MDSAP Audit Approach (MDSAP AU P0002) C6-T18: For implantable, life-supporting or life-sustaining devices, keep traceability of components, materials and environment conditions and inspection personnel, require distributors to keep records, record consignees, and meet Canadian implant card and FDA tracking rules

What does C6-T18 require?

Manufacturers of active or non-active implantable devices and life-supporting or life-sustaining devices must be able to trace every component and material and (where they could cause nonconformity) work environment conditions, plus the identity of personnel doing inspection or testing; require agents and distributors to keep distribution records available for inspection; and record the name and address of each consignee shipped to. Canada: Schedule 2 implants must be identified and supplied with implant registration cards or an approved alternative, and distribution records and card information kept (CMDR 54, 66 to 68). United States: where the FDA has issued a tracking order, a tracking system must trace the device to the end user and be audited periodically (21 CFR 821). Clauses: ISO 13485:2016 4.2.1, 7.5.9.2, 8.2.6; MO169 Arts 6, 49, 59; 21 CFR 820.10(b)(2).