Description:
This Literature Search Report for acceptance criteria (AC) documents how we executed a reproducible search and screening to support the acceptance criteria of safety and performance based on similar devices.

• Confirm the objective and the protocol used, and record any deviation with justification.
• Define and justify the search period for AC evidence collection.
• Select search databases (e.g., Embase, PubMed, Cochrane, trials registries) per protocol.
• Apply consolidated search limitations (article type, language, humans) across databases.
• Remove duplicates consistently across sources.
• Capture exact search queries (keywords, connectors, dates, filters) to ensure reproducibility.
• Perform Level-1/Level-2 screening using documented inclusion/exclusion criteria and reasons for exclusion.
• Summarize exclusions using predefined codes and keep a list of retained citations.

Use this report when you need documented, repeatable clinical evidence collection for AC, including published literature and non-published trial data, aligned with MEDDEV 2.7/1 rev.4 expectations.

Key requirements covered include transparent screening decisions and defensible search logic. Level-1 screening reviews titles/abstracts; it matters because it removes clearly irrelevant hits early. Level-2 screening confirms eligibility on full text; it matters because it locks in traceable inclusion decisions.

At Lexqara, we help you build audit-ready CER inputs by optimizing search strategy, screening rules, and reporting—integrated with clinical documentation and post-market activities. Explore our Resource Center [https://lexqara.com/resource-center/] and Clinical Activities [https://lexqara.com/service/clinical-activities/]. See MEDDEV 2.7/1 rev.4 [https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/]. Download the template and request a short gap assessment.

Use it to support CER updates, PMS/PMCF cycles, and consistent evidence traceability across device changes and periodic reviews.