In This eBrief:
Clinical data is at the heart of European Union Medical Device Requirements (EU MDR). The term is linked to extensive discussions regarding EU MDR and regulatory requirements for the demonstration of appropriate clinical data.
Data, definitions and documentation will represent the most significant change in terms of the type, quality, quantity and accessibility of information. While clinical evidence and device descriptions are not new requirements, product classifications are changing, and risk will be the determining factor on the type and quantity of data required to be collected, retained and reported.
Though every device design change can vary from one to the next, there are a few core practices to follow to demonstrate sufficient data. This eBrief provides a brief list of items to consider before embarking on a design change to a medical device planned for distribution to one of the European Union member states.
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