IVD Additional Technical Specifications and the Accuracy and Precision Standard

1. Key takeaways

In addition to the twelve technical specification items of Article 11.4.1, an in vitro diagnostic EMB (EMB-DIV) must be accompanied by two further submissions: the list of the tests the EMB performs (11.4.2 b) and the test performance report (11.4.2 c). On top of these, Article 11.11 requires a separate document identifying the international standard that contains the accuracy and precision standards applicable to the EMB. Article 11.11 is the only documentation item in the main regulation that applies exclusively to IVDs.

• The test list under 11.4.2 b) is a scope statement: what the reagent can measure.
• The performance report under 11.4.2 c) is the evidence file: how accurately it measures.
• Article 11.11 requires an identified international standard with a verifiable number and title, not a generic claim of conformity.
• Article 8.2 classifies an IVD system — analyser, reagents and software — as a whole under the higher risk class.
• For Clase 3 IVDs, Article 12.3 pulls Articles 11.1 through 11.11 into the dossier, so the standard identification document cannot be skipped.

2. Legal basis

The requirements that apply specifically to IVDs are concentrated in Articles 11.4.2 and 11.11, and their reach into the dossier is determined by the classification rules summarised below.

3. Expert insights

Insight 1. The test list required by Article 11.4.2 b) and the performance report required by Article 11.4.2 c) are two different things. The former is a scope statement — what the reagent is capable of measuring; the latter is an evidence document — how accurately and precisely it measures it. During review the two are read against each other: every test named in the list should have corresponding data in the performance report. Submitting the list without the report, or a report that fails to cover every test in the list, is a common reason for deficiency requests.

Insight 2. Article 11.11 requires the applicant to identify the applicable standard, not merely to declare conformity. The Spanish text reads Documento que indique la norma internacional que contenga los estándares de exactitud y precisión aplicables al EMB — a document must be submitted indicating which international standard contains the accuracy and precision standards applicable to the product. This means the applicant must give a verifiable standard number and title that the Ministry of Health can check. A vague statement that the product complies with ISO standards does not satisfy the requirement.

Insight 3. The highest-class rule of Article 8.2 pushes the IVD documentation burden up systematically. Under that provision, when an analyser, reagents and software are used together with another IVD, both are classified under the higher risk class. Consequently, for an IVD system classified as Clase 3, the analyser must also follow Article 12.3 — meaning the dossier must include the standard identification document of Article 11.11. A company filing a system cannot argue that the instrument is exempt from the Article 11.11 document on the ground that the instrument itself does not produce test results.

Insight 4. Article 11.11 and Article 12.4 together lower the difficulty of obtaining IVD registration, but in different directions. Article 12.4 allows a comparative study using representative human samples to replace the clinical evidence of Article 12.2; Article 11.11 externalises the analytical performance requirement to international standards, without requiring local verification. Taken together, the IVD route in Costa Rica runs on international standards plus sample comparison, not on local clinical trials. This is why this guide treats the IVD determination as a standalone topic.

4. Practical recommendations

• Build a dedicated documentation sub-list for IVD projects: the twelve items of Article 11.4.1, plus items b and c of Article 11.4.2, plus the standard identification document of Article 11.11.
• Map the test list against the performance report one to one, so that the report’s data cover every test named in the list.
• In the Article 11.11 document, state the specific international standard number and title, and cite the provisions within that standard that address accuracy and precision.
• Classify IVD systems as a whole under Article 8.2: configure the documentation for the analyser, reagents and software uniformly at the higher class, and do not split the submission.
• For Clase 3 and Clase 4 IVDs, check the documentation scope against Articles 12.3 and 13.2 respectively, so that the Article 11.11 document is not left out.

5. Verification checklist

• □ Test list has been submitted (11.4.2 b)
• □ Test performance report has been submitted and covers every listed test (11.4.2 c)
• □ Applicable international standard identified by number and title (11.11)
• □ IVD system has been classified as a whole under Article 8.2
• □ Documentation scope checked for Clase 3 / 4 IVDs against Articles 12.3 / 13.2
• □ Comparative study route of Article 12.4 has been evaluated

Related reading: [Technical specifications twelve items: Articles 11.4.1 a) to l) of the main regulation](/costa-rica-medical-device-registration/technical-specifications-twelve-items/) | [Clase 3 route: six clinical evidence items and the IVD alternative channel](/costa-rica-medical-device-registration/class-3-clinical-evidence-six-items/) | [Four risk classes and the highest-risk rule](/costa-rica-medical-device-registration/four-risk-classes-and-highest-risk-rule/)

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Costa Rican market. Our team manages Ministry of Health (Ministerio de Salud) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com