Overview
EN ISO 11980:2025 (ISO 11980:2025) is an international CEN-endorsed standard that specifies requirements and guidance for clinical investigations (CI) to establish the safety and performance of contact lenses and contact lens care products. The document aims to align clinical investigation practices with recognized regulatory expectations worldwide while acknowledging that national laws take precedence. It replaces the 2012 edition and includes updated study design, assessment variables, reporting and grading guidance.
Key topics and technical requirements
- Scope and alignment: Guidance to meet marketing and labelling regulatory requirements for contact lenses and lens care products; note that national regulations override the standard.
- Clinical Investigation Plan (CIP): Must follow ISO 14155 general GCP principles and include a monitoring procedure, pre-defined objectives and a statistical analysis plan. Sample size must be statistically justified.
- Study design and controls: Inclusion/exclusion criteria tied to study objectives (age, lens power range, visual acuity, ocular health). Specific exclusions include active anterior segment disease, recent participation in similar trials, history of herpetic keratitis, and certain slit-lamp findings.
- Modalities covered: Daily wear, extended wear, hydrogel, silicone hydrogel and rigid gas-permeable lenses; requirements for contact lens and contact lens care product evaluations (including wearing modalities and controls).
- Safety and performance variables: Clinical assessment variables and grading scales for ocular tissues, deposits, anterior chamber cells/flare, bulbar conjunctival staining and visual/refractive performance.
- Annexes: Informative annexes provide elements of a CI (Annex A), detailed grading scales (Annex B) and evaluation methods for visual, refractive and lens performance including subjective measures (Annex C).
- Reporting and adverse events: Clarified definitions and handling of serious adverse events, examples of significant adverse events, and guidance for result presentation.
Applications and who uses it
EN ISO 11980:2025 is intended for:
- Contact lens and lens care product manufacturers preparing clinical evidence for regulatory submissions and labeling.
- Clinical investigators and CROs designing and conducting ophthalmic device trials.
- Regulatory affairs and quality teams ensuring compliance with clinical evidence expectations.
- Notified bodies, ethics committees and competent authorities reviewing clinical study designs and data.
- Design and QMS integration - can support conformity with ISO 9001 and ISO 13485 quality systems.
Related standards
- ISO 14155 - Clinical investigation of medical devices - Good clinical practice
- ISO 14534 - Ophthalmic optics - Fundamental requirements for contact lenses and care products
- ISO 18369-1 - Contact lenses - Vocabulary, classification and labelling recommendations
- References in the standard can be used to harmonize CI practices and improve global regulatory alignment.
Keywords: EN ISO 11980:2025, ISO 11980:2025, contact lenses clinical investigation, contact lens care products, clinical investigation plan (CIP), ophthalmic optics standard, safety and performance, grading scales.
