--- title: MDR Obligations for Importers and Distributors: A Guide for Startup Sales Channels description: Importers and distributors have specific MDR obligations that affect how startups structure their sales channels — here is what each role requires and how it impacts your go-to-market strategy. authors: Tibor Zechmeister, Felix Lenhard category: MDR Fundamentals & Regulatory Strategy primary_keyword: canonical_url: https://zechmeister-solutions.com/en/blog/mdr-importers-distributors source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # MDR Obligations for Importers and Distributors: A Guide for Startup Sales Channels *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* When your medical device moves from your warehouse to the end user, it passes through a supply chain. Under the MDR, every entity in that chain has defined obligations. Importers and distributors are not passive logistics partners — they are "economic operators" with specific legal duties. For a startup building its sales channels, understanding these obligations is essential for structuring partnerships and contracts correctly. ## Who Is an Importer Under the MDR? Article 2(33) defines an importer as any natural or legal person established within the Union that places a device from a third country on the Union market . An importer only exists when a device crosses into the EU from outside. If you are an EU-based manufacturer selling within the EU, there is no importer in your supply chain. If you are a non-EU manufacturer whose device enters the EU through a local partner, that partner is the importer. ## What Are the Importer's Obligations? Article 13 sets out importer obligations : **Verification before import.** Before placing a device on the market, the importer must verify that: - The conformity assessment has been carried out - The manufacturer has drawn up the technical documentation - The device bears the CE marking - The manufacturer has designated an authorized representative (since the manufacturer is outside the EU) - The manufacturer is identified and has complied with registration requirements **Labeling.** The importer must indicate on the device or its packaging or in a document accompanying the device: the importer's name, registered trade name or registered trademark, and registered place of business. **Storage and transport.** The importer must ensure that storage and transport conditions do not jeopardize the device's compliance with the MDR. **Complaint and vigilance cooperation.** The importer must maintain a register of complaints, non-conforming devices, and recalls, and must keep the manufacturer and authorized representative informed. The importer must forward to the manufacturer complaints and reports about suspected incidents. **Cooperation with authorities.** The importer must cooperate with competent authorities and provide documentation upon request. **Document retention.** The importer must keep a copy of the EU Declaration of Conformity and, if applicable, the relevant certificates issued by the Notified Body, available for competent authorities for the document retention period . ## Who Is a Distributor Under the MDR? Article 2(34) defines a distributor as any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service . Distributors are the intermediaries between the manufacturer (or importer) and the end user. They include wholesalers, local sales partners, hospital suppliers, and any other entity that makes the device available without being the manufacturer or importer. ## What Are the Distributor's Obligations? Article 14 defines distributor obligations : **Verification.** Before making a device available on the market, the distributor must verify that: - The device bears the CE marking - The EU Declaration of Conformity has been drawn up - The device is accompanied by the required information (labeling, instructions for use, manufacturer identification) - The importer has complied with Article 13 requirements (if applicable) **Storage and transport.** Like importers, distributors must ensure storage and transport do not compromise the device's compliance. **Non-conformity management.** If a distributor considers or has reason to believe that a device is not in conformity with the MDR, they must not make the device available until it has been brought into conformity. The distributor must inform the manufacturer and, where applicable, the authorized representative and the importer. **Cooperation with authorities.** Distributors must cooperate with competent authorities and provide information and documentation upon request. **Complaint forwarding.** Distributors must immediately forward to the manufacturer and authorized representative any complaints or reports about suspected incidents. ## How Does This Affect Startup Sales Strategy? For a startup planning its EU sales channels, the importer and distributor obligations create several practical considerations: ### Choosing Distribution Partners Not every company is prepared to fulfill MDR distributor obligations. When selecting distribution partners, verify that they: - Understand their obligations under Article 14 - Have systems for verification, storage, transport, and complaint forwarding - Are willing to include MDR obligations in your distribution agreement - Can demonstrate compliance with storage and transport requirements for your specific device ### Structuring Distribution Agreements Your distribution agreements should explicitly address MDR obligations: - Define the distributor's verification responsibilities - Specify storage and transport conditions - Establish complaint forwarding procedures and timelines - Define cooperation obligations with competent authorities - Address non-conformity management — what happens if the distributor identifies a compliance concern? - Include audit rights — the ability to verify that the distributor is meeting their obligations ### Managing Direct Sales If your startup sells directly to end users (hospitals, clinics, patients), you are acting as both manufacturer and distributor. Your sales operations must comply with both sets of obligations. In practice, this means your order fulfillment, warehouse management, and customer service processes must address: - Proper storage conditions - Delivery in conformity with the MDR - Complaint collection and routing to your quality system - Incident identification and reporting ### Cross-Border Sales When your device crosses EU member state borders, the regulatory picture adds a layer. Each member state's competent authority can conduct market surveillance on devices available in their territory. If you sell through distributors in multiple member states, each distributor must comply with Article 14 in their market. Registration requirements may also vary by member state for some aspects not yet covered by EUDAMED. Monitor the national requirements in each market where you sell. ## When Does a Distributor Become a Manufacturer? This is a critical distinction. Under Article 16 of the MDR, a distributor, importer, or other person is deemed a manufacturer if they : - Place a device on the market under their own name, registered trade name, or trademark (except where they add their details to a device already placed on the market without changing the original labeling) - Change the intended purpose of a device already placed on the market - Modify a device already placed on the market in a way that may affect compliance with the MDR If your distributor rebrands your device, changes the intended purpose, or modifies the device beyond what the MDR permits, they become a manufacturer — with the full set of Article 10 manufacturer obligations. This has practical implications for your contracts. If you allow a distributor to rebrand your device, they take on manufacturer obligations. If they modify the device (beyond permitted activities like repackaging under certain conditions), they become the manufacturer for the modified device. ## Practical Checklist for Startups **If you sell through importers:** - [ ] Verify your importer understands Article 13 obligations - [ ] Ensure your importer is registered - [ ] Include MDR obligations in your importer agreement - [ ] Provide your importer with copies of the Declaration of Conformity and certificates - [ ] Establish complaint and incident forwarding procedures **If you sell through distributors:** - [ ] Verify your distributor understands Article 14 obligations - [ ] Define storage and transport conditions in your distribution agreement - [ ] Establish verification procedures and complaint forwarding timelines - [ ] Include audit rights in the distribution agreement - [ ] Monitor distributor compliance periodically **If you sell directly:** - [ ] Ensure your order fulfillment process meets Article 14 requirements - [ ] Maintain proper storage conditions - [ ] Integrate customer complaints into your post-market surveillance system - [ ] Ensure all customer-facing materials comply with MDR labeling requirements The MDR's supply chain obligations are not obstacles — they are quality controls that protect patients and ensure that the device that reaches the end user is the same device you certified. Structure your sales channels to honor these controls, and they will serve your quality and your business. Next: [The Person Responsible for Regulatory Compliance (PRRC) Under MDR Article 15](/blog/023-prrc-mdr-article-15). --- *This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*