Getting Legacy Device Risk Files Ready for EU MDR / ISO 14971:2019
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Under EU MDR, notified bodies are required to look at every technical documentation file at least once in a five-year period. This is alarming for companies with devices marketed 10+ years ago, for which the tech files haven't been reviewed critically since the early years on the market. The risk files for these devices may be thin, and far from compliant to the EU MDR. As an added complication, in the intervening years the Risk Management Standard ISO-14971:2019 has also gone through a revision. This is the current “State-of-Art” standard referenced for the Risk Management section of the MDR. These changes must also be considered when revising legacy Risk Management Files.