directive through the new Machinery Regulation to the EU AI Act: the CE process made simpler, explained clearly, and verified against the official legal texts on EUR-Lex.
CE marking from the ground up
What CE marking means for machinery, which law applies, how the risk assessment and the technical file are built and when a notified body comes in.
CE marking for machinery: step-by-step guide
What CE marking means, who needs it, the steps of the conformity assessment under Directive 2006/42/EC and the most common mistakes under the Machinery Directive.
When is CE marking mandatory?
Which products and machines need a CE mark, who is responsible and what happens if the marking is missing or wrong.
CE marking checklist: every step to tick off
The complete checklist for the conformity assessment: from directive classification and risk assessment to affixing the CE mark.
CE marking the EU-compliant way
The EU requirements in detail: conformity assessment procedures, documentation duties and the correct way to affix the CE marking.
Machinery Directive 2006/42/EC: the overview
Scope, essential health and safety requirements, Annex IV and the conformity assessment procedures of the Directive, explained compactly.
Harmonised standards for machinery: type A, B and C standards
The standards system behind the Machinery Directive and the Machinery Regulation: type A, B and C standards and the most important ones for CE marking.
Risk assessment under the Machinery Directive: the complete guide
Risk assessment per EN ISO 12100: the three-step method, risk matrix, life phases and typical pitfalls that make the CE process harder than it needs to be.
EU Declaration of Conformity: mandatory content and template
Drawing up the EU Declaration of Conformity for machinery correctly: conformity assessment under Annex V of the Machinery Regulation and the differences to Directive 2006/42/EC.
Technical file for machinery
What belongs in the technical file under Annex VII of the Machinery Directive, how long to keep it and how to structure it so that every revision stays traceable.
Annex IV machinery: list, procedures, notified body
Which machinery falls under Annex IV of the Machinery Directive, when a notified body is required and what changes with the Machinery Regulation in 2027.
Substantial modification of machinery: when the operator becomes the manufacturer
Rebuilds, higher output, a new control system: under the criteria of the German labour ministry (BMAS), a modification can trigger a new CE obligation. The assessment scheme step by step.
What does CE marking a machine cost?
Realistic cost blocks instead of flat rates: internal working time, purchasing standards, external consulting and when a notified body is added.
From the Machinery Directive to Regulation (EU) 2023/1230
On 20 January 2027 the Machinery Regulation replaces the Machinery Directive without a sell-off period for new machinery. What changes, where the references are, how the new cybersecurity rules fit in and how ready you are.
New Machinery Regulation 2027: all changes at a glance
The new Machinery Regulation (EU) 2023/1230 replaces Machinery Directive 2006/42/EC. What changes for risk assessment, conformity assessment and the EU AI Act.
Machinery Directive vs Machinery Regulation: side by side with all references
Machinery Directive 2006/42/EC and Machinery Regulation (EU) 2023/1230 compared directly: comparison table following the official correlation table, deadlines, Part A/Part B quick check and gap-analysis checklist as PDF.
The Cyber Resilience Act for machinery: obligations, deadlines and reporting
Regulation (EU) 2024/2847 covers machinery with a data connection. Reporting since 11 September 2026 even for machines already sold, full obligations from 11 December 2027: scope, classification, procedures, penalties.
Cybersecurity for machinery: Machinery Regulation, RED and CRA together
Protection against corruption under section 1.1.9, EN 18031 under the Radio Equipment Directive until 10 December 2027 and the CRA: timeline, protection goals, assessment methods and the interface inventory.
Machinery Regulation readiness check: are you ready for 2027?
Free self-assessment with 10 questions on Machinery Regulation (EU) 2023/1230: score, traffic-light rating and concrete action areas in around 3 minutes.
The CE-Copilot tools in detail
Each module covers one step in the CE marking process: from standards research through the risk assessment to the declaration of conformity. First explained, then shown how the tool takes work off your desk.
Risk assessment software
AI-assisted hazard analysis per EN ISO 12100, 2D risk matrix, three-step risk reduction.
Standards finder
Identify the applicable EU directives and harmonised type A/B/C standards from the machine description with AI, including Annex IV detection.
Standards checklist
2,300+ harmonised standards, ticked off per project, bilingual search and filters by directive, status and transition period.
Declaration of conformity software
Draw up the EU Declaration of Conformity under Annex II/V: multilingual export (DE/EN/FR/IT), signature and logo.
Technical documentation software
50-point checklist (54 under the Machinery Regulation) under Annex VII, file upload per item and status tracking for the complete technical file.
Functional safety
Define the required performance level (PLr) per EN ISO 13849-1, document the SISTEMA result and verify PL ≥ PLr.
Test reports
Acceptance testing filtered by machine profile and guided by standards, with measured values and a four-status system for auditable documentation.
Training records
Document inductions and instructions in a structured way, with training type, refresher date and digital signature.
Cyber Resilience Act software
Implement the CRA: classification based on the date of placing on the market, inventory, risk assessment, Annex I, Article 14 reporting deadlines, CRA report, declaration and instructions.
Operating instructions software
12 chapters per Annex I section 1.7.4 of the Machinery Directive: guided editor, pre-filling from project data, residual risks from the risk assessment, AI texts, PDF and Word.
Operating instructions in dialogue: three AI roles write, substantiate and check
An author writes visibly into the document, a curator keeps the fact sheet with references, a reviewer reports unsubstantiated statements. Real session with screenshots, interactive demo, limits and price.
Standards change tracker
Subscribe to standards and be notified automatically when they change or are withdrawn, so the presumption of conformity stays in view.
Choosing CE software
Honest comparisons with established CE software and a look at which workflow suits which type of manufacturer.
Safexpert alternative: CE software compared
CE-Copilot and Safexpert in an honest comparison: scope of functions, pricing model and which tool suits whom.
WEKA Manager CE alternative: CE software compared
WEKA Manager CE, Safexpert and CE-Copilot in a fair overview: delivery, contract model, AI support and prices.
CE software compared: what CE-Copilot does differently
AI in the core workflow, a pure web app without installation, cancel monthly and transparent prices: the category comparison with classic CE software.
CE software: what pays off for whom?
SMEs without a CE department, series machinery and product lines, special-purpose machinery or CE service providers: typical pain points and the right workflow per audience.
Selling machinery into the European Union from outside the EU
Written for manufacturers in the US, UK, Switzerland and Asia: the economic operators you need in the EU, the technical file, market surveillance and a realistic timeline to the first shipment.
Export machinery to Europe: the overview for non-EU manufacturers
The starting point: what placing machinery on the EU market requires from a manufacturer outside the Union, and where the detailed guides go deeper.
Exporting machinery to the EU without an EU entity
Why every machinery shipment needs an economic operator established in the EU (Regulation 2019/1020, Article 4), what authorised representatives and importers actually do, and the compliance checklist before your first shipment.
EU authorised representative for machinery: when you need one
The role, mandate and limits of an authorised representative under the Machinery Directive and the Machinery Regulation, and when an importer covers the obligation instead.
Technical file for machinery imported into the EU
What the technical file must contain, who has to be able to produce it for the authorities and how long it must be kept.
US machinery to the EU: OSHA/NFPA 79 vs EN 60204-1 and the Machinery Directive
Where US design practice and EU requirements diverge: electrical equipment, safeguarding, control systems and documentation.
EU market surveillance for machinery: what happens at the border and after
How customs and market surveillance authorities check machinery, what they ask for and what non-compliance costs.
CE marking timeline for exporters: from design to first shipment
A realistic schedule for the CE process from the first design review to the first shipment, including notified body lead times.
Run EU machinery compliance in-house, in English
This guide is written by the team behind CE-Copilot, a software platform covering the whole EU CE process for machinery: directive classification, a standards finder across 3,600+ standards with harmonisation status, risk assessment per EN ISO 12100, functional safety documentation, test reports, the technical file, operating instructions and the EU Declaration of Conformity with exports in English, German, French and Italian. The platform is available in English; the AI drafts, you review and sign off.