Intended Use
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Use this Intended Use template to clearly define your medical device’s purpose, indications, contraindications, target patient population, users, and environments, as required by EU MDR Annex II and relevant ISO/IEC standards. Completing this document is essential early in product development and for regulatory submissions, as it establishes the foundation for your risk management, clinical evaluation, and usability engineering documentation. Fill it out to ensure regulatory compliance and to provide clarity for all stakeholders regarding your device’s intended application and limitations.