EN ISO 14971:2019 was published today. For those wondering, both the ISO and EN versions were going to be published today, but ISO published the ISO version wrongly ahead of time.
EN ISO 14971:2019 was published today
Published in ISO 14971 and Medical Device Risk Management
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Any transition period/ date of adoption proposed/ declared by ANVISA for 14971:2019.
Also do we know which countries would be adopting them and what would be their timelines?
Hi, ANVISA does not provide transition periods for standards. This may happen in related processes, such as the INMETRO certification.
There’s no general “list” of countries that recognize ISO 14971, you would need to verify in each country’s regulatory requirements.