This document provides an overview of a clinical evaluation report (CER) that decodes the step-wise approach for compliance. It discusses key regulatory requirements for CERs including author and evaluator qualifications, specific objectives, data update frequency, use of peer-reviewed literature, demonstration of equivalence, access to equivalent device data, risk-benefit analysis, and post-market data links. The document also characterizes CERs as live documents that require regular review and updates incorporating post-market surveillance activities. Finally, it invites the reader to access an online session for more information on authoring a compliant CER.

1. Clinical Evaluation Report
(CER)Decode the Step-wise Approach for Compliance
Date
11th December 2018

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CER- Industry Reception in last 2 years
04
Clinical Data, Evaluation and Evidence - Overview 05
Agenda
PMS Data – Key Input for CER 06
Clinical Evaluation - - Key component for Clinical EvidenceE 07
Key High Lights of MEDDEV 2.7/1 REV 4 08
Clinical Evaluation Report- Key Characteristics
09
Focus points for a “compliant CER” 12
Stage wise approach for CER Authoring 13
Key Impact Elements for CER Projects 14
Requirement of Enablers in CER Projects 20
Next steps 20
Current Challenges 14

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Regulatory Requirements for CER – Key highlights
Qualification of
report authors and
evaluators
Specific and
measurable
objectives for a CER
Frequency of updates
to a CER
Scientific validity of
the data ( peer-
reviewed literature)
More specific
demonstration of
equivalence
Access to data for
equivalent devices
Detailed Risk-Benefit
Analysis
Link between PMS &
PMCF
Requirements for
Clinical Investigation

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Clinical Evaluation Report – Key characteristics
Clinical evaluation is the assessment and analysis of clinical data needed to
verify the clinical safety and performance of your medical device.
Live Document Stand Alone Document
Require regular reviews
and updates through out
the device life cycle
Require updates from
post-market
surveillance activities

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Questions
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the step-wise approach
for CER?
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