Saturday, June 22, 2024

Advancements in Medical Device Labeling: COFEPRIS’s Revised Draft Standard

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Mexico’s medical device regulatory authority the Federal Committee for Protection from Sanitary Risks (COFEPRIS), has recently announced the updated draft for the Norma Oficial Mexicana (NOM) regarding medical device labeling, NOM-137-SSA1-2024. This update marks the third installment in a series aimed at providing comprehensive insights into Mexico’s evolving medical device regulations.

On March 12, COFEPRIS released the new draft NOM-137-SSA1-2024, focusing on key aspects of medical device labeling that include label design and identification requirements. The updated standards not only emphasize improved clarity in labeling but also address the specific conditions under which the information should be presented, ensuring that medical devices used within Mexico meet stringent safety and usage criteria.

This latest installment delves deeper into additional requirements that manufacturers must adhere to, enhancing the safety and efficacy of medical devices. The draft specifies that all labels must include detailed information on warnings, precautions, and essential measurements, particularly concerning radiation sources, sterilization methods, and the stipulations for single-use and reusable devices.

Revised Standards for Medical Devices and IVDs: Clear Labeling and Digital IFUs Required

One significant update in the revised standard is the requirement for manufacturers to explicitly declare the intended use of the device and the normal conditions of its operation through clear labeling. The draft now accommodates electronic Instructions for Use (IFUs), aligning with modern digital practices and supporting environmental sustainability by reducing paper use.

The IFU must include comprehensive details such as the date of document release or last revision, and if applicable, the identification number correlating with the manufacturer’s quality management system. The documentation should also cover appropriate installation procedures, necessary special training, and qualifications required for users, enhancing user competence and safety.

For in vitro diagnostics (IVDs), the draft mandates that IFUs must incorporate information regarding quality control, usage limitations, shelf life, clinical performance, and potential interference substances. If the IVD kits are used as separate components, each must comply with the labeling requirements as individual medical devices or IVDs.

Medical Device

Detailed Test Information, Quality Controls, and Safety Measures Required

The IFUs for IVDs should detail the types of tests performed, the parameters the IVD determines, and their function—whether for screening, monitoring, diagnosis, or other medical purposes. Additionally, it should specify the disorder, condition, or risk factor being analyzed, the type of sample required, its handling, target population, principle of the test, limitations of use, and quantity of each reagent in the test, including calibrators and controls.

Quality controls, including traceability, must be explicitly addressed in the IFU, outlining the procedures for using controls, limitations of quality procedures, and decision-making processes based on quality control results. Actions to be taken in case of control failure must be clearly described to ensure reliability and safety. The IFU should also inform users of residual risks associated with materials, substances, products, and manufacturing waste that could pose health risks. This section could include summaries of performance studies and clinical investigations that verify the safety and clinical performance of the device.

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While the proposed NOM is subject to further changes pending the closure of the consultation period, this update reflects COFEPRIS’s commitment to enhancing medical device safety through precise and clear labeling. The forthcoming posts will continue to explore additional updates on Mexico’s proposed labeling requirements.


Resource: EMERGO by UL, May 08, 2024

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