Consignment stock and loan sets for EU hospitals

Consignment stock is device stock placed at a hospital that remains the supplier’s property until the hospital uses it. A loan set is a kit of surgical instruments, often with implants, lent to a hospital for a procedure. The set is returned afterwards for checking and replenishment. Both depend on a warehouse that tracks every component by lot, serial number or UDI. That is because the Medical Devices Regulation (EU) 2017/745 ties implants to patients through the implant card in Article 18. It also ties them to supply records through the UDI rules in Article 27.

For a manufacturer from outside the EU, these flows are often the price of entry to surgical specialties. A hospital will not hold its own stock of every implant size, so the supplier holds it, at the hospital or one short trip away.

What is consignment stock in a hospital?

In the usual arrangement, the supplier places a defined range of devices on the hospital’s shelves. The hospital does not pay for them on delivery. When a device is used, the hospital reports it, the supplier invoices it, and the supplier replaces it so the agreed range is complete again.

Three records keep the arrangement honest. The supplier needs to know what sits at each hospital, by lot or serial number and expiry. It needs a regular count, reconciled against usage reports. And it needs a rule for stock that nears expiry at the hospital, which usually comes back and is replaced before its date.

The warehouse’s part is replenishment and rotation. That means picking the replacements, shipping them against the usage report, and receiving back the items withdrawn for expiry or damage.

How does a surgical loan set move between warehouse and hospital?

A loan set follows a loop. The details differ by manufacturer and hospital, but the stages are consistent.

1. Request. The hospital books a set for a scheduled procedure.
2. Preparation. The warehouse picks a complete, checked set: instrument trays and, where included, an implant range, each item recorded by lot or serial number.
3. Delivery. The set arrives before the procedure, in time for the hospital’s own processing.
4. Use. The hospital records which implants were used and for which patient.
5. Return. The set comes back with a record of what was used.
6. Check and replenish. The warehouse checks the set against its list, records the lots returned, and replaces used and expired items. The warehouse holds the set until it is complete and released for the next booking.

Reprocessing of reusable instruments follows the manufacturer’s instructions. Annex I, Section 23.4(n) of the MDR sets a requirement for the instructions for use of a reusable device. They must give information on the processes for allowing reuse, “including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation.” Where each step happens, at the hospital or elsewhere, belongs in the agreement between manufacturer and hospital. So does the status a set must have when it leaves the hospital.

Who fills in the implant card?

The manufacturer and the hospital share it.

Under Article 18(1), the manufacturer of an implantable device supplies, with the device, information allowing its identification. That information is supplied “including the device name, serial number, lot number, the UDI, the device model,” and the manufacturer’s name, address and website. It also supplies warnings, expected lifetime and follow-up information, written to be readily understood by a lay person. It provides the implant card itself.

Under Article 18(2), the health institution makes that information available to the patient and gives the patient the implant card, which bears the patient’s identity.

Article 18(3) exempts some implants from these requirements: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.

For a loan set, this means the implants in the kit must travel with their cards and information in the right language, intact. A set whose cards have gone missing is not complete, even if every implant is present.

Which UDIs must be recorded for implants?

Article 27(8) applies where devices are class III implantable devices. For those, economic operators must store and keep, preferably by electronic means, the UDI of the devices they have supplied or been supplied with. Article 27(9) places the same duty on health institutions.

The UDI has two parts. The device identifier, UDI-DI, points to the manufacturer and model. The production identifier, UDI-PI, identifies the unit of production and carries the lot or serial number and dates. For consignment and loan flows, the full UDI can be recorded at each movement, out to the hospital and back. That record is what lets the supplier say which unit went into which procedure, as reported by the hospital.

EUDAMED now supports the registration side. Under Commission Decision (EU) 2025/2371, four modules became mandatory from 28 May 2026. They are actor registration, UDI and device registration, notified bodies and certificates, and market surveillance.

Does holding consignment stock make a warehouse the importer?

Not normally. MDCG 2021-27 Rev.1, the Medical Device Coordination Group’s guidance on Articles 13 and 14, addresses it in Question 9. Some 3PL companies which provide transport or “hold devices on a consignment basis only (i.e. where devices are held at a site by the 3PL, but the 3PL does not have legal ownership of those devices), may not be considered an importer provided there is a clearly defined agreement between both parties setting out the responsibilities of each party.”

The importer, the party with ownership or another property right over the device, keeps the duty to put its details on the device. It remains responsible for storage and transport conditions, even when those activities are subcontracted. Storing and shipping medical devices in the EU sets out the full division.

Worked example: trauma implants for a Spanish hospital

Suppose a manufacturer of orthopaedic trauma implants, established outside the EU, supplies a hospital group in Spain. The details are hypothetical, for the mechanics only. Its EU importer holds a buffer of plates, screws and instrument trays in a warehouse in Portugal, without transferring ownership to the warehouse.

The hospital keeps a consignment range of the most used plates and screws. Each Friday it reports what was used. The warehouse picks replacements by lot, ships them, and records which lots went where.

For less common procedures, the hospital books a loan set. The set leaves the warehouse with each item’s lot recorded and comes back after surgery with a usage record. It is then checked, replenished and released for the next booking.

Plates and screws are exempt from the implant card under Article 18(3). They still carry a UDI, and lot records still matter for any field safety action. Whether the UDI storage duty in Article 27(8) applies depends on the device’s class; it is mandatory for class III implantable devices.

What should the agreements cover?

• Between manufacturer or importer and hospital: ownership, usage reporting, counts, expiry handling, reprocessing responsibilities and the condition of returned sets.
• Between importer and warehouse: storage conditions from the label, set composition lists, lot and UDI capture at each movement, turnaround targets for returned sets, and quarantine rules.
• For both: how a field safety corrective action or recall reaches stock at the hospital and in the warehouse.

Who is the distributor, the importer or neither in a given hospital arrangement is for the manufacturer’s regulatory advisers to confirm. The article describes common arrangements and is not legal or regulatory advice.

How EFC holds consignment and loan-set stock

EFC’s base in Portugal, run with its logistics partner, holds stock for medtech brands supplying European customers. Consignment replenishment and loan-set flows are discussed with each client on the device list, the hospitals served and the records the importer needs to keep. EFC is not an EU Authorised Representative for medical devices and gives no regulatory advice. The operation is described on medtech and warehousing, and hospital buying on selling to EU hospitals through public tenders.

Sources

Label	Value	Source
Implant card	manufacturer’s information and card; health institution gives card with patient identity; exempted implants	Regulation (EU) 2017/745, Article 18, EU text on EUR-Lex, opened 2026-09-10
UDI	UDI-DI and UDI-PI; storage for class III implantable devices by economic operators and health institutions	Regulation (EU) 2017/745, Article 27, EU text on EUR-Lex, opened 2026-09-10
Reuse information	instructions for use give cleaning, disinfection, packaging and validated re-sterilisation information	Regulation (EU) 2017/745, Annex I, Section 23.4(n), EU text on EUR-Lex, opened 2026-09-10
3PL on consignment basis	may not be considered an importer given a clearly defined agreement; importer retains storage and transport responsibility	MDCG 2021-27 Rev.1, Question 9, December 2023, opened 2026-09-10
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 2026-09-10