Module 15 2022

20/05/2022

MDR Requirements relating to CEAR

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 4

3

MDR Requirements relating to CEAR

What is a clinical evaluation assessment report (CEAR)? ● The CEAR is the report documenting the Notified Body’s assessment of a manufacturer’s clinical evaluation (Annex II (4.8), Annex VII (4.6), Annex X (3e)). ● Applies to all Class of devices. ● A CEAR is also produced in case of Article 61(10) assessment. ● The CEAR sets out the Notified Body conclusion on the clinical evidence provided by the manufacturer, in particular: – Benefit-risk determination, – Consistency of that evidence with the intended purpose, including the medical indication or indications , – PMCF plan (Annex XIV, Part B). ● The CEAR is provided to the manufacturer at end of conformity assessment.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 4

4

2