EU Authorized Representative for Colombia: From an INVIMA Registro to MDR Annex VIII

Decreto 4725 classifies with eighteen rules that Europe has since replaced

Article 5 of Decreto 4725 of 26 December 2005 (Diario Oficial No. 46.134) places classification in the hands of the manufacturer and sets four classes: I (low risk), IIa (moderate risk), IIb (high risk) and III (very high risk). Article 7 then lays down the rules, numbered 1 to 18. Rule 18 is a good marker of where they came from: "No obstante lo dispuesto en otras reglas, las bolsas para sangre se incluirán en la clase IIb." [Notwithstanding the other rules, blood bags shall be placed in class IIb.] The structure and the class labels follow Annex IX of the former Medical Devices Directive 93/42/EEC.

That Directive has been repealed. Its successor sets classes on a new basis:

"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))

Annex VIII has twenty-two rules. The additions cover software, nanomaterials, substances introduced into and absorbed by the body, and active therapeutic devices with an integrated diagnostic function, and several existing rules were tightened. The labels are identical in Bogotá and Brussels; the answer for a given product may not be. A Colombian manufacturer whose INVIMA file says IIa should re-run the Annex VIII rules before assuming the MDR class is the same.

Reference-country reliance in Decreto 4725 runs in one direction

Decreto 4725 gives European approvals real weight in Colombia. For imported devices, Article 29(b) requires a certificate from the authority of the country of origin and, where the product is not used there, a free sale certificate from "un país de referencia (Comunidad Económica Europea, Estados Unidos de Norte América, Canadá, Japón y Australia)" [a reference country: the European Economic Community, the United States, Canada, Japan and Australia]. A paragraph added to Article 18 by Decreto 3275 of 2009 goes further: for class I, IIa and IIb devices, a free sale certificate from a reference country, issued within the past year, may be presented to meet several of the technical documentation items.

For a foreign manufacturer entering Colombia, that is a meaningful shortcut. For a Colombian manufacturer entering Europe, there is no mirror image. The Union has no reference-country list, no reliance on INVIMA decisions and no route by which a registro sanitario shortens a notified body review. The same reliance that eases imports into Colombia gives Colombian exports no credit in the other direction.

Registro sanitario automático and the class I and IIa assumption

Articles 16 and 17 of the Decreto split the Colombian route by class. Class IIb and III devices need a registro sanitario after technical, scientific and quality evaluation. Class I and IIa devices need a registro sanitario automático, issued once the required documents are verified as complete. Both authorise production, import, export and sale in Colombia, and Article 31 gives them a validity of ten years.

The risk is carrying the Colombian grouping into Europe. Under MDR, class I and IIa are not treated alike. Class I devices, other than the sterile, measuring and reusable surgical instrument sub-cases, are self-declared:

"Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III." (MDR Article 52(7))

Class IIa devices, by contrast, need a notified body certificate. A Colombian range that moved through INVIMA together on the automatic route may divide into two different European procedures, with different timelines and costs.

INVIMA's BPM certificate and the notified body's quality system audit

Colombian manufacturing plants are certified by INVIMA: Article 9 gives INVIMA the task of issuing the Certificado de Cumplimiento de Buenas Prácticas de Manufactura de Dispositivos Médicos after periodic visits, and Article 15 sets its validity at five years. A plant with a current BPM certificate has documented processes, inspected premises and a habit of regulatory visits.

That is good preparation and it is not a substitute. For devices above class I, and for the sterile, measuring and reusable sub-cases of class I, the notified body carries out its own audit of the quality management system against MDR, including the elements listed in Article 10(9): a strategy for regulatory compliance, post-market surveillance, vigilance, UDI and the management of clinical evaluation. The BPM file supplies evidence. It does not replace the audit.

Fabricante in Decreto 4725 and manufacturer in Article 2(30)

Decreto 4725 defines the manufacturer as "la persona natural o jurídica responsable del diseño, fabricación, empaque acondicionamiento y etiquetado de un dispositivo médico" [the natural or legal person responsible for the design, manufacture, packaging, conditioning and labelling of a medical device]. MDR turns instead on the name on the product:

"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))

The practical consequence is the same one Colombian exporters meet with any private-label customer. If a European company puts its name on the device, it is the manufacturer and carries Article 10. If you export under your own brand, you are the manufacturer, and because you are not established in a Member State you must appoint a sole authorised representative under Article 11(1). That representative takes on a real liability:

"the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer" (MDR Article 11(5))

Getting the Union side in place from Bogotá, Medellín or Cali

Medex Kurumsal Danışmanlık is established in Türkiye. Under the EU–Türkiye Customs Union, 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 are outside that arrangement and each requires a locally established representative; 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. Plan Spanish-language material for Spain alongside the other languages each Member State requires 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, Mexico and Costa Rica. We also have a page for manufacturers in Argentina. 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 holds an INVIMA registro sanitario. Does it help with CE marking?

Not as an authorisation. The registro permits production, import, export and sale in Colombia and has no standing in the Union. The evidence behind it, such as test reports, sterilisation validation and design verification, can be reused in MDR technical documentation if it was produced to recognised standards and is available in full.

Colombia accepts EU free sale certificates. Will the EU accept a Colombian one?

No. The reference-country mechanism in Article 29 of Decreto 4725 is a Colombian import rule. The Union has no equivalent list and does not rely on INVIMA decisions. Conformity must be demonstrated under MDR through the procedures in Annexes IX to XI, or by self-declaration for plain class I devices.

Can our Spanish distributor act as our authorized 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) where you have not met Article 10, in addition to its own distributor or importer duties. Many distributors decline the combined role, and it makes a later change of distributor harder.

Does a Türkiye-based representative cover Spain and the rest of the 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

INVIMA — Compilación Jurídica: Decreto 4725 de 2005 (consolidated, including amendments by Decretos 3275 de 2009, 1313 de 2010 and 582 de 2017) — normograma.invima.gov.co

Ministerio de Salud y Protección Social — Decreto 4725 de 2005 (original text) — www.minsalud.gov.co

Council Directive 93/42/EEC concerning medical devices, consolidated text of 11.10.2007 (Annex IX, Rules 1–18) — eur-lex.europa.eu

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.