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.
IDENTIFICATION OF DATA SOURCES
A justification for the data collection method shall be made to gather sufficient clinical data for the medical device.
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.
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WHAT CAN WE DO FOR YOU?
MDR Clinical Evaluation Support Including:
- 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
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