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Separating roles of grey literature in device evidence

Connect conference abstracts and other limited sources to questions and information gaps without overstating their strength.

Representative research photograph: Separating roles of grey literature in device evidence
Photo: EU2016 NL from The Netherlands · License: CC BY 2.0 · Cropped and resized.
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A conference abstract or public technical notice may identify a study absent from full journal publications. Its level of detail is different. Rather than excluding it automatically or weighting it like a complete report, assess its contribution and limitations explicitly.

Scope of the decision

Examine purpose, data coverage and verifiability. An abstract can provide a lead to an ongoing study or a possible safety concern. When methods and results are insufficiently described, its ability to support firm performance claims remains limited. Appropriate routes to additional information may be explored.

Worked review

For example, a conference abstract reports favourable results for a new device but does not explain participant selection. The team maps the source and searches for a complete publication or related study information. If none is available, it states the limited contribution rather than presenting the favourable percentage as a definitive result across the intended purpose.

Practical checks

  • Record source type separately from the methodological detail available.
  • Investigate links to complete reports of the same study to avoid duplication.
  • Explain the limit that missing detail places on the appraisal conclusion.

Acceptance and limits

Acceptance requires understanding which question a source informs and what it cannot support. An informal appearance does not automatically make information false, while publication alone does not establish adequate verification. Important unfavourable information should not be discarded solely because of source type.

Frequently asked questions

Can grey literature replace clinical evidence?
There is no universal answer; assess content, quality, device relevance and intended use.
Can an abstract alone support a firm claim?
Missing methodological and outcome detail may substantially limit the strength of that claim.

Sources

  1. MDCG 2020-13 — Clinical evaluation assessment report, literature section
  2. EU 2017/745 — Medical Device Regulation, Article 61 and Annex XIV