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Distribution records

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Regulatory basis - MDR Art. 10(8) / IVDR Art. 10(8) — manufacturers must maintain records that allow identification of all customers who received a device, enabling effective recalls and FSCAs. Importers and distributors have parallel obligations under MDR Art. 13(5) and Art. 14(5).

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Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

Why distribution records matter​

Distribution records are the backbone of recall effectiveness. Without the ability to identify who received affected devices and in what quantities, an FSCA cannot reach all affected parties. Distribution records also support:

  • Post-market surveillance: identifying device utilisation patterns and populations
  • Vigilance investigations: tracing specific lots to patient use locations
  • Regulatory inspections: demonstrating supply chain traceability to NCAs
  • EUDAMED compliance: UDI-linked distribution data

What must be recorded​

Manufacturer — outbound distribution records​

Manufacturers must maintain records sufficient to identify the destination of every device placed on the market, linked to the UDI:

Data elementDescription
UDI-DIDevice model identifier
UDI-PI (lot/serial/expiry)Specific production unit or batch
QuantityNumber of devices in each shipment
Customer identityName and address of each direct customer (distributor, hospital, etc.)
Dispatch dateDate the devices were shipped
Delivery confirmationEvidence of receipt where available

For implantable devices, the UDI-PI (including serial number) must be traceable to individual patients where possible, through healthcare institution records.

Importer — records​

Importers must keep records of:

  • The devices they have imported (UDI, lot numbers, quantities)
  • The EU customers they have supplied to
  • Any complaints received relating to devices they have imported

Distributor — records​

Distributors must maintain records of:

  • Devices received (UDI, lots, quantities, supplier)
  • Devices supplied onwards (UDI, lots, quantities, customer identities)
  • Any complaints received

These records enable the recall chain to function — if a manufacturer initiates a recall, it can identify importers; the importers can identify distributors; the distributors can identify the hospitals or end users.

Retention periods​

Distribution records must be retained for:

  • 15 years after the last device was placed on the market — for all devices except implantables
  • 30 years after the last device was placed on the market — for implantable devices

These retention periods are among the longest in any industry and must be planned for in document management and IT systems.

Format — paper vs. electronic​

MDR/IVDR does not mandate electronic records, but the practical requirements (volume of data, retrieval speed needed for recalls, EUDAMED integration) make electronic records the only viable approach for most manufacturers.

Records must be:

  • Accessible within a reasonable time when requested by an NCA
  • Protected against loss or corruption — backup and disaster recovery required
  • Exportable in a usable format — NCA inspections require readable records

UDI and distribution records — the link​

The UDI system is designed to underpin distribution traceability. Distribution records must be linked to the UDI of each device dispatched:

  • The UDI-DI identifies the device model
  • The UDI-PI (lot or serial number) identifies the specific production unit

For Class IIb and above (MDR) and Class C and D (IVDR), the granularity of distribution records should enable tracing of individual lots to specific customers.

Healthcare institution records​

Healthcare institutions have their own obligation to keep records of UDIs for implanted devices in patient records. This creates a chain:

Manufacturer distribution records → lot/serial number at hospital
Hospital implant records → UDI linked to specific patient
Patient implant card → patient-held record of device UDI

This chain enables identification of all patients with a specific affected device lot in the event of an implant recall — a capability that was poorly developed under the old MDD system.

Official references​

ReferenceDescription
MDR Art. 10(8)Manufacturer record-keeping obligations
MDR Art. 13(5)Importer record-keeping
MDR Art. 14(5)Distributor record-keeping
MDR Art. 27(9)Healthcare institution UDI storage obligation
MDR Art. 87(1)Distribution data in vigilance reports
IVDR Art. 10(8)IVDR equivalent obligations