Module 15 2022

19/05/2022

The clinical evaluation report - CER

MDR Annex XIV 4: “The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device”

● Contains the results of the clinical evaluation ● Contains the clinical evidence ● Must consider favourable and unfavourable data ● Forms part of the technical documentation

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

39

The clinical evaluation report - CER

Typical Content of a CER: ● Scope ● Description of the devices ● Results of the searches and identification of any internal clinical data

● Results of selection and appraisal process ● Equivalence Assessment (if applicable) ● State of the art ● Analysis of the data ● Determination of the benefit /risk ratio ● Conclusions

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

40

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