Europe’s EN ISO 13485:2016 Out Now – But Another Review Expected In Three Years
This article was originally published in Clinica
Executive Summary
The EU version of ISO 13485:2016, the long-awaited, revised international quality systems standard has now been published. But manufacturers in the EU need to wait until EN ISO 13485:2016 has been “harmonized” before they can use it to claim compliance with the relevant conformity assessment annexes of the medical device directives through the standard.