EU Publishes EN ISO 13485:2012

#1
EU Publishes EN ISO 13485:2012

The European standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, has been published, after approval by CEN on January 24, 2012. This replaces EN ISO 13485: 2003, although the text of the global standard ISO 13485:2003 is unchanged, only the foreword and annexes in the European version have been revised. The revised standard will be available in the upcoming weeks.
Note the text of the standard is unchanged. Only the informative (Europe only) annexes ZA, ZB and ZC are changed.

The ISO version remains the 2003 one.
 
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Marcelo

Inactive Registered Visitor
#2
Yes, this version is the output of the discussion on the formal objection to harmonization of ISO 13485.

With this new edition (with the revised annexes) ISO 13485 can remain harmonized.
 
M

Mondo 22

#3
All,

Regarding ISO13485:2012, does this need to be referenced instead of ISO13485:2003?

When does ISO13485:2003 become obsolete?

Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#4
All,

Regarding ISO13485:2012, does this need to be referenced instead of ISO13485:2003?

When does ISO13485:2003 become obsolete?

Thanks
Hi,

First of all, this relates to EN ISO 13485, not ISO 13485.

Second, as far as I understand, EN ISO 13485:2012 was not yet officially harmonized (reference not yet published on the Official Journal). I guess that as soon as that happens, a cessation date for presumption of conformity (=harmonization) for EN ISO 13485:2003 will be published as well. Once that latter date has come and gone, MDD compliance documentation should preferably refer to EN ISO 13485:2012 rather than EN ISO 13485:2003.

Cheers,
Ronen.
 
M

Mondo 22

#6
Hi Ronen,

Thank you for your response.

Is there any indication on when EN ISO13485:2012 will be officialy harmonized?

Thanks,
Ray
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Hi Ronen,

Thank you for your response.

Is there any indication on when EN ISO13485:2012 will be officialy harmonized?

Thanks,
Ray
An email newsletter I got from BSI America a while ago, indicated it may happen around mid-2012. I have no other indications or updates, sorry.
 
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