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Assessing corrected and retracted device publications

Trace changes in publication status through the evidence conclusions that previously relied on the source.

Representative research photograph: Assessing corrected and retracted device publications
Photo: Aerzte3welt · License: CC BY-SA 3.0 · Cropped and resized.
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A correction or retraction notice may require reassessment of information used in a device evaluation. Understand the notice and its scope before treating every conclusion identically. Explain which data and claims may be affected.

Scope of the decision

A correction may concern a minor typographical issue, outcome numbers or methodological detail. Retractions can also have different reasons. Verify the notice through an appropriate source and distinguish a publisher statement from commentary. Assess scientific weight and affected decisions with suitable expertise.

Worked review

For example, a correction changes the complication count used in an earlier report. The team does more than replace the PDF. It examines the extracted table, calculated rate and related claim. If the numerical change is judged not to alter the conclusion, explain why; otherwise follow the necessary document and decision processes.

Practical checks

  • Connect the notice type, verified source and affected publication.
  • Locate tables, analyses and claims that used the changed information.
  • Justify decisions to retain or update previous conclusions.

Acceptance and limits

Acceptance requires traceability from publication-status changes to relevant evidence use. Removing a source should not automatically erase the history of an earlier decision. Appropriate record control should preserve the relationship between previous use and the updated assessment.

Frequently asked questions

Does every correction invalidate a study?
No. Assess its scope and effect on relevant results.
Should a retracted source disappear silently from the list?
Follow the applicable record approach and explain effects on earlier claims and the current decision.

Sources

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