Mexico COFEPRIS Announces Revised Draft Labeling Standard

By Nélyda González Lara

This is the third installment in our series regarding Mexico’s medical device regulator COFEPRIS announcement of its revised draft labeling standard.

Continuing our updates over the recently released project for the Norma Oficial Mexicana (NOM) standard for Medical Device labeling, NOM-137-SSA1-2024, part 3 discusses additional expected requirements.

Background on NOM-137-SSA1-2024

COFEPRIS released (March 12) a new draft of the NOM for Medical Device labeling, NOM-137-SSA1-2024. Part two presented fundamental aspects including the label design, identification of the medical device and specific conditions for some of the information. Here we discuss additional considerations related to the intended use, instructions for use (IFU) and risks.

Warnings, precautions and measurements

This draft emphasizes the information related to warnings and precautions. It contains more information about the applicable minimum content the labeling must include in terms of radiation sources, sterilization, single-use/reusable as well as references for notification of adverse incidents. It is important to mention that the symbols in Appendix A on warnings and precautions must be detailed in the instructions for use (IFU).

Intended use of the medical device

This new version states that manufacturers must declare the indication for use and the normal conditions of use through labeling.

Instructions for use (IFU)

The draft NOM now addresses and permits the use of electronic IFUs as well as information for the user regarding the use and proper maintenance of the medical device, as well as the information related to appropriate installations required for its use and special training or particular qualifications of the user.

The IFU must mention the release date of the document or the date of the last revision and if applicable, provide the identification number of the document according to the manufacturer’s quality management system.

The disposition of the device must be included as warnings when there is a risk of infection, environmental danger or physical danger (i.e., radiation sources, needles, supplies contaminated with pathogens).

For in vitro diagnostics (IVDs), it is required that the IFU mentions information on quality control, limitations for use, the usable shelf life, clinical performance and interference substances. In the case of IVD kits, the draft states that each of the components must comply with the labeling requirements if these are used as medical devices or IVDs separately.

IFUs for IVDs must mention the type of tests that these are intended to perform, parameters determined by the IVD, function (screening, monitoring, diagnosis or assistance to diagnosis, prognosis, prediction, complementary diagnosis, etc.) as well as the specific disorder, condition or risk factor of interest to be analyzed. The type of sample used and its handling, target population, principle of the test, limitations of use, and quantity of each reagent in the test (including calibrators and controls) and bibliography will also be a requirement according to the draft.

Quality controls (including traceability) must also be mentioned as part of the IFU considering the procedures for the use of controls, limitations of the quality procedure and clarification regarding decision-making according to the quality controls ( if the result of the test is acceptable or not) and actions that must be taken in case of any control’s failure.

It’s worth mentioning that in terms of clinical performance, IFUs should list characteristics like sensitivity, diagnostic specificity, positive predictive value, negative predictive value, probability ratio, expected values ​​in normal and affected populations, substances or limitations that may interfere like hyperlipidemia or hemolysis, age of the sample that will impact the performance of the test.

Residual risks

Within the safety information, IFUs must be included that mention residual risks (such as information on materials, substances, products and manufacturing waste that may represent a risk to the patient's health). This section may include performance studies and clinical investigations that demonstrate safety and clinical performance (as summaries or as a reference where the user can review this information).

Storage and handling of medical devices

IFUs must contain handling and environmental conditions, avoiding any non-specific parameters that may be open for interpretation or that may be affected by geographic location.

Concluding remarks

We expect there will be limited changes to the proposed NOM. However, until the consultation closes, and this is published in the official diary, it is not official.

In the post that follows, we will cover additional updates on the proposed labeling requirements for Mexico