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CE conformity consultancy

CE conformity consultancy

Products (e.g., machinery, devices, systems), which are made available in the Member States of the European Union, must adhere to the protection objectives under each applicable European directive. In this context, most products fall under a CE Directive requiring the implementation of a risk assessment, compliance with harmonised standards, and the issuing of a declaration of conformity. It is only at this point that the manufacturer is entitled to affix the required CE marking.

As a service provider, we advise and support our customers to ensure the lawful and standard-compliant CE marking of their products. Employees devoted to their support are fully trained and certified CE coordinators.

Our services concerning CE conformity

  • Classification of the product under applicable European directives
  • Search for relevant harmonised standards
  • Product analysis, risk analysis, hazard analysis incl. definition of necessary remedial measures before putting into service
  • Specifications for external and internal documentation
  • Coordination and implementation of necessary measurements
  • Preparation of the CE declaration (declaration of conformity, declaration of incorporation)
  • Compilation of external and internal technical documentation

CE conformity tool

CE conformity tool

The TÜV-certified Safexpert solution provides the following functions:

  • a standards manager, which is automatically and regularly updated
  • a tabular assessment of risks, structured according to risk class, risk location, and life cycle stage
  • a separate compilation of safety information for users
  • an interface to Sistema, the IFA program to validate the performance level of functional safety according to DIN EN ISO 13849-1 and DIN EN ISO 13849-2
  • checklists providing an overview of the remaining steps required