Overview
ISO/TR 22979:2017 provides guidance for assessing when a clinical investigation is needed after design modifications to intraocular lenses (IOLs). It interprets the application of the ISO 11979 series for anterior and posterior chamber IOLs and links design-change evaluation to the risk management process described in ISO 14971. The Technical Report recommends data-analysis approaches and practical evidence sources (bench testing, computational models, literature, usability data) to determine the scope and design of any required clinical study.
Key topics and requirements
- Modification classification (Level A / B / C)
- Level A: Changes that can be justified without clinical investigation (modified model essentially equivalent to parent).
- Level B: Changes that need a limited clinical investigation (the report notes a typical example of about 100 subjects followed 4–6 months).
- Level C: Changes that require a full clinical investigation per ISO 11979‑7 / ISO 11979‑10.
- Risk assessment tied to ISO 14971 - evaluate additional hazards, probability and severity of harm from the modification, and residual risk vs. benefit.
- Evidence sources and analyses - clinical data, literature, validated physical/ numerical models, optical bench testing (ISO 11979‑2), mechanical analysis (Annex B), and human factors/usability studies.
- Technical focus areas
- Optical design changes (monofocal, aspheric, multifocal, toric, accommodative), including effects of tilt, decentration and rotation.
- Mechanical/haptic design and delivery system interactions.
- Material substitutions or new materials and biocompatibility considerations.
- Special anatomical contexts: phakic lenses, anterior chamber lenses, and sulcus‑implanted posterior chamber lenses.
- Study design considerations - pooling data across multiple IOL models only when justified by risk assessment and statistical considerations.
Applications and who uses it
- Medical device manufacturers developing, modifying or extending IOL product lines.
- Regulatory and clinical affairs teams preparing premarket submissions and clinical evaluation plans.
- Design and R&D engineers assessing optical, mechanical or material changes.
- Quality, risk and compliance professionals applying ISO 13485 design controls and ISO 14971 risk management.
- Clinical investigators and study designers deciding whether and how to conduct limited or full clinical investigations.
Related standards
Keywords: ISO/TR 22979:2017, intraocular lenses, IOL design modifications, clinical investigation, risk management, ISO 11979, ISO 14971, optical bench testing.
