EU Authorized Representative for Mexico: Contract Manufacturers and Own-Brand Device Exporters
For a Mexican device company the first MDR question is not which class the product falls into. It is whose trademark the product carries, because MDR fixes the identity of the manufacturer on exactly that point, and a large part of Mexico's device output crosses the Atlantic under a foreign label. COFEPRIS meanwhile grants the registro sanitario through equivalence agreements with FDA, Health Canada and Japan and, since 2025, through an abbreviated regulatory route. None of it points towards Europe.
Before anything else: whose name goes on the CE mark?
Mexico is a manufacturing country before it is a brand country. A very large share of what leaves Mexican plants for Europe leaves under somebody else's label, built to somebody else's specification, in a facility that never appears on the packaging. That single fact decides everything about the MDR obligations of a Mexican company, and it is decided by one definition:
"'manufacturer' means 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 mar" (MDR Art. 2(30))
Note what the definition turns on. Not who owns the tooling, not who runs the cleanroom, not who holds the ISO certificate. It turns on whose name or trademark the device is marketed under. A Mexican plant producing infusion sets for a European brand owner is not the manufacturer under MDR; the brand owner is, and if the brand owner is established in the Union no authorized representative is needed at all. The same plant selling the same product under its own trademark in Spain is the manufacturer, and every obligation in Art. 10 lands on it.
What a registro sanitario actually grants
COFEPRIS grants the registro sanitario under the Ley General de Salud and the Reglamento de Insumos para la Salud. Devices are classified as Clase I, II or III under the criteria in article 83 of the Reglamento, and the substantive requirements for granting a registro sit in articles 179 and 180. Around that core sit the Mexican norms a plant lives by day to day: NOM-241-SSA1 for good manufacturing practice, NOM-137-SSA1 for device labelling, and NOM-240-SSA1 for tecnovigilancia.
It is a national market authorisation. It authorises sale, distribution and use in Mexican territory. Nothing in it is addressed to the Union, and the EU operates no instrument that reads it.
Equivalence, reliance and the vía regulatoria abreviada
Mexico's distinguishing feature is not the registro itself but how COFEPRIS reaches it. Article 161 Bis of the Reglamento de Insumos para la Salud empowers the Secretaría de Salud to issue general provisions recognising foreign requirements, tests and evaluation procedures as equivalent to the Mexican ones. Several such acuerdos are in force.
| Reliance source COFEPRIS accepts | Instrument | Any effect under MDR? |
|---|---|---|
| FDA, via sections 510(k) and 514 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Chapter I Subchapter H | Acuerdo de equivalencia, DOF 26 October 2010 | None |
| Health Canada, via the Food and Drugs Act and the Medical Devices Regulations | Same acuerdo, DOF 26 October 2010 | None |
| Japan, via MHLW requirements and PMDA testing and inspection | Acuerdo de equivalencia, DOF 25 January 2012 | None |
| Reference regulatory authorities and WHO prequalification | Lineamientos generales para la aplicación de la vía regulatoria abreviada, DOF 18 July 2025 | None |
COFEPRIS itself defines the two ideas cleanly in its own guidance: recognition is acceptance of another authority's decision, and reliance is giving considerable weight to another authority's assessment while remaining accountable for the decision taken. Both run inbound. Mexico chooses to lean on FDA, Health Canada, MHLW and PMDA. Neither the European Commission nor any notified body operates a reciprocal mechanism that leans on COFEPRIS, and a registro granted through an acuerdo de equivalencia therefore contributes precisely nothing to an EU declaration of conformity.
Three Mexican arrangements and where the MDR burden lands
- Full contract manufacture for an EU-established brand owner. The brand owner is the manufacturer under Art. 2(30) and is established in the Union, so no authorized representative is required. Your plant appears in the notified body's scope as a manufacturing site, and Annex IX allows the auditor onto your premises and those of your own suppliers and subcontractors.
- Contract manufacture for a US, Asian or other non-EU brand owner. The brand owner is the manufacturer and needs a sole authorized representative. Your exposure is operational rather than legal: audit readiness, supplier controls, process validation, traceability and change control, all assessed against MDR rather than against NOM-241.
- Own-brand export. Your Mexican entity is the manufacturer. It draws up the technical documentation to Annexes II and III, signs the declaration of conformity under Art. 19, assigns a Basic UDI-DI, appoints a person responsible for regulatory compliance under Art. 15, and designates an authorized representative, because "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 Art. 11(1))
Firms that move from arrangement one or two into arrangement three are the ones who get hurt, because the plant has years of European audit experience and no experience at all of being the legal manufacturer.
NOM-137 habits against Annex I, Section 23
A Mexican plant labels to NOM-137-SSA1, in Spanish, for a single market. MDR sets the content of the label and the instructions for use in Annex I, Section 23, and the language is determined by each Member State in which the device is made available to the user or patient. Spanish covers exactly one destination market. The content differences bite harder than the language ones: Annex I, Section 23 requires the UDI carrier, the authorized representative's name and registered place of business, specific handling and storage information, and warnings written in terms the intended user can act on. Artwork built for COFEPRIS almost never survives an Annex I review without rework.
Setting up the Article 11 mandate from a Mexican manufacturing base
Medex Kurumsal Danışmanlık is registered in EUDAMED as an authorized representative under SRN TR-AR-000057550, and separately as a manufacturer under TR-MF-000057496 and as an importer. The actor registration, UDI/device registration, notified bodies and certificates, and market surveillance modules of EUDAMED became mandatory on 28 May 2026, which makes the SRN a practical prerequisite rather than an administrative afterthought. Our person responsible for regulatory compliance is in-house, a partner of the firm, with a deputy. We work from Ankara, İstanbul and Gdańsk; pricing is published and class-based with annual fees from EUR 1000. See pricing and the authorized representative service.
Questions from Mexican plants and own-brand exporters
We manufacture under a client's brand. Do we need our own authorized representative?
Not for those products. Under Art. 2(30) the manufacturer is the party marketing the device under its name or trademark, and the Article 11 obligation follows the manufacturer. You will still be audited as a manufacturing site and your contract should say who bears the cost of that.
Our registro sanitario was granted through the FDA equivalence agreement. Does that shorten the EU route?
No. The acuerdo runs inbound to Mexico only. Where it can help indirectly is that the underlying FDA submission dossier your client relied on may contain verification and validation data that is reusable as evidence against Annex I, but the equivalence decision itself has no standing under MDR.
Does our NOM-241-SSA1 certificate satisfy the MDR quality management requirement?
No. MDR Art. 10(9) requires a quality management system covering specified elements, and above unqualified class I that system is assessed by a notified body under Annex IX. In practice this means ISO 13485 as the working baseline plus the MDR-specific elements: regulatory compliance strategy, GSPR identification, clinical evaluation, UDI verification, post-market surveillance and vigilance.
Can one company be both our authorized representative and our importer?
MDR defines them as separate economic operators with separate obligations and separate registrations, and each is registered in EUDAMED in its own right. Medex is registered as an authorized representative and as an importer, so both roles can be discussed in one conversation. Bring us your export structure at contact and we will set out how the operator chain should look before you register anything.