Expertise.
Labeling & IFU creation.
We work with you to develop regulatory compliant labels and instructions for use - adapted to MDR, IVDR and target markets.
Compliant?
Do your labels and instructions meet all regulatory requirements according to MDR or IVDR?
Clear?
Are the content, symbols and format prepared in such a way that they are internationally understandable and conform to standards?
Integrated?
Are labeling, UDI, GSPR and technical documentation properly linked in your company?
Structured labeling for safe product approval.
The requirements for labels and instructions for use are high - we ensure clarity, structure and compliance.
The MDR and IVDR require complete, comprehensible and target group-oriented product labeling. At the same time, the UDI, language, list of symbols, intended use, safety information and product handling must be presented correctly and in a coordinated manner - both within the IFU and on the label itself.
We support you in the creation and review of labels and Instructions for Use (IFU), including translation into the required EU languages, GSPR chapter assignment and consistency checks with the technical documentation. We also provide support with symbol-based representation and integration into packaging, software or digital IFUs.
Whether for Class I products or complex systems - we bring structure to your labeling and ensure regulatory compliance.
We create regulatory-approved labels and IFUs - comprehensible, consistent and market-driven.
Clear processes for compliant product labeling.
Our product labeling services - clearly structured and fully integrated.
Label design & symbolism.
- Testing and creation of labels according to MDR/IVDR
- Use of standardized symbols (e.g. ISO 15223-1, ISO 20417)
- UDI integration, language, warnings, manufacturer data
Creation & testing of IFUs.
- Structuring, translation and maintenance of instructions for use
- Coordination with technical documentation and GSPR
- Creation as a print or digital solution incl. access tracking
Process consulting & documentation.
- Establishment of regulated processes for release, versioning and responsibility
- Creation of SOPs, templates and test checklists
- System integration in PLM or QMS
Labeling in practice - how companies successfully implement labeling & IFUs.
Our projects show how manufacturers have implemented their labeling practices in a regulatory clean, linguistically precise and procedurally stable manner - whether print, digital or system-integrated.
Labeling check for an existing class IIa product
Creation of digital IFU with language selection for IVD product
Introduction of a labeling process with SOP and PLM connection
Challenge.
A manufacturer wanted to have existing labels and IFUs checked for MDR conformity.Measures.
- GSPR comparison with the relevant labeling & safety requirements
- Review of symbolism, language, purpose & UDI integration
- Creation of a checklist for adjustments to the packaging and labeling system
Results.
- Corrections for CE marking, warnings and manufacturer information
- Improved user-friendliness of the IFU
- Proof of conformity documented for notified body
Success.
Avoidance of non-conformities and safe passage through the audit process.Labeling in practice - how companies successfully implement labeling & IFUs.
Our service for compliant labeling and tested instructions for use.
We support you in the creation, testing and implementation of labels and IFUs - linguistically precise, technically integrated and regulatory compliant.
We check existing labels and IFUs for conformity with MDR/IVDR, standard-compliant symbolism and linguistic consistency. We take GSPR requirements and target market specifications into account.
We create comprehensible, translated and formally checked documents - in all relevant EU languages, in digital or physical form - including change tracking, version management and review protocols.
Whether it's a new installation or an extension, we work with you to develop structured processes for approval, updating and linking with UDI, PLM and QMS. This ensures that your marking remains audit-proof - throughout the entire product life cycle.
Clarify your labeling and IFU questions at an early stage.
Related topics - For complete documentation and market access.
These services complement your product labeling - from UDI integration to consistent integration into your quality and approval system.
