Storing and shipping medical devices in the EU
What MDR and IVDR Articles 13 and 14 ask of importers and distributors on storage, transport and checks, and where a third-party warehouse fits.
Under the EU Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746, the importer and the distributor are responsible for storage and transport conditions while a device is under their responsibility. A third-party logistics provider that only stores or transports devices, without owning them, is normally neither importer nor distributor, according to the Medical Device Coordination Group. It carries out the conditions; the legal duty stays with the operator that holds the devices.
That split matters to any manufacturer from outside the EU planning European stock. It decides who must be named on the label, who checks what, and whose name appears when a competent authority asks.
Who is who in the device supply chain?
The MDR defines the roles by what a party does with the device, not by what it calls itself.
- The manufacturer designs or makes the device and markets it under its name.
- The Authorised Representative, required under Article 11 when the manufacturer is outside the EU, acts under a written mandate for specified regulatory tasks.
- The importer is established in the EU and places a device from a third country on the Union market, which is the first making available.
- The distributor is any other party in the supply chain that makes the device available, up to putting into service.
MDCG 2021-27 Rev.1, the Medical Device Coordination Group’s questions and answers on Articles 13 and 14, adds one clarification that shapes European stock plans. The concept of placing on the market applies to each individual device, not to the device type. A device model can therefore have several importers, but one individual device has only one.
Who is responsible for storage and transport conditions?
Both economic operators carry the duty, in slightly different words.
Article 13(5) says importers “shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I.” Article 14(3) says distributors “shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.”
The conditions themselves come from the manufacturer. Annex I, Section 23.2 requires the label to indicate any special storage or handling condition that applies. That label line is the warehouse’s working instruction: temperature range, humidity, protection from light, stacking limits.
Is a 3PL warehouse an importer or distributor?
Not normally. MDCG 2021-27 Rev.1 answers the question directly in Questions 9 and 10.
Some 3PL companies that provide transport or hold devices on a consignment basis only, where the 3PL does not have legal ownership, “may not be considered an importer provided there is a clearly defined agreement between both parties setting out the responsibilities of each party.” Transport is not a distribution activity, so a 3PL doing transport only, even with short in-transit storage, would not be a distributor.
The same answers state the consequence. Although storage or transport may be subcontracted, the importer “retains responsibility over storage and transport conditions” and must ensure the subcontractor’s conditions do not jeopardise compliance. The distributor carries the same responsibility under Article 14(3).
Question 11 covers fulfilment service providers as defined in Regulation (EU) 2019/1020. They are not economic operators under the MDR or IVDR. Where a fulfilment provider’s activities also meet the definition of importer or distributor, Articles 13 and 14 apply to it.
What must importers and distributors check?
Before placing a device on the market, the importer verifies under Article 13(2) that:
- the device is CE marked and its EU declaration of conformity has been drawn up;
- a manufacturer is identified and an Authorised Representative has been designated;
- the device is labelled in line with the MDR and accompanied by the required instructions for use;
- where applicable, a UDI has been assigned under Article 27.
The importer also puts its own name, registered place of business and contact address on the device, its packaging or an accompanying document, under Article 13(3). MDCG notes that the details may be added by a subcontractor, but the importer stays responsible for getting it right.
Before making a device available, the distributor verifies under Article 14(2) the CE marking and declaration, the information supplied by the manufacturer, the importer’s compliance with Article 13(3), and the UDI where applicable. MDCG accepts a sampling method representative of the devices supplied for most of these checks. Distributors also keep a register of complaints, of non-conforming devices, and of recalls and withdrawals, under Article 14(5).
The IVDR repeats this structure for in vitro diagnostic devices in its own Articles 13 and 14, and MDCG 2021-27 Rev.1 addresses both regulations together.
Does a warehouse need to record UDIs?
For class III implantable devices, yes, through the operator it serves. Article 27(8) requires economic operators to store and keep, preferably electronically, the UDI of the devices they have supplied or been supplied with, for class III implantable devices. The warehouse’s receipt and dispatch records are where that data is captured.
For other devices, the UDI is still the natural key for lot, serial number and expiry. Lot, batch and expiry control in an EU warehouse sets out how those records are kept.
EUDAMED adds a registration layer. Under Commission Decision (EU) 2025/2371, four EUDAMED modules became mandatory from 28 May 2026: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance.
A worked example
Suppose a manufacturer of wound-care dressings, established outside the EU, sells to hospitals in Spain and Portugal. The details are hypothetical, for the mechanics only. Its label says “store below 25 °C, keep dry”. It has an Authorised Representative in the EU under a written mandate. Its Spanish distributor buys the devices directly from it, and so becomes the importer for each unit it places on the market.
The distributor contracts a warehouse in Portugal to store and ship the stock, without transferring ownership. The division of work looks like this.
| Task | Who holds the duty | Who carries it out |
|---|---|---|
| Set storage conditions | Manufacturer, on the label | Manufacturer |
| Verify CE marking, declaration, labelling, UDI before placing on the market | Importer | Importer, with sampling by the warehouse if agreed |
| Add importer details to device or accompanying document | Importer | Importer or a subcontractor it instructs |
| Keep storage and transport within the label conditions | Importer | Warehouse and carriers, under contract |
| Register of complaints, non-conforming devices and recalls | Importer and distributors | Importer, with records from the warehouse |
| Regulatory tasks under the mandate | Authorised Representative | Authorised Representative |
The contract between importer and warehouse is where MDCG’s “clearly defined agreement” lives. It should state the conditions, how they are monitored, how deviations are reported and what happens to affected stock.
What happens when a stored device may not comply?
MDCG 2021-27 Rev.1 sets out the obligation in Question 12. If an importer or distributor considers, or has reason to believe, that devices are not in conformity, it informs the relevant parties, the manufacturer and, where applicable, the Authorised Representative or importer, and does not make those devices available.
Complaints follow a similar path. Under Article 13(8), importers that receive complaints or reports from healthcare professionals, patients or users about suspected incidents forward them immediately to the manufacturer and its Authorised Representative. Distributors keep their own register of complaints, non-conforming devices, recalls and withdrawals under Article 14(5).
For the warehouse, that means two practical capabilities: a blocked status that stops suspect devices from shipping at once, and records that let the importer see which units, by lot or UDI, are affected and where the rest went.
Is a fulfilment provider the same as an Authorised Representative?
No. The Authorised Representative is a regulatory role under Article 11, held by mandate, with duties toward competent authorities. Storing and shipping devices is an operational service. One company can in principle do both only if it takes on the mandate and its obligations; they are separate commitments.
This is general information, not legal or regulatory advice. The role of each party in a specific supply chain is confirmed with the manufacturer’s regulatory advisers.
How this runs at EFC
EFC’s base in Portugal, run with its logistics partner, stores and ships stock for medtech brands selling in Europe. In that arrangement, the conditions on the manufacturer’s label are what the warehouse works to, and the importer or distributor keeps its legal duties under Articles 13 and 14. EFC is not an EU Authorised Representative for medical devices and does not act as one. The operation is described on medtech and warehousing; for hospital sales channels, see selling to EU hospitals through public tenders.
Sources
| Label | Value | Source |
|---|---|---|
| Importer obligations | verifications a to d; importer details on device; storage and transport under importer’s responsibility | Regulation (EU) 2017/745, Article 13, EU text on legislation.gov.uk, opened 2026-08-04 |
| Distributor obligations | verifications with sampling; storage and transport per manufacturer’s conditions; register of complaints and recalls | Regulation (EU) 2017/745, Article 14, EU text on legislation.gov.uk, opened 2026-08-04 |
| Label storage conditions | label indicates any special storage and/or handling condition | Regulation (EU) 2017/745, Annex I, Section 23.2, EU text on legislation.gov.uk, opened 2026-08-04 |
| UDI storage | class III implantable devices, economic operators and health institutions | Regulation (EU) 2017/745, Article 27, EU text on legislation.gov.uk, opened 2026-08-04 |
| 3PLs and fulfilment providers | not normally importers or distributors; importer retains responsibility for storage and transport; fulfilment providers not MDR economic operators | MDCG 2021-27 Rev.1, Questions 2 to 4 and 9 to 12, December 2023, opened 2026-08-04 |
| EUDAMED | four modules mandatory from 28 May 2026; Commission Decision (EU) 2025/2371 | European Commission, EUDAMED four first modules mandatory from 28 May 2026, opened 2026-08-04 |