Coming Soon - ISO 14971:2019 Harmonization in the EUSep 27, 2021
According to the latest news, a final draft of the ZA and ZB annexes for harmonization of ISO 14971:2019 is currently going through the voting process
ISO 14971, the International Standard for Risk Management of Medical Devices was recently revised in 2019. Since then, there has been a lot of uncertainty about how it will be harmonized with the now active EU-MDR in the European Union. FDA has already recognized ISO 14971:2019 as a consensus standard with an expectation of its implementation by 2022.
In our recent Interactive Q&A session, we talked about this latest development and discussed a few potential gaps that medical device manufacturers may have to address in their risk management process to comply with the EU-MDR. We also talked about other topics of interest such as aligning to IMDRF codes, handling messy and confusing Post-market data and analyzing adverse events reported in clinical literature.
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