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…