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…
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…