Distribution records
Distribution record requirements are in Schedule 1 (Essential Requirements) and Schedule 3 (conformity assessment conditions) of the UK MDR 2002. Records must be retained for minimum periods and must be detailed enough to enable effective recall and FSCA implementation.
Why distribution records matter
When a device safety issue is identified, the manufacturer must be able to:
- Identify which specific devices (by batch/lot or serial number) are affected
- Identify all distributors, importers, and healthcare facilities to whom those devices were supplied
- Issue the FSN to the right parties
- Verify that the FSCA has reached all affected parties
- Confirm receipt and completion of required actions
Without adequate distribution records, a recall or FSCA is impossible to execute effectively. Inadequate records are a leading cause of ineffective recalls — where affected devices remain in use because the manufacturer cannot identify who received them.
What must be recorded
Manufacturers and importers must maintain records that enable identification of the destination of every device they place on the market. At minimum, records should include:
| Record element | Purpose |
|---|---|
| Device name, model, catalogue number | Identify which product |
| Batch / lot number or serial number | Identify which specific units |
| Quantity supplied | Reconcile recall completeness |
| Date of supply | Determine which batches were within an affected production window |
| Name and address of recipient | Know who to contact for FSN/recall |
| Recipient contact person | Facilitate rapid communication |
| Delivery confirmation reference | Prove receipt |
For implantable devices, records must additionally capture (where available):
- The healthcare facility performing implantation
- Date of implantation
- Patient identifier (held by the facility, not necessarily the manufacturer)
Record retention periods
| Device type | Minimum retention period |
|---|---|
| General medical devices | 5 years from date of manufacture of the last device |
| Implantable devices | 15 years from date of manufacture of the last device |
| AIMDs | 15 years (or expected device lifetime if longer) |
Records and the supply chain
Distributors are also required to maintain traceability records sufficient to support a recall. Healthcare facilities that receive medical devices should maintain their own device receipt records.
The entire supply chain must be traceable from manufacturer to end user. Where distribution goes through multiple intermediaries, each must hold sufficient records to pass traceability information upstream on request.
Related pages
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 3 | Distribution record requirements in conformity assessment conditions |
| MHRA: Post-market surveillance guidance | Record-keeping guidance |