This report template validates that the patient section of an SSCP is written in plain English by measuring readability using Flesch Reading Ease and Flesch–Kincaid Grade Level, with a defined acceptance criterion and documented results.

• Apply Flesch Reading Ease and Flesch–Kincaid Grade Level to the SSCP Part II patient text using Word’s readability statistics

• Define an acceptance criterion for the Overall Patient section

• Justify exceptions where sub-sections sourced from IFU (warnings/indications/contraindications/risks) cannot be simplified

• Require a glossary of medical and scientific terms when terminology drives grade level above the target

• Report results per SSCP patient sub-section (e.g., identification, intended use, description, risks, clinical evaluation/PMCF, alternatives, training, glossary)

• Document the rationale when any section exceeds the criterion and how mitigation is implemented (glossary placement)

• Conclude whether the patient section is accessible and understandable for patients based on scores and mitigations

This SSCP Readability Validation Report is used when finalizing or updating the SSCP patient-facing content to demonstrate objective, repeatable readability checks.

Key requirements covered include defining Flesch–Kincaid Grade Level (a US school-grade proxy for comprehension effort) and acceptance criterion (the pass/fail threshold supporting consistent decisions).

• Establish an acceptance criterion for the overall patient section

• Run and capture Word Readability Statistics outputs

• Segment scoring by SSCP Part II sub-sections

• Identify IFU-derived text driving complexity

• Add/maintain a glossary to mitigate unavoidable terminology

• Record tables and appendices of scores for traceability

• Conclude pass status and document justification

At Lexqara, we help streamline SSCP patient content, glossary governance, and review workflows, and we integrate readability validation into QMS routines and audit trails. See our Resource Center [https://lexqara.com/resource-center] and PMS & PMCF support [https://lexqara.com/services/pms-pmcf], and consult EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Download the template and request a short gap assessment.