EU Authorized Representative for Costa Rica: From Zona Franca Export Plant to MDR Market Access

A Costa Rican export plant may hold no Costa Rican registration at all

The starting point is a decree most European buyers have never heard of. Decreto Ejecutivo N° 44696-S-COMEX, the regulation on sanitary authorisation for products entering establishments under the free-zone and active-processing regimes, was announced by PROCOMER on 10 October 2024. Its effect, in PROCOMER's words: "Los productos de interés sanitario ya no deberán contar con el registro sanitario emitido por el Ministerio de Salud." [Products of sanitary interest will no longer need a sanitary registration issued by the Ministry of Health.] Before the decree, free-zone companies had to wait for Ministry registration even to export; afterwards they import inputs on an authorisation form through PROCOMER's single window and export without that registration. Registration remains mandatory only where products are marketed, distributed or used inside Costa Rica.

For a plant that exports its entire output, the consequence is direct. There may be no Costa Rican registration file for the device at all, and nothing about the free-zone regime is a conformity assessment. The regulatory weight of the product sits entirely in the destination market. For devices sold in Europe, that means Regulation (EU) 2017/745, applied in full.

The scale is not small. The Ministry of Foreign Trade (COMEX) reported on 25 August 2025 that the precision and medical equipment sector reached US$6,305 million in exports in January to July 2025, a 48% share of goods exports and the country's leading export sector, with the Netherlands and Belgium among the markets it named.

RTCR 505:2022 has four classes, and none of them maps onto Annex VIII

Devices sold inside Costa Rica are governed by Decreto Ejecutivo N° 43902-S, the technical regulation RTCR 505:2022 on biomedical equipment and material (equipo y material biomédico, EMB), signed on 30 November 2022 and amended by Decreto Ejecutivo N° 44431 of 11 April 2024. Section 8.1 sorts EMB into four risk classes under the rules of its Annex A: "así los de menor riesgo pertenecen a la clase 1, y los de mayor riesgo a la clase 4" [so that the lowest-risk devices belong to class 1 and the highest-risk to class 4]. Section 2.4 then exempts the lowest class: "Los EMB clase I no requieren registro sanitario para su comercialización y uso" [class I EMB do not require sanitary registration for marketing and use].

A four-class numbering invites a one-to-one translation into I, IIa, IIb and III. It should not be done by table. MDR classification runs on the 22 rules of Annex VIII, with sub-classes Is, Im and Ir that change what a notified body must audit. A Costa Rican class 1 with no registration file behind it is the most exposed case: it may become a class Is or Ir device under MDR, and the notified body involvement follows the class.

"If those devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer shall apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI." (MDR Article 52(7))

Costa Rica recognises other regulators; MDR has no equivalent mechanism

RTCR 505:2022 is built around reliance. For imported class 2 devices, Section 11.3 requires the Certificado de Libre Venta from the country of origin, legalised or apostilled. Section 17 goes further: citing Article 6.1 of the WTO Agreement on Technical Barriers to Trade, it allows the Ministry to accept the conformity assessment results of other authorities that have completed the equivalence procedure in its Annex B, and reduces the dossier accordingly.

The Union has no equivalent door. MDR contains no mechanism under which a Costa Rican registration, or a Costa Rican free sale certificate, stands in for Annex II technical documentation or a notified body certificate. The flow is one-directional: a CE-marked device can support a Costa Rican registration, but a Costa Rican registration does nothing for a CE marking.

Who the manufacturer is when the plant belongs to a group

Where a free-zone plant belongs to a larger group, the European question is not where the product is made but whose name is on it. MDR defines the manufacturer as

"a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark" (MDR Article 2(30))

Three situations follow. If the label names a group company established in a Member State, that company is the manufacturer and needs no representative. If it names a parent outside the Union, the Article 11 obligation attaches to that parent, not to the Costa Rican plant. Only when a Costa Rican entity markets the device under its own name does it become the manufacturer carrying Article 10 in full, and then

"Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative." (MDR Article 11(1))

RTCR 505:2022 uses a close equivalent. Its definition of titular del producto is the owner of a device marketed under a specific name or brand who answers legally to the national regulatory authority. Costa Rican regulatory teams therefore already reason in the terms MDR uses.

Costa Rica already requires a resident representative; the Union does the same in writing

Section 10.3 of RTCR 505:2022 provides that where the product holder does not reside in Costa Rica, it must appoint, by power of attorney, a legal representative resident in the country. MDR applies the same logic in the other direction, and puts more into the document. The mandate must be accepted in writing, and the representative's tasks are set by law:

"The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;" (MDR Article 11(3))

The representative also takes on real liability. Where a manufacturer outside the Union has not complied with Article 10, the authorised representative is legally liable for defective devices jointly and severally with it (Article 11(5)). A representative that verifies before it signs is protecting both parties.

Getting the Union side in place from San José, Heredia or Alajuela

Medex Kurumsal Danışmanlık is established in Türkiye. Under the EU–Türkiye Customs Union, the European Commission's March 2022 Notice to Stakeholders states that manufacturers established outside the territory of the EU or Turkey "only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." Medex holds EUDAMED authorised representative SRN TR-AR-000057550. Switzerland and Great Britain require representatives established there (CH-REP and UKRP); Medex does not act in those roles or for the EEA-EFTA states.

The sequence for a Costa Rican manufacturer:

1. Mandate under Article 11(3). A written mandate covering at least all devices of the same generic device group, listing the statutory tasks, including the right to terminate if the manufacturer acts contrary to MDR.

2. Verification. Before signing, Medex checks that the EU declaration of conformity and the technical documentation exist and, where applicable, the notified body certificate. Medex does not write technical documentation, is not a notified body and does not find distributors.

3. EUDAMED actor registration. The Costa Rican manufacturer registers as an actor and obtains its SRN; the mandate is recorded in EUDAMED against Medex's SRN.

4. Basic UDI-DI and UDI. Basic UDI-DIs per device group and UDI-DIs down to packaging level, submitted with the Annex VI core data, which Medex verifies under Article 11(3)(c).

5. PRRC. Medex has an in-house person responsible for regulatory compliance, as Article 15(6) requires.

6. Label and IFU. Annex I, Section 23.2(d) requires "the name of the authorised representative and address of the registered place of business of the authorised representative" on the label.

Published annual fees run from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative. See the pricing page for the full table.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for Mexico, Brazil and the United States. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

Our devices are registered with the Ministerio de Salud. Does that help in Europe?

Not for conformity. A registration under RTCR 505:2022 authorises marketing in Costa Rica and is not evidence that a device meets MDR Annex I. What does transfer is the underlying evidence: sterilisation validations, biocompatibility reports and performance testing produced to recognised international standards can be reused in Annex II technical documentation.

We operate in a free zone and export everything. Do we still need an authorised representative?

It depends on whose name is on the label. If a Costa Rican entity is the legal manufacturer under Article 2(30), yes: Article 11(1) applies regardless of the free-zone regime. If the label names a group company in a Member State, that company is the manufacturer and no representative is needed.

Can our US parent's existing EU representative cover products made in Costa Rica?

If the US parent is the legal manufacturer and the Costa Rican plant is its production site, the parent's existing mandate can cover the devices, provided the mandate extends to the relevant generic device groups. The plant's location does not create a separate Article 11 obligation.

Is a Costa Rican class 1 device automatically class I under MDR?

No. Classify from scratch under Annex VIII. Sterile, measuring and reusable surgical devices fall into Is, Im or Ir, each of which requires notified body involvement for the relevant aspects under Article 52(7).

Sources

Decreto Ejecutivo N° 43902-S, RTCR 505:2022 Equipo y material biomédico (SCIJ / SINALEVI, current version) — pgrweb.go.cr

Ministerio de Salud, Registro de Equipo y Material Biomédico (EMB) — www.ministeriodesalud.go.cr

PROCOMER, Nuevo reglamento agiliza procesos de ingreso de productos de interés sanitario y materias primas a empresas de zona franca (10 October 2024) — procomer.com

COMEX, CP-3073 Sector de equipo de precisión y médico crece un +34% a julio de este año (25 August 2025) — www.comex.go.cr

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

European Commission, Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.

Other countries we cover

We act as EU authorized representative for manufacturers in many markets. See the pages for the United States, Canada, Mexico, Brazil, China and India, or browse the full list by country and the list by device category.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.