CLINICAL EVALUATION OF MEDICAL DEVICES
STAGES IN THE CLINICAL EVALUATION PROCESS
The Clinical Evaluation process has four stages. At the beginning
of the Clinical Evaluation, a plan shall be made including a
scope, a justification for sufficient clinical data, data sources,
and scientifically sound clinical data review protocols.
CLINICAL EVALUATION PLAN
The Clinical Evaluation Plan presents data on the intended
purpose, clinical risk, benefit, outcome and claims, sufficient
clinical evidence and state-of-the-art definition of the medical
devices.
DATA APPRAISAL METHODS
Based on the reliant data, appraisal of the literature, equivalent
device, or clinical research data should be analyzed and reported.
CLINICAL EVALUATION REPORT
Analysis regarding clinical benefits, safety, and undesirable side
effects related to the medical device should be reported. The
report provides evidence of compliance with the General Safety and
Performance Requirements.
SUMMARY OF THE SAFETY AND CLINICAL PERFORMANCE
For Class III and IIb implantable devices, a Clinical Performance
and Safety Summary (SSCP) document shall be uploaded to the
EUDAMED system, The report is performed after Clinical Evaluation
Report.
CLINICAL EVALUATION AND QUALITY MANAGEMENT SYSTEM
Assignment of duties and responsibilities in the Clinical
Evaluation process, the inclusion of source data, the criteria for
data quality, and how the data will be transferred to other
processes in the Quality Management System (QMS) must be
demonstrated in a QMS procedure.
Please visit the following links for more information:
WHAT CAN WE DO FOR YOU?
MDR Clinical Evaluation Support Including:
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Determination of intended purpose [medical indications, if
applicable; 'name of disease or condition/ clinical form,
stage, severity/ symptoms or aspects to be treated, managed or
diagnosed; patient populations; intended users; organs/parts
of the body/tissues or body fluids contacted by the device;
duration of use or contact with the body; repeat applications,
including any restrictions as to the number or duration of
re-applications; contact with mucosal membranes/ invasiveness/
implantation; contraindications; precautions required by the
manufacturer; single-use / reusable; other aspects]', as per
MEDDEV 2.7/1 revision 4,
General device description,
Clinical Evaluation Plan,
-
Identification and appraisal of relevant scientific
literature,
Appraisal of available Clinical Investigations,
-
Review of currently available alternative treatment options,
Medical device lifetime data management,
Benefit/risk assessments,
-
Determination of 'State of the Art' treatments/technologies,
-
Integration of PMS, PMCF, Vigilance System, Risk Management
System and QMS data,
-
Demonstration of conformity with relevant Annex I General
Safety and Performance Requirements,
Processing equivalence claims.
Manufacturer's documentation development and maintenance
including:
-
Clinical Evaluation Plan / Clinical Evaluation Report
-
Summary of Safety and Clinical Performance Plan / Summary of
Safety and Clinical Performance Report
Our latest presentation in cooperation with
TÜMDEF
is available for download
