AI-powered CE Marking

From weeks to hours

ArtemLEX handles the administrative burden of CE marking – so you can focus on what matters. No compromises on documentation quality, no delays.

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What ArtemLEX delivers for CE marking

Risk assessment

AI-assisted risk assessment in accordance with applicable EU directives and harmonised standards – documented and audit-ready.

Technical documentation

Generate technical documentation in line with applicable standards. AI-assisted – but strictly guided by the requirements of relevant directives, regulations and norms.

Standards & directives

Based on your product information, the system automatically identifies which laws and standards apply to your product – so nothing gets missed.

CE marking with ArtemLEX – in 4 steps

  1. 01

    Classify product

    Automatically determine applicable directives and standards.

  2. 02

    Assess risks

    Structured risk assessment in accordance with the Machinery Regulation or the Low Voltage Directive (LVD).

  3. 03

    Create documentation

    Generate technical files and the declaration of conformity.

  4. 04

    Affix CE marking

    Mark in a legally compliant way and archive the files.

Simplify CE compliance now

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✓ No minimum term · ✓ Ready to use instantly · ✓ GDPR-compliant

Frequently asked questions about CE marking

Answers to our clients' most frequent questions. Can't find your question? Get in touch with us directly.

What is CE marking and what does it stand for?
CE stands for Conformité Européenne and confirms that a product meets all relevant EU requirements. The marking is mandatory for numerous product categories and a prerequisite for placing them on the EU market.
Which products require CE marking?
Products subject to CE marking include machinery (Machinery Regulation 2023/1230), low-voltage equipment (Low Voltage Directive (LVD)), toys, medical devices, construction products, personal protective equipment and many other product groups. ArtemLEX automatically determines which directives apply to your product.
What is technical documentation and what must it contain?
The technical documentation demonstrates that a product meets the essential health and safety requirements. It includes a product description, risk assessment, applied standards, test reports and the EU declaration of conformity.
What changes with the new Machinery Regulation 2023/1230?
The new Machinery Regulation (EU) 2023/1230 replaces the previous Machinery Directive 2006/42/EC from January 2027. New elements include extended requirements for AI-enabled machinery, digital operating instructions and cybersecurity requirements.
Do I need a notified body for CE?
Not always. For many products the manufacturer can declare conformity themselves (self-certification). For high-risk products – such as certain medical devices or explosion-protected equipment – a notified body (e.g. TÜV, DEKRA) is mandatory. ArtemLEX shows you which route applies to your product.