February 2024 SOCRA Source Journal - Journal - Page 64
TABLE 1:
OVERVIEW OF THE CER
Objective:
• To demonstrate that the device achieves its intended purpose without exposing users and
patients to further risk
Three key areas of focus:
• Clinical trials
• The literature
• Post-market data
Updated:
• When new information from post-market surveillance is received that has the potential to
affect the CER
• At least annually if the product is significant risk or is not yet well established
• Every 2 to 5 years if the device has no significant risks and is well established
Assessment and analysis of all clinical data about a medical device:
• Direct data:
◦ Clinical trials and investigations
◦ Post-market data
◦ The literature
• Indirect data:
◦ Available information on similar products
Four key aspects:
• Clinical trials
• Equivalence
• Literature
• Post-market surveillance
high-risk classification or is not
yet well established. Otherwise,
the CER must be updated every
2 to 5 years as justified by a riskbased rationale.
Key data for the CER come
from direct and indirect sources.
Direct data sources include
results from clinical trials and
clinical investigations involving
the device, post-market data
(in-house complaints and
adverse events), and clinical
data published in the literature.
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Indirect data sources include all
of the available information on
similar products that is publicly
available.
The CER must include
evaluation and analysis of
both direct and indirect data.
Contribution of such data in
the body of evidence must
be presented in a Clinical or
Performance Evaluation Plan.
Direct data are often the best
source of data, as they are
on the subject device, and
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therefore provide the most
relevant information. Indirect
data could be about similar
products and technologies,
such as from investigatorinitiated clinical trial results that
are published in the literature.
Data sources should consider
four key aspects in a CER:
• Clinical trials
• Equivalence
• Literature
• Post-market surveillance