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Quality reference
MISEV2023 and Supplier Documentation
Reviewed by ExaVeyra Sciences editorial team · Updated 29 August 2026
MISEV is the most cited document in this field and one of the least read. Suppliers reference it, marketing invokes it, and it is regularly described as something a preparation can comply with, which is not what it is or what it was written to do.
It is worth knowing what it is, because the difference changes what you can ask for and what an answer is worth.
What MISEV is, and what asking for it gets you
MISEV stands for Minimal Information for Studies of Extracellular Vesicles. It is a position statement from the International Society for Extracellular Vesicles telling researchers what to report when they publish, so that one group’s results can be compared with another’s.
That is its whole purpose. It sets no acceptance criteria, defines no pass mark, and describes no product. A preparation cannot be MISEV compliant in the way a device can be ISO certified.
How the 2023 edition changed what to ask for
MISEV2018 was already the reference edition when most current supplier documentation was designed. MISEV2023 replaced it with guidance that is broader in scope and more explicitly graded, distinguishing what is expected from what depends on the study.
The practical consequence is counterintuitive. A newer standard that says "it depends" more often is harder to wave at a supplier, because fewer of its recommendations are unconditional.
Three questions carry most of the weight
Rather than sending a supplier the standard, ask the three things it exists to make answerable. Each one is a question about method, and each has a wrong answer that is easy to spot.
| Ask | A useful answer looks like | A weak answer looks like |
|---|---|---|
| What was the source material, and how was it prepared? | A named cell type, culture conditions, and the separation method with its version. | "Proprietary process." The method does not have to be disclosed in full, but its class does. |
| Which markers were measured, and on what proportion of particles? | Named proteins with the assay used, reported as a measured value. | A logo-style list of markers with no method and no number attached. |
| How was particle concentration determined? | A named instrument and method, because counts are not comparable across methods. | A single particle count with no method. See the particle counting page. |
Where a reporting standard ends and your judgement begins
A complete characterisation package tells you the preparation was measured and how. It does not tell you the preparation is good, and it cannot, because MISEV sets no thresholds to be good against.
That is the right way round. Judging suitability is the prescriber’s call on a named patient, and no reporting standard substitutes for it.
Where this sits against regulation
MISEV carries no regulatory force in the United States. It is a scientific consensus document, and citing it neither creates nor discharges any obligation under 21 CFR Part 1271 or anywhere else.
That separation is worth holding onto, because the two get blended in marketing. A supplier meeting a reporting standard has told you about their documentation. What is permitted, and for whom, is a different question answered by a different body of text.
How to get a characterisation package
A supplier who reports against a standard has the package already assembled, because it exists for their own quality system rather than for your request. Asking during pricing is the point at which it costs them nothing to send.
For ExaVeyra material, characterisation data is released alongside lot-specific certificates once a practice completes NPI verification. That single step opens pricing, the formulary and the document set together.
Sources
- 21 CFR Part 1271, human cells, tissues, and cellular and tissue-based products (accessed 29 August 2026)
Scientific literature
Each source carries the kind of study it was and, where the study enrolled people, how many. Study design decides what a result can establish, so it is stated rather than left to be inferred. Each line also says what that source is carrying on this page.
- Welsh JA, Goberdhan DCI, O’Driscoll L, et al. Minimal information for studies of extracellular vesicles (MISEV2023): from basic to advanced approaches. Journal of Extracellular Vesicles, 2024. doi:10.1002/jev2.12404 PMID:38326288Consensus statementLandmarkSource 1 supports: The current edition of the reporting standard. Cited as the primary text this page describes, so a reader can check the framing rather than take it from a summary.
- Théry C, Witwer KW, Aikawa E, et al. Minimal information for studies of extracellular vesicles 2018 (MISEV2018): a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines. Journal of Extracellular Vesicles, 2018. doi:10.1080/20013078.2018.1535750 PMID:30637094Consensus statementLandmarkSource 2 supports: The prior edition, and the one most supplier documentation was designed against. Cited because a package built to 2018 is not out of date so much as built to a different framing, which is the distinction the page draws.