Harmonization of ISO 13485:2016

[shimonv]

Hi Fellows,
I looked this morning on the list of EU MDD harmonised standards and could not see ISO 13485:2016. Can someone explain this and advise when will ISO 13485:2016 become "state of the art" in the European Union.

Thanks,
Shimon

 

[shimonv]

Okay, I think I got my answer.

EN ISO 13485:2016 is ISO 13485:2016 plus three annexes. The EN version has been submitted to the European Commission for harmonisation to the European Medical Device and In Vitro Diagnostic Directives. I guess its just a formal process while the cessation of EN ISO 13485:2012 is still scheduled for March 2019.

Shimon

P.S. I do not like to bureaucratic nature of the European regulatory system. They keep on piling requirements and expect the notified bodies and manufactures to get along with them.

 

[Mark Meer]

...
EN ISO 13485:2016 is ISO 13485:2016 plus three annexes. The EN version has been submitted to the European Commission for harmonisation to the European Medical Device and In Vitro Diagnostic Directives. I guess its just a formal process while the cessation of EN ISO 13485:2012 is still scheduled for March 2019.

That is correct. EN ISO 13485:2016 states the following:

(European Foreword) "This document supersedes EN ISO 13485:2012"
(Endorsement Notice) "The text of ISO 13485:2016 has been approved by CEN as EN ISO 13485:2016 without any modification"

As for it not being on the harmonized standards list yet, we always aim for the latest version, and justify to our NB that it reflects the "state of the art" as required by directives.

P.S. I do not like to bureaucratic nature of the European regulatory system. They keep on piling requirements and expect the notified bodies and manufactures to get along with them.

Not limited to the European system... but, ya, I hear you.

 

[xcanals_tecno-med.es]

The ISO 13485:2016 + /AC:2016 are harmonized for the 3 EU directives


directive 93/42/EEC medical devices
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:016:0008:0036:EN:PDF

directive 90/385/EEC active implantable medical devices
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:016:0001:0007:EN:PDF

directive 98/79/EC in vitro diagnostics medical devices
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:016:0037:0040:EN:PDF

the timeline is 31 mars 2019



regards

Xavier Canals