Software —

ArtemLEX™ – CE Certification

ARTEMLex™

AI-powered Machinery Certification Solution

ARTEMLex is an AI-powered industrial compliance solution designed to handle a multitude of industrial regulations with a single product and a single set of data.

Helping companies navigate the significant amount of compliance reports, technical documents, and certification paperwork required by regulations like the Machinery Directive (2006/42/EC, 2023/1230/EC).

The Challenge
Shift from Directive to Regulation

1 What Has Changed?

The new Regulation, fully mandatory from January 20, 2027, strengthens and clarifies old rules with updated conformity procedures, a new focus on AI and cybersecurity, and the introduction of "substantial modification" rules.

2 Who Is Affected?

This impacts manufacturers, importers, distributors, and any company that substantially modifies existing machinery for the EU market.

3 What Is the Scope?

The Regulation applies to a wide range of products, including machinery, interchangeable equipment, safety components, lifting accessories, and partly completed machinery.

Key Requirements of the Machinery Regulation

ARTEMLex™ handles the significant amount of compliance reports, technical documents, and certification paperwork required by regulations like the Machinery Directive. We leverage our in-house legal and technical expertise to ensure your machinery compliance is not only efficient but also accurate and up-to-date with legal requirements.

1

Regulation & Standard Mapping

We identify your specific compliance problems and provide a clear mapping of all relevant regulations and standards, ensuring your project is compliant from the start. Our fully qualified German lawyers and legal experts specialize in regulatory law and stay up-to-date with all legal requirements.

2

Create a Harmonized Product Data Profile

Our platform collects and harmonizes all product-specific data into a unified profile. This includes design drawings, operational manuals, lab test reports, and traceability data from your production systems (MES/SCADA/ERP).

3

AI-Powered Report Generation

Using our Legal AI Templates and a Retrieval-Augmented Generation (RAG) approach, our platform automatically generates all necessary documentation with a single click. This includes technical documentation, CE Conformity Declarations, and other compliance status reports, reducing legal costs and empowering your in-house experts.

4

Continuous Monitoring & Maintenance

Our system is designed for ongoing compliance. It provides an audit package and continuously monitors your data to ensure it remains aligned with legal requirements, helping you maintain a high level of data security and know-how protection.

Conformity Assessment Procedure

Determine the machine's risk category to follow the correct conformity procedure, with stricter third-party involvement for high-risk machinery.

Harmonization

We collect and harmonize multimodal product data, including drawings, manuals, lab tests, and CE declarations, into a unified product data profile.

Retrieval

Our system uses a legal AI agent to retrieve specific information from external knowledge sources for each regulation.

Generation

The platform then produces the final, regulation-ready documents based on the user's query and the harmonized data.

AI-powered 1-click report generation of all relevant documentation, including technical and CE documentation, audit packages, and compliance status reports. Our goal is to empower in-house compliance experts to cover multiple regulations and save on legal costs.

Customers & Partners

The ARTEMLex™ Advantage

Our core team's unique combination of law, industrial knowledge, and AI enables us to understand both the legal requirements and the real-world complexities of manufacturing processes. This specialized expertise allows us to create AI solutions that are not only legally sound but also deeply integrated with your operational reality.

Legal Expertise

Our team includes qualified German and English & Australian lawyers specializing in regulatory and EU emission law.

Engineering Experience

With over 40 years of engineering experience globally, we specialize in manufacturing processes fully compliant with EU standards and regulations.

Data Security

Prioritizing data security and know-how protection, adhering to the ISO 27001 standard. Your data is encrypted in storage and during transit, with access controlled through authentication and authorization.

Feel free to contact us!

Share your compliance challenges with us. Our team will help you explore how ARTEM can simplify monitoring, reporting, documentation, and certification under complex regulations.

Acquisition Profile

For detailed acquisition criteria, please see below or download our PDF guide

Investment Volume

Up to €100 million

Location Quality

A, B, C

Location Quality

Core Urban Areas
Positive Demographic Trends
Residential Neighborhoods
Mixed-Used Areas
Locations with Stable Socio-Economic Conditions

Property Condition

Requiring Renovation
No Full-Scale Redevelopment Required
Standard to high-quality assets
Mixed-Use Areas

Tenants

Combination of High and Low Tenancy Levels Considered
May Include Partially Vacant Properties

Other

Mixed-Use Portfolios

Investment Volume

Up to €50 million

Location Quality

A, B

Location Quality

Established Office Locations
Mixed-Use Areas

Property Condition

No Full-Scale Redevelopment Required
Redevelopment Considered Only in Case of Repurposing

Tenants

Includes Partially Vacant Properties
Long-Term Leases Preferred

Other

Properties with Development Potentials

Investment Volume

Up to €50 million

Location Quality

A, B

Location Quality

Established Office Locations
Mixed-Use Areas

Property Condition

No Full-Scale Redevelopment Required
Redevelopment Considered Only in Case of Repurposing

Tenants

Includes Partially Vacant Properties
Long-Term Leases Preferred

Other

Properties with Development Potentials

Investment Volume

Up to €50 million

Location Quality

A, B

Location Quality

Established Office Locations
Mixed-Use Areas

Property Condition

No Full-Scale Redevelopment Required
Redevelopment Considered Only in Case of Repurposing

Tenants

Includes Partially Vacant Properties
Long-Term Leases Preferred

Other

Properties with Development Potentials

Investment Volume

Up to €50 million

Location Quality

A, B

Location Quality

Established Office Locations
Mixed-Use Areas

Property Condition

No Full-Scale Redevelopment Required
Redevelopment Considered Only in Case of Repurposing

Tenants

Includes Partially Vacant Properties
Long-Term Leases Preferred

Other

Properties with Development Potentials

Software —

ArtemLEX™ – CE Certification

ARTEMLex™

AI-powered Machinery Certification Solution

The ChallengeShift from Directive to Regulation

1

What Has Changed?

2

Who Is Affected?

3

What Is the Scope?

Key Requirements of the Machinery Regulation

1

2

3

4

Conformity Assessment Procedure

Customers & Partners

The ARTEMLex™ Advantage

Legal Expertise

Engineering Experience

Data Security

Feel free to contact us!

Acquisition Profile

The Challenge
Shift from Directive to Regulation