Four Risk Classes and the Highest Risk Classification Rule

1. Key takeaways

Costa Rica classifies EMB by risk into four classes, Clase 1 to Clase 4, with Clase 1 the lowest risk and Clase 4 the highest, determined under the classification rules of Annex A. Article 8.1 establishes the highest-risk rule: “Si un EMB puede ser clasificado en más de una categoría, se clasificará en la clase de mayor riesgo” — where a product can be placed in more than one class, it is classified in the class of higher risk. Article 8.2 adds a combination rule for IVDs: where analysers, reagents and software are used together with another IVD, both are classified in the higher risk class.

• Four risk classes, Clase 1 to 4, determined under the Annex A rules (Article 8.1).
• Where more than one class applies, the higher risk class governs (Article 8.1).
• IVD combinations, including analysers, reagents and software, are both classified in the higher class (Article 8.2).
• Products not covered by the rules are classified by administrative resolution of the Ministry of Health (Article 8.3).
• A change that alters the risk classification is treated as a new product requiring re-registration (Articles 10.5 and 10.9).

2. Legal basis

The provisions below set out the four-class system, the Annex A rule structure, and the articles that attach registration consequences to the classification outcome.

3. Expert insights

Insight one: the rule structure of Annex A is group plus number, with general devices and IVDs forming two separate sets. General EMB (A.1) are divided into four groups totalling 16 rules: A.1.1 invasive devices (rules 1–3), A.1.2 non-invasive devices (rules 4–7), A.1.3 active devices (rules 8–12), and A.1.4 special rules (rules 13–16). IVDs (A.2) are divided into three groups totalling 9 rules: A.2.1 uses related to transmissible agents (rules 1–3), A.2.2 other uses (rules 4–5), and A.2.3 special rules (rules 6–9). The order of determination is: first establish whether the product is a general EMB or an IVD, then apply the rules within the group one by one, reaching Clase 1 only through the residual rules (rules 7, 12 and 9).

Insight two: the highest-risk rule and the IVD combination rule stack, making it easy for IVD systems to jump classes. Article 8.1 handles the case of a single product matching several rules; Article 8.2 handles the case of several components of an IVD system used together — both are classified in the higher risk class. By way of example: an analyser classified as Clase 2 under the rules, with a companion reagent classified as Clase 3, places both at Clase 3. The consequence is that dossier requirements jump from Article 11 (Clase 2) to Article 12 (Clase 3, adding six clinical evidence items). When filing IVD systems, companies should determine the class for the system as a whole first, then configure the dossier, rather than filing component by component.

Insight three: classification is not final; the regulation provides two later adjustment channels. Article 8.3 addresses new products not covered by the rules: the Ministry of Health determines their class by administrative resolution, which must be incorporated into the regulation. Article 22.2 addresses products already marketed as Clase 1: where the Ministry of Health has reasonable grounds, it may require a redetermination of the true classification (see articles 07 and 42 of this volume). The two channels run in opposite directions but serve the same purpose — classification authority ultimately rests with the Ministry of Health, and a company’s own determination is only the initial step.

Insight four: a change of classification triggers re-registration as a new product, which is the most expensive classification error. Article 10.5 provides that where a product changes and the change alters its risk classification, it is treated as a new product and a new registration must be filed under Articles 11, 12 or 13; Article 10.9 further provides that a change of intended use (indication) that alters the risk classification likewise requires re-registration. The cost of a classification error is therefore not one supplementary document but starting over. By comparison, changes that do not alter the classification proceed through the 19 categories of post-registration changes in Article 18 at far lower cost.

4. Practical recommendations

• Maintain a classification determination worksheet: first determine general EMB or IVD, then apply the rule numbers one by one, recording the applicable rule, the reasons for excluding other rules and the conclusion, and flag whether the highest-risk rules of Articles 8.1 and 8.2 are triggered.
• Determine IVD systems as a whole: classify analysers, reagents and software in the highest risk class and configure the dossier once.
• For new products not covered by the rules, apply to the Ministry of Health for an administrative resolution under Article 8.3; do not improvise by analogy with nearby rules.
• Before any design change or intended-use extension, perform a classification impact assessment; where the classification would change, plan a new registration under Articles 10.5 and 10.9 rather than the change channel.
• Place the classification conclusion and its reasons at the front of the dossier as the comparison baseline for later changes and renewals.

5. Verification checklist

• □ Determined whether the product is a general EMB or an IVD (deciding whether A.1 or A.2 applies)
• □ Rules applied one by one with rule numbers and conclusions recorded
• □ Checked whether the highest-risk rule of Article 8.1 is triggered
• □ IVD systems checked against the combination rule of Article 8.2
• □ Items not covered by the rules submitted for an administrative resolution under Article 8.3
• □ Changes and intended-use extensions assessed for classification impact (Articles 10.5 and 10.9)

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