Description:
This Appraisal Plan defines how we rank and grade clinical evidence to support clinical evaluation decisions for a device.

• Apply MDCG 2020-6 ranking to prioritise stronger clinical evidence sources.
• Grade Suitability using D/A/P/R (device, application, patient group, reporting).
• Grade Contribution using T/O/F/S/C (type, outcomes, follow-up, statistical/clinical significance).
• Use Oxford Level of Evidence (LoE) to classify study strength.
• Set Article Quality rules (High/Low/Off-label) based on rank, LoE, and grading.
• Document how appraisal methods apply across PMCF, literature, PMS, and vigilance/recall data.

Use this plan when you need consistent, transparent appraisal of clinical data feeding clinical evaluation, acceptance criteria, and safety and performance conclusions, aligned with MDCG 2020-6.

It establishes objective grading rules across evidence types. Suitability means the data match your device, intended use, and target population; it matters because misaligned data weakens conclusions. Contribution means the study design and outcomes can meaningfully support claims; it matters because it drives evidence weight.

At Lexqara, we implement appraisal workflows, reviewer checklists, and training that connect clinical documentation, PMS, and regulatory strategy. Visit our Resource Center [https://lexqara.com/resource-center/] and Clinical Activities [https://lexqara.com/service/clinical-activities/]. Use MDCG 2020-6 [https://health.ec.europa.eu/system/files/2020-04/mdcg_2020_6_en_0.pdf]. Request a short gap assessment.