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May 8, 2026Expert Review of Medical Devices

Methodologies for mapping existent common specification, standards, and overlapping regulation for medical devices: a scoping review

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Authors

FTFrancisco TeixeiraCTCarolina TravassosIUInes Urbano

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Overview

Scoping review maps regulations and standards for medical devices in the EU, US, and China, suggesting improved compliance pathways.

Key Points

  • The aim is to clarify compliance pathways and support regulatory harmonization for high-risk medical devices across different regions.
  • Conducted a scoping review following JBI and PRISMA-ScR guidance.
  • Searched databases including PubMed, Scopus/Embase, and Web of Science for relevant studies.
  • Screened 3093 records, yielding 275 eligible entries regarding MD/IVD regulation and standards.
  • Regulatory frameworks generally align on risk-based classification and lifecycle clinical evidence.
  • Notable differences exist in evidentiary thresholds and software requirements, impacting Small and Medium Enterprises (SMEs).
  • Stronger guidance on common specifications for emerging technologies could simplify global market access.

Cite This Study

Teixeira et al. (2026) studied this question.

synapsesocial.com/papers/69fd7d94bfa21ec5bbf05efchttps://doi.org/10.1080/17434440.2026.2669666
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Clinical Investigations of High-Risk Medical Devices in India, Germany and Canada2025
  2. 2Evidence integration and bridging methodologies for high-risk and innovative medical devices and in vitro diagnostic medical devices: a scoping review2026
  3. 3Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance2026 · 4 citations
  4. 4Regulation of medical devices outside the European Union2012 · 88 citations
  5. 5Comparative Study of Medical Device Regulation in US, EU and Canada2025