Distributor quality agreement: who does what after the device ships.
Yes, you need a quality agreement with each distributor and importer: it sets out who stores, traces, handles complaints and runs recalls once your device leaves your warehouse. In the EU it maps onto the duties Regulation (EU) 2017/745 gives importers in Article 13 and distributors in Article 14.
General information, not legal advice. Local law varies; take local counsel.
Why it sits apart from the commercial agreement
The commercial agreement is about money and territory, and it gets renegotiated. The quality agreement is about patient safety and records. Quality and regulatory teams own it, and it has to keep working during a commercial dispute, because a recall will not wait. Keep it as an annex with named contacts, and make a breach of it a breach of the distribution agreement.
The legal duties it maps to
Each EU economic operator has its own duties. The IVD Regulation, (EU) 2017/746, has matching articles.
- Importers, Article 13. Before placing a device on the market, check the CE marking, declaration of conformity, authorised representative, labelling and UDI. Add their name and address to the device, packaging or a document with it. Check the EUDAMED registration and add their details. Keep storage conditions and a register of complaints, non-conforming devices, recalls and withdrawals, and forward complaints about suspected incidents to the manufacturer immediately.
- Distributors, Article 14. Make similar checks before supply, using a representative sample if they wish. Store and transport as the manufacturer says, forward complaints immediately, keep the same register and cooperate on corrective action.
- Relabelling and repackaging, Article 16. Translating information or changing outer packaging does not make a distributor the manufacturer if it marks the activity on the device or packaging, runs a quality system with procedures for it, tells the manufacturer and the competent authority at least 28 days before making the device available, and submits a notified body certificate for that system.
- Traceability, Article 25. Each operator must be able to name who supplied it and whom it supplied, including hospitals and healthcare professionals, for at least 10 years after the last device is placed on the market, 15 for implantables (Article 10(8)). For class III implantables, operators also store the UDI (Article 27(8)).
Outside the EU the rules vary. Write the agreement to the stricter of your own system and local law. ISO 13485 expects you to control outside parties whose work affects your product, and to keep records that let you trace it. A signed quality agreement shows an auditor that control.
What the agreement contains
| Section | What it settles |
|---|---|
| Scope | Products, sites, territories, and the partner's role: importer, distributor or both. |
| Responsibility matrix | Who does each task, who supports, who is informed. A copyable version is below. |
| Storage and transport | The conditions on your labelling, monitoring where needed, quarantine and segregation. |
| Traceability and UDI | Lot or serial records to each customer, kept for the legal period, produced within an agreed time. |
| Complaints and vigilance | What to capture, where to send it, how fast, with timelines from the agreement and local law. The partner forwards; it does not investigate alone unless agreed. |
| Field safety actions and recalls | You decide, the partner carries it out: customer lists, notices, retrieval, reconciliation, costs. |
| Non-conforming product | Quarantine, return or destruction with records, and who informs the authority when there is a serious risk. |
| Change notification | Changes to products, labels, sites, subcontractors, licences or ownership, notified in advance. |
| Records, audits, training | What is kept and for how long, your right to audit, cooperation in inspections, trained staff. |
| Subcontracting | Your approval for warehouses, couriers and sub-distributors, with the same terms passed down. |
A copyable responsibility matrix
R = responsible, S = supports, I = informed.
| Activity | Manufacturer | Importer | Distributor |
|---|---|---|---|
| CE marking, technical documentation, declaration of conformity | R | I | I |
| Checks before supply: CE marking, declaration, labelling, UDI | S | R | R |
| Importer's name and address on device, packaging or document | I | R | n/a |
| Actor registration in EUDAMED | R | R | n/a |
| Storage and transport to the manufacturer's conditions | S | R | R |
| Receive complaints and forward them at once | I | R | R |
| Investigate complaints, report serious incidents | R | S | S |
| Decide a field safety action or recall | R | I | I |
| Carry out a recall at customers | S | R | R |
| Supply records for its own deliveries: from whom, to whom | R | R | R |
| Translation, relabelling, repackaging | S | R if agreed | R if agreed |
Worked example: surgical instruments into Germany
A US maker of single-use surgical instruments (fictional) appoints a German company as EU importer and distributor, with an independent EU authorised representative. EUDAMED lists 1,990 importer registrations in Germany, the most of any country in our EU importer map, and the Germany page shows the licensed companies there by registry role. The importer offers to add German labels in its warehouse.
That would bring in Article 16: a certified quality system and 28 days' notice. The maker prints German labelling itself, so the importer only checks, stores and ships. The agreement names the importer for checks, storage, lot traceability and forwarding complaints, and the maker for investigation, incident reports and recalls.
Common mistakes
- A generic template with no named contacts, or timelines slower than local law.
- Forgetting sub-distributors and outside warehouses.
- Letting a partner relabel without the Article 16 conditions.
- Never testing it. Run a mock recall once a year and time the customer list.
Check licences and procedures first (due diligence) and see how the Index labels registry roles.
General information, not legal advice. Local law varies; take local counsel.
Questions people ask
Do I need a quality agreement with a distributor?
In practice, yes. EU law gives importers and distributors their own duties for checks, storage, complaints and recalls, and ISO 13485 expects you to control outside parties. The agreement makes those duties specific.
What does EU MDR require from distributors and importers?
Importers (Article 13) check CE marking, declaration, labelling and UDI, add their name and address, register in EUDAMED and keep a complaints register. Distributors (Article 14) make similar checks, keep a register and forward complaints immediately.
What should a quality agreement include?
Scope, a responsibility matrix, storage and transport, traceability and UDI, complaints and vigilance, field safety actions and recalls, non-conforming product, change notification, records, audits, training and subcontracting.
Who handles complaints and recalls?
The distributor or importer receives complaints and forwards them to the manufacturer immediately. The manufacturer investigates, reports serious incidents and decides on recalls. The distributor carries out the recall at its customers using its supply records.
Does relabelling change the distributor's role?
It can. Under Article 16, a distributor that translates labels or changes outer packaging stays out of the manufacturer role only if it meets set conditions, including a certified quality system and 28 days' notice. Selling the device under its own name generally makes it the manufacturer.
Pick partners who can carry the duties.
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Sources: Regulation (EU) 2017/745 on medical devices, Articles 10(8), 13, 14, 16, 25 and 27(8) (EUR-Lex), and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Articles 13, 14 and 16 (EUR-Lex); EUDAMED actor module, snapshot of 22 October 2026, as published in our EU importer map; Bastion Hale Distributor Index, build 2026-10-25T12:02:08Z and its source notes. Registry data; Bastion Hale does not vouch for any establishment. This guide is not legal advice. Last reviewed 25 October 2026.