Class 3 Clinical Evidence: The Six Items

1. Key takeaways

The Clase 3 dossier requirements are drafted on a cumulative basis: Article 12.1 requires the submission of all documents listed in Articles 11.1 to 11.10, plus the six items of clinical evidence in Article 12.2, namely the clinical evaluation document (12.2.1), preclinical studies (12.2.2), clinical studies in humans (12.2.3), software validation studies (12.2.4), literature studies (12.2.5), and a summary of the risk analysis and evaluation (12.2.6). Documents not in Spanish need only a simple translation; an official translation is not required. IVDs enjoy two special arrangements: an IVD in Clase 3 must submit Articles 11.1 through 11.11, including the accuracy and precision standards (Article 12.3), and it may substitute the clinical evidence with comparative studies on representative human samples (Article 12.4).

2. Legal basis

The provisions below set out the cumulative structure of the Clase 3 dossier, the six clinical evidence items, the IVD-specific provisions, and the translation standard that applies to evidence documents.

3. Expert insights

Insight 1: The translation requirement of Article 12.2 is lower than that of Article 10.13, and the difference has substantive significance. Article 10.13 requires an official translation (traducción oficial) for documents of an official or legal nature, while Article 12.2 requires only a traducción simple, a simple translation, for clinical evidence. The meaning is that evidence documents such as clinical evaluation reports, preclinical studies and literature do not need to be translated by a Costa Rican official translator and may be rendered by a qualified translator. This markedly reduces the evidence-gathering cost of a Clase 3 project, and it is a right that companies should expressly assert when assembling the dossier.

Insight 2: Article 12.2.3 leaves two alternative paths for products without their own clinical studies, and both require a declaration of equivalence plus evidence. The source text allows, where the manufacturer has not conducted clinical studies because the product is based on recognised mature technology, the submission of third-party studies on the product or studies on a similar product, but in both cases a declaration of product equivalence issued by the manufacturer must be attached, and that declaration must contain the evidence of equivalence. The practical meaning of this design is that equivalence is not a bare statement but a technical argument that must be supported by evidence; merely declaring equivalence with some product is not enough.

Insight 3: Article 12.4 is a channel exclusive to IVDs, substituting comparative studies for the full set of clinical evidence. The provision allows comparative investigation studies (pruebas de investigación comparativas) conducted on representative human samples, under conditions of similar intended use, to serve as the clinical evidence, provided a declaration of truthfulness issued by the licence holder is attached, certifying the veracity of the results. For IVD companies this is a more executable path than Article 12.2, especially for mature products that already hold performance verification data.

Insight 4: Article 12.3 extends the dossier range for a Clase 3 IVD to Article 11.11, one item more than the general Clase 3 list. The general Clase 3 list under Article 12.1 runs from Article 11.1 to 11.10; an IVD under Article 12.3 runs from Article 11.1 through 11.11, meaning it includes the international standards document on accuracy and precision of Article 11.11. This single difference is easily missed, yet Article 11.11 is precisely one of the technical documents that an IVD applicant most needs to prepare early.

4. Practical recommendations

• Assemble the Clase 3 dossier on the base of Articles 11.1 to 11.10 first, then add the six clinical evidence items of Article 12.2, without omitting the risk analysis summary of Article 12.2.6.
• Translate evidence documents under Article 12.2 as simple translations only, without processing official translations, but ensure the translations are complete and traceable to the source text.
• For products without their own clinical studies, prepare third-party studies or studies of a similar product under Article 12.2.3, together with a declaration of equivalence supported by evidence.
• For IVDs, evaluate the comparative study channel of Article 12.4 first, and in parallel prepare the declaration of truthfulness of results by the licence holder.
• Remember, for a Clase 3 IVD, to add the international standards document of Article 11.11 as required by Article 12.3.
• For products containing software, prepare the software validation studies required by Article 12.2.4.

5. Verification checklist

• □ Base documents complete under Articles 11.1 to 11.10
• □ Six clinical evidence items added under Articles 12.2.1 to 12.2.6
• □ Clinical evidence simply translated under Article 12.2, without wrongly applying the official translation requirement
• □ Declaration and evidence of equivalence prepared where no own clinical studies exist (12.2.3)
• □ Comparative study channel of Article 12.4 evaluated for IVDs
• □ Article 11.11 document added for a Clase 3 IVD (12.3)
• □ Software validation studies prepared for software-containing products (12.2.4)

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