What You Will Learn
-
Clinical evaluation report components related to EU MDR and MEDDEV 2.7/1 rev. 4
-
Relationship of CER to MDR 2017/745, MEDDEV 2.7/1 rev. 4, EN ISO 13485:2016, and EN ISO 14971:2012
-
Relationship of clinical evidence to clinical data and clinical evaluation, with examples
-
Five stages of clinical evaluation under MEDDEV 2.7/1 rev. 4 and their role in the product life cycle
-
How clinical data is employed to support device purpose and use
-
Clinical investigation requirements under EU MDR, and rationale for when it is not needed
-
Creating a clinical evaluation plan in compliance with EU MDR and MEDDEV 2.7/1 rev. 4
-
Data collection processes and types, including the use of nonclinical data
-
“State of the art” with linkage to benefit-risk analysis
-
Data analysis using clinical literature as well as safety and performance data
-
Creating a PMCF plan for the CER and integrating postmarket surveillance and benefit-risk analysis
Who Should Attend
This class builds on our foundational EU MDR class and is appropriate for anyone working in regulatory, quality, risk management, or clinical roles with responsibility for creating, reviewing, or auditing CERs. Participants are expected to have some basic knowledge of clinical evaluation reports, risk management, and medical device regulation in Europe.
Number of Days:
3
CEUs:
2.5