9. Clinical evidence analysis — GSPRs
Source: CER Template.pdf pages 21-22 (document: Mantra Systems Free CER Template, Edition 2)
The objective of this section is to draw conclusions as to whether the available clinical evidence demonstrates that the device conforms with the relevant GSPRs, is non-inferior to identified objectives, and is suitable for its intended purpose.
This section should reflect the appraisal of evidence presented above, ensuring that quality evidence is presented and that both favourable and unfavourable data is considered.
9.1. Introduction and methodology
State an objective for the analysis section (e.g. to analyse suitability of the device for its intended purpose and GSPR conformity).
9.2. Statement on sufficiency of clinical evidence
Reflect back to requirements on sufficiency of clinical evidence set out in the CEP (and summarised in Section 4 above). Have these requirements been met? Justify conclusions reached.
9.3. GSPR conformity analysis
9.3.1. GSPR 1 - Requirement on suitability for intended purpose
Summarise key findings from the clinical evidence relating to the subject device's suitability for its intended purpose. Highlight strengths and weaknesses in the evidence and comment on consistency. Draw an evidence-based conclusion.
9.3.2. GSPR 1 - Requirement on safety and effectiveness and not compromising clinical condition
Describe to what extent the evidence supports device safety. What parameters have been used? What outcomes have been considered? Provide a justification for conclusions raised.
9.3.3. Performance against safety and performance objectives
Summarise key findings from the clinical evidence relating to the subject device in terms of quantifiable / qualifiable safety and performance parameters. Compare these with safety & performance outcomes from the SOTA review. The comparison should be statistical, where feasible. Remember - the objective is to demonstrate statistical non-inferiority of the subject device UNLESS the manufacturer makes a specific claim of superiority.
This aspect of writing a CER is complex and requires a detailed understanding of suitable methodology. Contact our team for more information or assistance with comparative analysis.
9.4. GSPR Conformity - Conclusion
Write a short summary, outlining whether overall GSPR conformity has or has not been demonstrated.