All hail the Goddess of Search. March 2019 per

https://standards.cen.eu/dyn/www/fp=204:110:0::::FSP_PROJECT,FSP_ORG_ID:37957,581003&cs=10ED77AEC2D379A0A511B4BB99F861487

Brian


From: Stephen Whalen [mailto:[email protected]] 
Sent: Wednesday, January 18, 2017 7:17 AM
To: [email protected]
Subject: [PSES] ISO 13485-2016

All,
I am helping a client with medical device manufacturing QMS.  ISO 13485 - 2016 
has been released however 2016 version is not listed as harmonized with EU.  
Does anyone know if 2016 version is acceptable now for CE approval?
https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

Regards,
Stephen

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