What is Biocompatibility? What is Biocompatibility? – “Medical devices that come into direct or indirect contact with the body” are assessed “for the possibility for an unacceptable adverse biological reaction caused by contact of the device’s component materials with the body.” The term Biocompatibility is described for the specific property of material being compatible…
In the NAMSA’s website, it is stated that the biological testing or evaluation is conducted by characterizing medical devices based on nature and duration of body contact, assessing the selection of raw materials used for construction, reviewing the manufacturing processes, identifying minimum biological end-points of concern and evaluating any existing research data available for addressing…
Benefit Risk Analysis: When the overall residual risk remains unacceptable and further risk control is not practicable, then there would be a need for risk-benefit analysis. In a risk-benefit analysis, a manufacturer shall review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk and hence a…
Clinical Evaluation of Standalone Software: Standalone software with a medical purpose is considered an active medical device, according to the EU MDD/MDR and the UK MDR. The danger to the patient and the users determines the classification. You’ll need to examine the appropriate categorization criteria to categorize your programme thoroughly. The importance of computer applications…
Clinical Evaluation of Equivalent Devices What extent of data on medical devices from other manufacturers does needed to demonstrate equivalence? FOR INSTANCE, Annex XIV (3) EU MDR refers to non-implantable devices of risk classes I – IIb. It specifies that manufacturers must provide clear evidence that they have sufficient access to the device’s data with…
A literature search is a systematic thorough search of all types of literature ( eg. Books, peer-reviewed articles, etc). Structured literature reviews are essential for the clinical evaluation of the medical devices. Medical device manufacturers need to plan and execute a dedicated strategy for literature monitoring, triage, and analysis, and the results of the analysis…
The CER should contain all the documents required to prove the safety and performance of the device being evaluated. The three main sections are: Scope of clinical evaluation: This section should include details of the device under evaluation, the technology used, directions for use, precautions etc. Clinical background, current technology and state of the art:…
What is Medical Device Clinical Evaluation CE is a methodologically sound ongoing procedure to collect, appraise and analyze the clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions…