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EN ISO 13485 FDIS transition date moved to 2019

March 7, 2016

There has been an amendment to the European Foreword to EN ISO 13485:2016 such that the Date of Withdrawal of EN ISO 13485:2012 is now 31 March 2019 instead of 30 September 2016. This is reflected on the CEN website. Click here to be directed to the CEN website.

As this is the version which will be sent to the Commission for harmonization, it is reasonable to assume that this will also be the date of cessation of presumption of conformity of the superseded standard [DOCOPOCOSS], EN ISO 13485:2012.