Institute of European Standards and Quality 
Reference details
- Reference
- EN ISO 18113-3:2011
- Title
- In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
- Organisation
- CEN
- Publisher status in source
- WithdrawnThis is the status recorded in the source, not a statement that this is the latest edition.
- Source access
- 19 October 2026
Research and application
Begin with the official scope and the product configuration. The title identifies a subject; it does not establish every product, use condition or legal requirement covered by the publication.
Product research routes
- Medical devices
Intended medical purpose, device classification and the evidence associated with design, performance and lifecycle controls.
- In vitro diagnostic products
Specimens, intended purpose and analytical and clinical performance for diagnostic devices and systems.
- Measurement, test and laboratory equipment
Measurement function, accuracy claims, electrical safety and the conditions under which results are comparable.
Questions for the evidence file
- Intended purpose
- Classification rationale
- Risk management
- Verification and performance evidence
- Clinical evidence scope
- Assay configuration
Record the exact edition and associated amendments, the assessed object, the evidence examined and the limits of the conclusion. Explore IESQ research for detailed product and standard studies.
Legislation reference records
The following records come from Commission information lists. A source listing, a publication status and a legal presumption of conformity answer different questions. Check the applicable Official Journal acts, dates and restrictions for the intended claim.
In vitro diagnostic medical devices (Directive 98/79/EC)
An absent date or restriction field is not confirmation of current legal status.