What Documents Should an IVD Supplier Provide
Direct answer: An IVD supplier should provide five documents for a serious purchase: the IFU (instructions for use), the datasheet (performance specifications), the COA (lot-specific test results), the Declaration of Conformity, and the certificates (ISO 13485, CE, registration). They answer different questions — do not accept one in place of another.
The three core documents, and what each answers
| Document | Answers | Why it matters |
|---|---|---|
| IFU (Instructions for Use) | How to run the test, interpret, store | Correct use and interpretation |
| Datasheet | Sensitivity, specificity, LoD, cut-off, specimen | Performance — the technical spec |
| COA (Certificate of Analysis) | Measured results for your specific lot | Proves the lot you bought is in spec |
What to request and why
- IFU — confirms the intended use, specimen and procedure.
- Datasheet — the analytical performance (sensitivity, specificity, LoD, cut-off).
- COA — lot-specific measured values, not a catalogue range.
- Declaration of Conformity — the CE conformity procedure and standards.
- Certificates — ISO 13485 and registration, in the supplier's name.
The Author's Take
Position: In my view, the document most buyers skip — the lot-specific COA — is the one that actually proves the product they are buying, while the datasheet they do ask for describes the product in general.
Reasoning: A datasheet is a specification; a COA is a measurement. Both matter, but only the COA ties performance to the specific lot in your hands. A buyer who asks for the datasheet and skips the COA has asked what the product should be, not what it is.
Disclosure: This is my editorial view as an IVD manufacturer's technical team, not a contractual statement.
By Progene Bio Regulatory Affairs Team · Medical disclaimer · Last reviewed: 2026-09-13