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 and AIMD devices, records must additionally capture (where available and where feasible to obtain):
- Patient name and unique patient identifier (if traceable to the healthcare facility)
- Patient date of implantation
- Healthcare facility name and location
- Implanting clinician name
- Device serial number
- Specific lot/batch number
This higher level of traceability is essential to support rapid patient notification in case of safety issues or recalls affecting implanted devices.
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 |
Upon cessation of business, the distributor or importer must transfer all distribution records to the manufacturer or another party capable of maintaining them. The manufacturer remains responsible for ensuring that distribution records are retained for the full retention period even if the original distributor no longer exists. The transfer of records must be documented and traceable.
Upon cessation of business: When a distributor or importer ceases business, all distribution records must be transferred to the manufacturer or another party capable of maintaining them. The transfer must include:
- A formal written transfer agreement documenting who is assuming custody
- A complete inventory of records being transferred (by date range, device type, batch numbers)
- Confirmation that the receiving party has committed to retention for the full retention period
- Evidence that the transferring party has made reasonable efforts to locate and transfer all relevant records
The manufacturer remains legally responsible for ensuring records are retained for the full period even if the original distributor no longer exists.