Distributors
Distributor obligations are defined in MDR Article 14 and IVDR Article 14. Definitions appear in MDR Article 2(34) and IVDR Article 2(31).
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and, where appropriate, a qualified regulatory professional.
Who is a distributor?
A distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market until the point of putting into service.
This definition captures a wide range of businesses:
- Wholesale distributors
- Medical device dealers and dealers' networks
- GPOs (group purchasing organisations) that take ownership of devices
- Retailers and online marketplace operators who stock and sell devices
Distributors are distinguished from importers by the fact that they handle devices already on the EU market — they do not bring devices in from outside the EU (that act is importing). A distributor may, however, be the same legal entity as an importer in a vertically integrated supply chain.
Obligations before making a device available
Before making a device available on the market, a distributor must verify:
- The device bears the CE marking
- The device is accompanied by the required information and documentation (instructions for use in the appropriate language, etc.)
- The device has a UDI where required
- The manufacturer and EU REP (if applicable) have been correctly identified on the labelling
- The device's registration in EUDAMED is in place (where the distributor can verify this)
A distributor who has reason to believe a device is non-compliant must not make it available and must notify the manufacturer (or EU REP), the importer, and — where necessary — the competent authority.
Obligations during the supply chain
Once a device is under the distributor's control, they must:
- Ensure storage and transport conditions do not jeopardise conformity with GSPR (e.g. cold chain management for temperature-sensitive devices, handling fragile implants appropriately)
- Cooperate with competent authorities on market surveillance, requests for information, and corrective actions
- Participate in recalls and FSCAs — notify affected downstream parties, facilitate product return
- Keep records of complaints and non-conformities and pass these upstream to the manufacturer or EU REP
- Not supply devices they believe are non-compliant or present a serious risk
Distributor language obligations
Distributors are responsible for ensuring that devices made available in a given Member State include the instructions for use (IFU) and labelling in the official language(s) of that Member State.
If the device does not include the required language version, the distributor must not make it available in that Member State — they must work with the manufacturer to obtain compliant language versions, or cease distribution in that territory.
Adding a language translation to a device is not a simple administrative task. It constitutes a labelling change that must be done in accordance with the manufacturer's QMS and may require the manufacturer to update their DoC or technical documentation.
When does a distributor become a manufacturer?
A distributor becomes a manufacturer — and takes on full manufacturer obligations — if they:
- Place a device on the market under their own name, trademark, or brand
- Modify the intended purpose of a device
- Make any change to a device that may affect its safety or performance, or its conformity with MDR/IVDR
- Repackage a device in a way that affects its integrity or safety
Simply relabelling to add a distributor's own contact details (without other changes) does not automatically make the distributor a manufacturer — but they must notify the manufacturer and ensure this is covered by the manufacturer's QMS and DoC.
Distributor vs importer: key comparison
| Importer | Distributor | |
|---|---|---|
| Brings device from outside EU | ✅ | ❌ |
| Handles device already on EU market | ❌ | ✅ |
| Registers in EUDAMED? | ✅ (SRN required) | Only if also acting as importer or EU REP |
| Name on device labelling? | ✅ Required | Optional (unless required by national law) |
| Can be same entity as EU REP? | ✅ | ✅ |
Record-keeping
Distributors must maintain records sufficient to enable a field safety corrective action to reach the relevant users. Specifically, they must be able to identify:
- Which devices they have made available
- To whom they made them available (hospitals, retailers, patients)
- Over what time periods
These records must be kept for a period that enables traceability and must be made available to competent authorities on request.
Obligations summary
| Obligation | MDR reference |
|---|---|
| Verify CE marking, IFU, UDI, labelling before supply | Art. 14(2) |
| Ensure storage/transport conditions | Art. 14(3) |
| Ensure correct language IFU for target Member State | Art. 14(2)(c) |
| Cooperate with competent authorities | Art. 14(4) |
| Participate in recalls and FSCAs | Art. 14(4) |
| Maintain traceability records | Art. 14(5) |
| Not supply non-compliant devices | Art. 14(3) |
Related pages
- Who needs to comply?
- Manufacturers
- Authorised representatives (EU REPs)
- Importers
- Labelling requirements
- Recalls & field safety
Official references
| Reference | Description |
|---|---|
| MDR Art. 2(34) | Definition of distributor |
| MDR Art. 14 | Distributor obligations |
| IVDR Art. 2(31) | Definition of distributor (IVDR) |
| IVDR Art. 14 | Distributor obligations (IVDR) |
| MDCG 2021-17 | Guidance on economic operators |