Ecuador IVD Performance Studies: Article 24 Item 2.4 Requirements and Article 52 Instruction for Use

1. Key takeaways

Performance studies for in vitro diagnostic devices (DMDIV) in Ecuador are governed by item 2.4 of Article 24, which applies to all risk classes and covers 4 categories of studies: precision, repeatability and reproducibility; sensitivity; specificity; and other applicable performance or clinical studies — accuracy, detection limit, linearity, interference, robustness and comparable parameters, conducted in accordance with internationally recognised guidelines and technical standards.

The practical estimate used by GRZAN is that an IVD dossier in Ecuador succeeds or fails on the alignment between the performance claims and the study data: the instruction for use must state the performance characteristics and the limitations of the method, and every stated claim must be traceable to a study in the file. Companies that maintain a claim-to-data mapping table from the first draft of the dossier avoid the most frequent correction findings in this product family.

2. Legal basis

The elements listed by Article 52 for the IVD instruction for use are: the trade name; the application and intended use; the components and the kit contents; the methodology; the principle of the method; the performance characteristics and the limitations of the method; the preparation of the reagents; the storage conditions and stability of the reagents; the specimen or sample; the operating procedure; the internal quality control; and the reference intervals, where applicable.

3. Expert insights

Insight one: IVD performance studies carry no class threshold — all risk classes are covered alike. Unlike the tiered logic applied to other study types, item 2.4 applies to DMDIV of every risk class. The reason is structural: the risk of an in vitro diagnostic lies in the clinical consequences of an incorrect test result, which exists at every class level.

Insight two: the fourth category is an open list, and the methodological basis must be internationally recognised. After listing accuracy, detection limit, linearity, interference and robustness, the text closes with other performance studies conducted in accordance with internationally recognised guidelines and technical standards. This gives companies an explicit basis for applying the methodologies of CLSI, ISO and comparable standard-setting bodies.

Insight three: the performance conclusions must correspond line by line with the instruction for use. Article 52 requires the IVD instruction for use to state the performance characteristics and the limitations of the method, and those statements must be directly supported by the study data of item 2.4. Claims that exceed what the data support are a common cause of both corrections and failures in Type 2 post-market sampling.

Insight four: the grouped certification conditions and the performance studies constrain each other. Article 14 requires that the IVD products covered by a single registration certificate belong to the same analytical methodology and the same group of analytes to be detected. Reagents based on different methodologies cannot be merged into one certificate even when their performance studies are complete.

Insight five: Article 32 sets a separate ceiling of 50 entries for DMDIV. The ordinary procedure of Article 10 allows 100 entries for devices and 50 for in vitro diagnostics; the simplified procedure of Article 32 mirrors the split, with 100 entries for DMI, DMNI and DMA and 50 for DMDIV. Batch planning for IVD product families must therefore be calculated on the 50-entry practical estimate.

The 50-entry ceiling interacts with the grouping rule of Article 14 in a way that deserves explicit arithmetic. Because a certificate may only contain reagents of the same analytical methodology and the same analyte group, a product family that spans two methodologies cannot simply be split into batches of 50 — it must first be split by methodology, and each resulting group must then stay at or below 50 entries. A family of, say, 120 immunoturbidimetric assays and 80 enzymatic assays becomes two projects, not three, only if each methodology group fits within the ceiling; otherwise the change procedure of the regulation becomes the expansion route once the initial certificates are granted. Building this arithmetic into the project plan before submission avoids the suspension that Article 10-type over-limit handling imposes on applications awaiting correction.

4. Practical recommendations

1. Build a standard template around the 4 study categories: cover precision, repeatability and reproducibility, sensitivity and specificity, and select the fourth-category studies according to the characteristics of the product.
2. Cite the international standard behind each methodology: reference the relevant CLSI or ISO documents to satisfy the internationally recognised requirement.
3. Align every performance claim in the instruction for use with the study data: maintain a claim-to-data mapping table as a living document.
4. Group applications by methodology and analyte group: file reagents based on different methodologies in separate applications.
5. Batch IVD families at the 50-entry ceiling: extend the scope beyond it through the change procedure rather than exceeding the limit.

5. Verification checklist

One more alignment point closes the loop between the studies and the label. Article 49 requires the label to state the storage conditions and, where applicable, the expiry date, and Article 52 requires the instruction for use to state the storage conditions and stability of the reagents. The values printed on the label and in the instruction for use must therefore be the same values the stability and real-time data support; a kit whose studies were run at a narrower temperature range than the label claims has a claim-to-data gap that the mapping table described above is designed to catch before submission rather than after a correction finding.

• □ Precision, repeatability and reproducibility studies have been completed.
• □ Sensitivity studies have been completed.
• □ Specificity studies have been completed.
• □ The fourth-category studies have been completed according to the product characteristics, with the international standard basis cited.
• □ Every performance claim in the instruction for use corresponds to the study data.
• □ Applications have been grouped by methodology and analyte group.
• □ Batch planning has been completed within the DMDIV limit of 50 entries.

Regulatory information verified as of October 29, 2026

GRZAN supports manufacturers, importers and authorised representatives preparing IVD performance study packages for Ecuador medical device registration, from Article 24 item 2.4 study templates and CLSI-aligned methodologies to claim-to-data mapping against Article 52. For tailored assistance with your Ecuador medical device registration, contact us at info@grzanglobal.com.