February 2024 SOCRA Source Journal - Journal - Page 70
TABLE 7:
COMMON ISSUES RELATED TO CERS IN THE EU
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Not addressing new equivalence requirements
Not establishing the clinical evaluation plan or a performance evaluation plan
Missing supporting documentation, such as post-marketing clinical follow-up data or a safety
and efficacy summary
Lack of sufficient clinical evidence for previously approved products
Not addressing trends
Detailed Notified Body
review guidance
Update frequency
Equivalence (from multiple
aspects)
Documentation, including
plans, protocols, and
methods
Stating when non-European
data can be used
Active periodic updates
according to the risk class
Clinical expertise (the
evaluation team)
Detailed guidance on
information sources for the
literature review
The guidance includes a
template for the structure of
documentation. There is quite
a bit of focus on the level of
evidence. Each clinical trial
needs to be evaluated for the
level of evidence it provides.
A randomized clinical trial is
the most important and most
reliable type of clinical trial.
Key content in MEDDEV
2.7/1 Revision 4 includes the
following:
• A1. Demonstration of
equivalence
• A2. When should additional
clinical investigations be
carried out?
• A5. Literature search and
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literature review protocol,
key elements
A8. Devices for unmet
medical needs—aspects to
consider
A9. Clinical evaluation
report—proposed table of
contents
A12. Activities of notified
bodies
A12.2.2. The report of the
notified body
The clinical evaluation should
be done by a team. MEDDEV
2.7/1 Revision 4 includes
criteria for the qualifications and
knowledge of the main author
and signer of the CER. The main
author must have a degree
and 5 years of experience or,
without a degree, 10 years
of experience. Knowledge
requirements include specialist
clinical expertise on the device
and its application, along with
knowledge of research methods
(including statistics), regulatory
requirements, and medical
writing (including practices of
systematic review).
According to MEDDEV 2.7/1
Revision 4 Section 6.4, the CER
must be an actively evolving
document. It should be
updated:
• any time there is new
SOCRA SOURCE © May 2023
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information from postmarket surveillance,
at least annually for highrisk devices e.g. active
implantable devices and
Class III devices, or
every 2 to 5 years if the
device does not pose
a significant risk or is
well established, with an
appropriate justification.
Table 7 highlights common
issues in the EU related to the
MDR CER, including failure to
address the new equivalence
requirements. This might occur
if equivalence was established
when the product was approved
and the product has not been
critically reassessed for 10 or
15 years. Another common
issue is not establishing a
clinical evaluation plan or a
performance evaluation plan for
a CER for an in vitro diagnostic
device. Lack of documentation
for the process used to
develop the CER is another
common issue. For example, a
standard operating procedure
for disposing of devices is
not sufficient. The device
manufacturer should also have a
protocol as a plan.
Missing supporting
documentation, such as post-