February 2024 SOCRA Source Journal - Journal - Page 68
TABLE 5:
POST-MARKET DATA
Data on the device and similar devices:
• Adverse events
• In-house complaint data
• Post-market clinical trials
• Recall databases
• Device registries
Post market surveillance event summaries:
• Subject device and equivalent/similar devices:
◦ In-house and externally available data
• Details:
◦ Descriptions of the nature of events
◦ Geography and patient impact
• Trends, rates, and risk assessment:
◦ Compare in-house to external post-market data
◦ Be careful with assumptions!
Considerations:
• Regulatory actions
• Include all incidents:
◦ Complaints
◦ Adverse events
• Address rates and trends
• Risk assessment
• Update statistics
to disclose all regulatory
actions. All known complaints
and adverse events must be
included.
Regulators now have access
to analytics, so device
manufacturers must address
rates and trends. For example,
in total knee implants, if a trend
shows that revision surgery is
happening more often than
expected at year 8, this should
be disclosed and analyzed. The
risk assessment and statistics
must be updated.
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PREPARING A CER IN THREE
KEY REGIONS
When preparing a CER, there
are specific nuances in the EU,
Australia, and China that must
be considered. It is hoped that
the requirements of these three
regions will be representative
of how to achieve global
compliance in preparing and
maintaining the CER.
In the EU, the clinical evaluation
is based upon a comprehensive
analysis of available pre- and
post-market clinical data that
are relevant to the intended use
SOCRA SOURCE © May 2023
of the subject device, including
clinical performance data and
safety data. This includes data
specific to the subject device
as well as any data relating to
devices that the manufacturer
claims are equivalent (MEDDEV
2.7/1 Revision 4 Clause 6.3.
How is a clinical evaluation
performed?).
In Australia, the manufacturer
of a medical device must have
clinical data in the form of either
or both clinical investigation
data and/or a literature review
(Therapeutic Goods [Medical
Devices] Regulations 2002,
Item 8.3[1], Part 8, Schedule 3).
In China, clinical evaluation of
medical devices refers to the
process where the applicant or
filing entity validates whether
the products under registration
can meet their intended use
and indications based upon the
information in the literature,
clinical experience data, and
clinical trials (Provisions for
Medical Device Registration:
Decree No. 4 of China Food
and Drug Administration).
PREPARING A CER FOR THE
EU
In the EU MDR and IVDR,
the requirements have been
significantly enhanced not only
for the CER but also for ancillary
documents. Table 6 highlights
key MDR requirements. A CER
is required for every device,
irrespective of class. Practically,
CERs can be grouped by
types (GMDM codes) and
product families, rather than
preparing and updating a
CER for every class of device.
Direct clinical data is required
for active implantable medical
devices and Class III devices.
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