We’re excited to share the latest update to the IMDRF’s labeling guidelines for medical devices and IVDs. The IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2) document, released on April 26, 2024, outlines the global harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, ensuring clarity and consistency across the industry and the various regulatory jurisdictions.
Read the full publication by the IMDRF here.
Understanding Labeling Elements
The document clarifies the different elements of device labeling and provides basic expectations on these labeling elements:
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- Label
- Instructions for Use (Package Insert)
- Information intended for the patient
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Key Highlights
Key highlights from the updated document include:
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- The document provides detailed guidance on labels, instructions for use, and patient-directed information.
- It references the latest standards and guidance documents to ensure that the information is current and in line with global best practices.
- The global harmonized labeling principles and requirements included apply to Medical devices, including Medical Devices containing Software and Software as Medical Devices (SaMD), and IVDs.
- Specific information is included for medical devices and IVDs for use by lay persons, and information intended for patients.
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Note
While the guidelines focus on general labeling principles, advertising and promotional materials are beyond the scope of this document, though some regulatory authorities may consider these as labeling elements.
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