IVD and Laboratories
ISO 18113: Labeling and Instructions for IVD Medical Devices
ISO 18113 covers the information supplied by the manufacturer with in vitro diagnostic medical devices: labels, instructions for use and related documents. It's split into parts for terminology and general requirements, then reagents and instruments, each for professional use and for self-testing.
At a Glance
- Standard
- ISO 18113
- Subject
- Labeling and Instructions for IVD Medical Devices
- Group
- IVD and Laboratories
- Industries
- 1 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
The content requirements track what a user needs to run a test correctly and interpret the result: intended purpose, test principle, reagent composition, storage and stability, specimen requirements, procedure, quality control, calculation and interpretation of results, limitations, performance characteristics, and warnings and precautions. The instrument parts address installation, operation, maintenance and troubleshooting.
The self-testing parts are written for a lay user. Instructions need to be understandable without laboratory training, results need to be interpretable with clear next steps, and that understanding is usually evaluated with intended users. This links labeling directly to usability work and to the performance claims the instructions make.
Regional regulations set their own labeling requirements, and the standard is used to help meet them rather than replace them. Labeling also has to stay consistent with the evidence behind it: stability claims with stability studies, performance figures with performance evaluation, and symbols with ISO 15223-1.
Who It Applies To
- Manufacturers of IVD reagents, calibrators and control materials
- Makers of IVD instruments and analyzers
- Self-test and home use IVD manufacturers
- Firms updating instructions for new markets or after performance or stability changes
What Auditors Check
Claims Traceable to Evidence
Every performance, stability and specimen claim in the instructions traced to a study report or verification record.
Labeling Change Control
Labeling changes reviewed and approved under document control, with the design or evidence change that triggered them recorded.
Lay User Evaluation
For self-tests, evidence that the instructions and result interpretation were evaluated with intended lay users.
Symbol Use
Symbols consistent with ISO 15223-1 and explained where needed.
Label and IFU Version Control
A clear link between product lots and the label and instructions versions issued with them in production records.
Related Services
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Industry Guides That Reference ISO 18113
ISO 18113
Check Your Quality System Against ISO 18113
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
