01Clinical Literature Search Report
A record of the search questions, terms, databases, dates and criteria, with selected publications, objective summaries, appraisal decisions, exclusions and reasons, search-flow counts and limitations.
02Clinical Evaluation Plan (CEP)
A working plan defining the clinical questions, methods, objectives and acceptance criteria, state-of-the-art approach, evidence needs and links to planned follow-up where applicable.
03Clinical Evaluation Report (CER)
A reviewable report draft bringing together device information, clinical evidence, state-of-the-art comparisons, safety and performance results, benefit-risk discussion, references and disclosed evidence gaps.
04Risk Assessment Table
Hazards, harms and risk assessments, with traceable evidence showing how risk controls are implemented and whether they are effective.
05Compliance Matrices
Applicable and non-applicable standards requirements, the justification for each decision and traceable evidence supporting implementation.
06GSPR Checklist
General Safety and Performance Requirements (GSPR), with applicability and non-applicability decisions, justifications and traceable evidence supporting implementation.