The intended purpose is a fundamental regulatory concept that shapes the classification, safety, and market approval of medical and in vitro diagnostic devices.
About this Guide
This guide provides a comprehensive overview of the “intended purpose” as defined in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
It explores the regulatory definition, its key components, and its critical role in ensuring compliance, patient safety, and successful market entry for medical devices and in vitro diagnostic (IVD) devices in the European Union.
Why Is Intended Purpose Important?
The intended purpose is a cornerstone of the MDR and IVDR frameworks, impacting:
- Device Risk Classification: Determines the level of regulatory scrutiny and conformity assessment procedures.
- Clinical Evaluation & Performance Evaluation: Defines the scope of clinical investigations and performance studies required to demonstrate safety and efficacy.
- Post-Market Surveillance (PMS): Guides ongoing monitoring and reporting of adverse events to ensure real-world safety.
Gain a deeper understanding of the intended purpose and its implications for your medical or IVD devices.
Download the guide now to ensure your documentation is audit-ready and fully aligned with EU regulations.
Key Topics Covered
Definition of Intended Purpose: Learn how the MDR and IVDR define intended purpose and its importance in regulatory compliance.
Linked Concepts: Explore related terms such as indications for use, target populations, intended users, and use environment.
Intended Purpose as the Cornerstone of Technical Documentation: Understand how intended purpose influences risk classification, clinical evaluation, and post-market surveillance.
Conclusion: Discover why clearly defining and substantiating intended purpose is critical for regulatory success and patient safety.
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