EU Authorized Representative for Argentina: From an ANMAT Registration Under RTM 25/21 to MDR Article 11
Since January 2025 Argentina registers medical devices under Disposición ANMAT 64/2025, which incorporated MERCOSUR's technical regulation GMC Resolution 25/21 and repealed Disposición 2318/2002. The new regulation brought Argentina's twenty-two classification rules very close to the MDR, but with four classes numbered I to IV. An ANMAT registration has no standing in the European Union. An Argentine manufacturer selling in Europe under its own name needs CE marking and a sole authorised representative established in the Union or in Türkiye.
Disposición 64/2025 replaced the 2002 framework
Disposición ANMAT 64/2025, published in the Boletín Oficial on 13 January 2025, incorporated the MERCOSUR regulation into national law and repealed its predecessor:
"Incorpórase al ordenamiento jurídico nacional la Resolución GMC Nº 25/21 “Reglamento Técnico Mercosur de Registro de Productos Médicos (Derogación de la Resolución GMC N° 40/00)”" [The GMC Resolution No 25/21 “MERCOSUR Technical Regulation on the Registration of Medical Devices” is incorporated into national law] (Disposición 64/2025, Article 1)
"Deróganse la Disposición ANMAT Nº 2318/02 y la Disposición ANMAT N° 1285/04." [Disposiciones ANMAT No 2318/02 and No 1285/04 are repealed.] (Disposición 64/2025, Article 3)
ANMAT announced that the new rules apply to initial registration procedures from 21 January 2025, with existing registrations adjusting their class at renewal. The regulation covers medical devices; in vitro diagnostic products are expressly outside its scope (RTM, Part 1, item 4).
Twenty-two rules, four classes
The RTM annexed to Resolution 25/21 contains twenty-two classification rules whose wording closely follows Annex VIII of the MDR. The class labels differ. Argentina uses classes I, II, III and IV; the MDR uses I, IIa, IIb and III:
"Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII." (MDR Article 51(1))
The software rule shows the correspondence. The RTM text reads:
"Los programas informáticos (software) destinados a proporcionar información que se utiliza para tomar decisiones con fines terapéuticos o de diagnóstico se clasifican en la clase II, salvo si estas decisiones tienen un impacto que pueda causar: - la muerte o un deterioro irreversible del estado de salud de una persona, en cuyo caso se clasifican en la clase IV, o - un deterioro grave del estado de salud de una persona o una intervención quirúrgica, en cuyo caso se clasifican en la clase III." (RTM, Appendix II, Rule 11)
The MDR version of the same rule:
"Rule 11 Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: — death or an irreversible deterioration of a person's state of health, in which case it is in class III; or — a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb." (MDR Annex VIII, Rule 11)
The same pattern appears in Rule 19 on nanomaterials and Rule 22 on active therapeutic devices with an integrated diagnostic function, which the RTM places in class IV where the MDR places them in class III.
| Rule outcome | Argentina (RTM 25/21) | EU (MDR) |
|---|---|---|
| Lowest risk | Class I | Class I |
| Rule 11, default for decision software | Class II | Class IIa |
| Rule 11, serious deterioration or surgical intervention | Class III | Class IIb |
| Rule 11, death or irreversible deterioration | Class IV | Class III |
| Rule 22, closed-loop systems and automatic external defibrillators | Class IV | Class III |
The correspondence is a starting point for re-classification, not a substitute for it. Each device should be run through Annex VIII, and the MDR's own implementing rules and guidance, such as MDCG 2021-24 Rev.1, decide borderline cases in the Union.
Reliance on foreign approvals runs into Argentina, not out of it
For imported devices, the RTM asks for proof of registration or a free sale certificate from the country of manufacture or sale:
"en el caso de productos médicos importados, comprobante de registro o certificado de libre comercialización o documento equivalente otorgado por la autoridad competente del país donde el producto médico es fabricado y/o comercializado" [for imported medical devices, proof of registration, a free sale certificate or an equivalent document issued by the competent authority of the country where the device is manufactured and/or marketed] (RTM, Part 3, item 6(d))
A CE-marked device therefore has useful evidence when entering Argentina. The reverse does not apply. The Union has no mechanism by which an ANMAT registration or an Argentine free sale certificate replaces conformity assessment under Articles 52 and 53 of the MDR.
| Argentine instrument | What it does in Argentina | Effect in the EU |
|---|---|---|
| ANMAT registration (classes I to IV) | Authorises marketing in Argentina | None |
| Manufacturer's declaration authorising the importer | Required for imported devices | None; the EU mandate is a separate written document under Article 11(3) |
| ANMAT good manufacturing practice certificate | Confirms manufacturing practice | None; the notified body audits the quality management system itself |
| Argentine free sale certificate | Supports registrations abroad | Not accepted as a conformity route |
The importer's authorisation and the EU mandate
The RTM requires, for imported devices, a declaration by the manufacturer that is legalised or apostilled and gives "autorización explícita para la empresa importadora (solicitante) para representar y/o comercializar sus productos en el Estado Parte" [explicit authorisation for the importing company (applicant) to represent and/or market its products in the State Party] (RTM, Part 3, item 6(c)). In Argentina, the importer can hold the registration.
The EU splits those functions. The importer places the device on the market, but the Regulation also requires a separately mandated authorised representative:
"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))
The authorised representative takes on joint and several liability with the manufacturer under Article 11(5), and the mandate must meet the minimum content set in Article 11(3).
Getting the Union side in place from Buenos Aires, Córdoba or Rosario
Medex Kurumsal Danışmanlık is established in Türkiye. The European Commission's Notice to Stakeholders of March 2022 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." Switzerland, Great Britain and the EEA-EFTA states require their own local representatives; Medex does not act for those markets.
The steps on our side:
1. Written mandate under Article 11(3). It records the minimum tasks, including verifying that the declaration of conformity and technical documentation exist and keeping copies available to competent authorities.
2. EUDAMED actor registration. Your company registers as manufacturer and receives its Single Registration Number, linked to our authorised representative SRN TR-AR-000057550.
3. UDI. Basic UDI-DI and UDI-DI data are registered for each device before it is placed on the market.
4. Person responsible for regulatory compliance. Medex's PRRC is in-house, as the Regulation requires:
"Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union." (MDR Article 15(6))
5. Label and IFU address. Annex I, Section 23.2(d) requires our name and registered address on the label of a device whose manufacturer is established outside the Union. Spanish material prepared for Argentina is a starting point for Spain; each Member State sets its own language requirements under Article 10(11).
Medex works from Ankara, İstanbul and Gdańsk. We do not write technical documentation, we are not a notified body, and we do not find distributors. Annual fees are published on our pricing page, from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative.
Related country and guidance pages
Manufacturers in neighbouring markets face similar questions; we keep separate pages for Brazil, Colombia and Mexico. 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 device is class II with ANMAT. Is it class IIa under the MDR?
Often, because the RTM rules follow Annex VIII closely and class II corresponds to IIa in rules such as Rule 11. It is not automatic. The device must be classified under Annex VIII, and the MDR's guidance decides borderline cases.
Does an ANMAT registration help with CE marking?
Not as an authorisation. The registration has no standing in the Union. Test reports, risk management files and clinical data behind it can be reused in MDR technical documentation if they were produced to recognised standards and are available in full.
Can our Spanish importer act as our authorised representative?
It can accept the mandate if it is established in the Union. It then becomes jointly and severally liable with you under Article 11(5), in addition to its importer obligations under Article 13. Many importers decline the combined role.
Does a Türkiye-based representative cover the whole EU?
Yes. The Commission's March 2022 notice confirms that manufacturers outside the EU and Turkey need only one authorised representative, either in the EU or in Turkey, to place devices on the market in the EU. Switzerland, Great Britain and the EEA-EFTA states require their own local representatives.
Sources
Disposición ANMAT 64/2025, texto original con Anexo (Resolución GMC Nº 25/21) — www.argentina.gob.ar
Boletín Oficial de la República Argentina — Disposición 64/2025 (13 January 2025) — www.boletinoficial.gob.ar
ANMAT — Registro de Productos médicos: Implementación Disposición ANMAT 64/25 — www.argentina.gob.ar
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
Get a fixed-price EU REP quote for your Argentina device range (reply within 1 business day).
Request a proposal · View pricing · Our EU REP service
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 Colombia, Costa Rica, the United States, Canada, 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.