ISO 11249:2018

Overview

ISO 11249:2018 - "Copper-bearing intrauterine contraceptive devices - Guidance on the design, execution, analysis and interpretation of clinical studies" provides targeted clinical study guidance for developers and evaluators of copper-containing IUDs. The standard helps ensure scientifically robust clinical investigations to assess safety, clinical performance and contraceptive effectiveness, and to support regulatory conformity and credible reporting of results.

Key topics and technical requirements

• Clinical investigation planning: Structure and content of a Clinical Investigation Plan (CIP) with IUD‑specific considerations.
• Good clinical practice and ethics: Requirements for ethics review, informed consent process, and protection of subject welfare (note: certain trial topics such as compensation and confidentiality are not covered and are addressed in ISO 14155).
• Device identification and preliminary data: Expectations for device description, literature review, preclinical testing and previous clinical experience to justify clinical trials.
• Study design elements: Guidance on objectives, primary and secondary endpoints, comparator selection (device, placebo, or no treatment), subject selection (inclusion/exclusion criteria), procedures and timing (see Annex B on timing of insertion).
• Statistical considerations: Principles for defining hypotheses, sample size justification and analysis plans to support unbiased interpretation.
• Safety reporting: Definitions and handling of adverse events (AE), adverse device effects (ADE) and device-specific events such as expulsion and ectopic pregnancy.
• Trial conduct and quality: Monitoring, audits, deviations, early termination/suspension criteria and publication policy.
• Annexes: Practical examples for inclusion/exclusion criteria and timing of insertion.

Practical applications

• Designing and writing a CIP for a new or modified copper IUD.
• Preparing regulatory submissions and clinical investigation reports to demonstrate device safety and performance.
• Setting up monitoring and AE reporting systems specific to intrauterine devices (e.g., tracking expulsions, bleeding changes, ectopic pregnancies).
• Informing institutional review boards and ethics committees on IUD‑specific trial risks and consent information.

Who should use ISO 11249:2018

• Manufacturers and sponsors developing copper-bearing IUDs.
• Clinical investigators, monitors and research sites running IUD trials.
• Regulatory authorities and conformity assessment bodies evaluating clinical evidence.
• Ethics committees and statisticians advising on trial design and analyses.

Related standards and sources

• ISO 14155 - Good clinical practice for medical device investigations (complements ISO 11249 on many trial design topics).
• ISO 7439 - referenced as part of clinical study requirements.
• WHO/UNFPA specifications and Cochrane reviews cited as background evidence informing IUD trial expectations.

Keywords: ISO 11249:2018, copper-bearing intrauterine contraceptive devices, IUD clinical studies, clinical investigation plan, IUD trials, adverse device effects, informed consent, clinical performance.