top of page

Legal Services for EU Product Conformity Assessment

CE Compliance Digitally Structured

Digital Support for CE Conformity Assessment

A purpose-built digital tool for the legal structuring and transparent documentation of conformity assessments – serving as a basis for internal and external evaluation of CE compliance.

DIGITAL CONFORMITY TOOL

Digital tool for structured and traceable compliance reporting

The digital tool is integrated into existing conformity assessment workflows and applied at the final stage of the assessment process. It consolidates regulatory requirements, supporting evidence and documentation in a legally structured and traceable manner, based on the logic of a decision tree.

The resulting conformity report serves as a reliable basis for internal release decisions and external CE compliance review.

Reliable compliance documentation, for internal and external review

Legally structured

Structured consolidation of regulatory requirements, supporting evidence and documentation

Fully traceable

Structured consolidation of regulatory requirements, supporting evidence and documentation

Designed to fit into existing processes

Structured consolidation of regulatory requirements, supporting evidence and documentation

Scope and System Boundaries of the Digital Tool

The digital tool supports the structured documentation and consolidation of conformity assessments — both assessments conducted internally and assessments provided by suppliers.
It does not replace a conformity assessment; rather, it reflects an existing assessment in a traceable form aligned with the legal framework.

Function and Limitations of the Tool

Cmk

SPC

EN ISO/IEC 17000

ISO 9000 series

FMEA

ISO/TR 14121-2

EN 63000

IEC TR 62476

ISO 12100

TGN 37

FMEA

ISO/TR 14121-2

EN 63000

IEC TR 62476

ISO 12100

Cmk

SPC

EN ISO/IEC 17000

ISO 9000 series

TGN 37

Integration into Existing Processes

The integration of the digital tool is carried out with advisory support and presupposes a prior legal assessment of the existing conformity assessment processes.In the case of private label manufacturers, this assessment regularly also extends to supplier processes and their integration into existing qualification and approval procedures.

Organisational Integration and Requirements

Get in touch

In an initial consultation, we assess whether the existing conformity assessment framework supports the effective use of the digital tool.

Advisory on Regulatory Product Conformity

The digital tool forms part of my legal advisory approach to the legal structuring of conformity assessments.

I advise manufacturers and private label manufacturers on regulatory product requirements and CE compliance.

Legal Notice

The content of this website is for general information purposes only and does not constitute legal advice. The digital tool forms part of my advisory approach and does not, on its own, replace legal or technical review or imply any assumption of liability or guarantee of outcome.

SAL – Structured Assessment Logic
Regulation (EU) 2024/2847 - CRA

SAL Type V(b) – Specific Public Interest Framework – NLF-based Comprehensive Non-Safety Public Interest Framework with non-structural (partial) classification logic

Read more
Regulation (EU) 2023/2854 – Data Act

SAL Type X – Parameter-driven Regime – Non-NLF-based Parameter-driven Framework

Read more
Regulation (EU) 2016/425 - Personal Protective Equipment (PPE)

SAL Type II(a) – Safety Architecture Framework – NLF-based Comprehensive Safety Framework with classification logic

Read more
Directive 2014/29/EU – Simple Pressure Vessels Directive (SPVD)

SAL Type III - Safety Architecture Framework – NLF-based Risk-Specific Safety Framework

Read more
Regulation (EC) No 1935/2004 – Food Contact Materials (FCM)

SAL Type X – Parameter-driven Regime – Non-NLF-based Parameter-driven Framework

Read more
Directive 2000/14/EC — Outdoor Noise Directive (OND)

SAL Type XI – Parameter-driven Regime – Non-NLF-based Parameter-driven Framework with classification logic

Read more

© 2026 by Rechtsanwalt Dr. Matthias K Bauer

bottom of page