CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE (EN ISO 10993-18) Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractables and leachable) which could disclose biological risk to patients and medical practitioners. Extractables are substances that can be released from…
MDR LABELLING REQUIREMENTS [A] NON-ACTIVE MEDICAL DEVICES Information on the Label Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging and the intended purpose of the device. The name, registered trade name or registered trademark and the address of its…
In the NAMSA’s website, it is stated that the biological safety 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…
Pre-Clinical and Clinical Data Pre-clinical data are the important testing and safety data collected during research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests. Clinical data are used to prove…
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…
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 in order to thoroughly categorise your programme. The importance…
Clinical Evaluation of Equivalent Devices Clinical Evaluation of Equivalent Devices: What extent of data of 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…
Literature search is a systematic thorough search of all types of literature ( eg. Books, peer reviewed articles etc). Structured literature reviews essential for clinical evaluation of medical device. Medical device manufacturers need to plan and execute a dedicated strategy for literature monitoring, triage and analysis, and the results of the analysis must translate into…
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 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…