4. Clinical evaluation plan — Summary

Source: CER Template.pdf pages 11-13 (document: Mantra Systems Free CER Template, Edition 2)

This section should provide an overview of the Clinical Evaluation Plan for the subject device. A separate (full) Clinical Evaluation Plan needs to be completed and submitted as part of the Clinical Evaluation.

4.1 General Safety & Performance Requirements (GSPRs)

Identify and list the General Safety and Performance Requirements (GSPRs) that relate to the subject device. Get further advice on how to identify GSPRs.

List non-relevant GSPRs and provide a justification for each.

4.2 Type of evaluation

Will the evaluation follow the literature route, equivalence route, route under MDR Article 61(10), or some other route? Specify here.

4.3 Methods used for examining clinical safety

Give a specification of methods that will be used for examining both qualitative and quantitative aspects of clinical safety of the device. This could include a thorough and objective systematic literature review.

4.4 Search protocol: evidence identification, appraisal and analysis plan

A full search protocol must be documented, setting out a plan for the identification, appraisal and analysis of clinical evidence relating to the subject device (and equivalent device, if relevant).

Specifically, the search protocol must outline a plan for:

• identifying clinical evidence
• performing an appraisal of identified data sources / evidence
• analysing appraised evidence

Consider that clinical evidence must include both independent evidence and that produced by the manufacturer.

4.4.1 Level of clinical evidence sufficient to support conformity

"Level of evidence" relates to an assessment of the strength of individual evidence sources and to the overall strength of the entire body of evidence relating to a device. Accordingly,

it is necessary to consider and state the level of evidence required to support conformity, in terms of quality, quantity, and other relevant parameters.

4.4.2 Identifying clinical evidence

How will clinical evidence be identified? What databases will be searched, and how can this be justified?

Remember that each excluded source will need to be recorded and justified.

4.4.3 Appraising clinical evidence

Appraisal determines the value of the identified data and its potential contribution to the evaluation.

Appraisal needs to be objective, systematic and unbiased. Document an appraisal plan that describes the procedure and criteria used for the appraisal.

The plan should include:

• Criteria for determining the methodological quality and the scientific validity of each data source
• Criteria that determine the relevance of each data source to the clinical evaluation
• Criteria for weighting the contribution of each source to the overall clinical evaluation.

4.4.4 Analysing clinical evidence

Analysis is to determine whether the appraised clinical evidence collectively demonstrates conformity with the relevant GSPRs, suitability for intended purpose, and a favourable benefit-risk profile for the device. An analysis plan should be documented in this section.

4.5 Clinical development plan

Where possible, document an overview of a clinical development plan for the device, indicating progression through the following stages:

• Pre-clinical investigations
• First-in-man studies
• Feasibility or pilot studies
• Confirmatory investigations
• Pivotal clinical investigations
• PMCF

This is essential for devices that are new to market; it is less relevant for more established devices and can be omitted for legacy devices with an extensive market (and clinical evidence) history.