Real World Data and Evidence (RWD/RWE) provide real picture of how the approved or marketed product is used by HCPs and their patients.
Post Market Surveillance, as described in the EU MDR Medical Device Regulation, is a new concept. A manufacturer shall know at all times how his product performs in the field.
Global rollout of EU MDR and other UDI-type of regulations are driving all medical device companies to revisit their labeling processes to ensure they are all compliant across the extended supply chain.
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