As AdviQual, we held our Clinical Data Evaluation Training on March 31, 2016. We wanted to share with you what we remember from the training. You can also access our trainings by clicking here.
Clinical evaluation according to the definition of MEDDEV 2.7.1 Rev.03; It should include the evaluation and verification of the clinical safety and performance of a medical device during application when it is used in accordance with the intended use specified by the manufacturer.
The components that contribute to the clinical evaluation process can be summarized as follows:
- Risk management
- Global Licensing Strategy
- Product Specifications
- Labeling/User Manual
- Preclinical Studies
- Clinical Trials
- Post-Market Clinical Experiences and Surveillances
- Literature review
The steps of clinical evaluation consist of planning, evaluation and analysis of clinical data. Clinical Evaluation Plan is a document created before the clinical evaluation process and prepared taking into account licensing standards and regulations. The following points should be taken into consideration when preparing the Clinical Evaluation Plan:
- Determining the scope of the report and plan in accordance with the requirements specified in MEDDEV 2.7.1 Rev.3
- Are there any product features or target populations that require special attention regarding the use of the medical device?
- Whether equivalent device data is available to demonstrate the safety and/or performance of the device in question
- Data sources and types to be used in clinical evaluation
The safety and/or performance of a medical device is evaluated based on data from the device itself or its predecessor devices.
The clinical data to be evaluated are briefly summarized below:
- Clinical trial data
- Available scientific literature data on the device itself or equivalent devices
- Post-market clinical experience data
Clinical data are evaluated and graded in terms of qualitative suitability for the use of the device and quantitative contribution of the data (Data Contribution) (MEDDEV 2.7.1 Rev.3 Annex X):
- Level 1: Indicates that the data used belongs to the device itself
- Level 2: Indicates that the data used belongs to an equivalent predecessor device.
- Level 3: Indicates that the data used belongs to a similar device. Literature Review
The literature search strategy should be clearly documented.
- Time interval during which the scan was performed
- Name and surname of the person doing the scanning
- List of databases used
- Boolean Commands Used (AND, OR, NOT)
- Selection criteria
- Exclusion criteria
- Abstract search algorithm
As a result of summarizing the data of each study in the literature review in tables in terms of qualitative suitability and quantitative contribution, it is proven to what extent the data in question contributes to the device.
In each subsequent clinical evaluation update, whether any new device-related risks have emerged based on the literature update and their possible effects on device performance are discussed.
Risk assessment
One of the most important parts of the clinical evaluation of a medical device is risk assessment.
It should also be discussed whether the clinical data require updates to the risk assessment report or user manual.
The risk assessment section concludes with a conclusion as to whether the benefits outweigh the risks, considering the risk-benefit assessment outlined.
Conclusion
Considering the intended use of the device, the results determined by the clinical evaluation are summarized in terms of safety and performance. Whether the results obtained from the study comply with the previously established Essential Requirements; It is declared whether the performance and safety of the device have been proven as claimed before clinical evaluation and whether the potential risks are at an acceptable level compared to the benefits provided by the device for its intended use.
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