ISO 14971:2007 vs. 2009 - Which Risk Management Standard is still accepted in the EU

[Nancy Allen]

Hello All,
Can someone advise whether the 2007 version of the risk management standard is still accepted in the EU, or must the 2009 version be used? Is there an easy way to determine what the changes are between the two?
Thanks much for any response.

 

[Marcelo]

Re: ISO 14971:2007 vs. 2009 - Which Risk Management Standard is still accepted in th

Hello Nancy

There´s no 2009 version of ISO 14971 (it´s still 2007).

There´s an EN version which was updated in 2009.

Only the EN version gives presumption of conformity with requirements, and right now only the 2009 version.

You can read more about it here: BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007

The differences from the ISO 2007 version to the EN ISO 2009 version is that the latter has revised Annexes Zs (the ones related to each European medical device directive).


Also, please be aware there will be a 2012 version of EN ISO 14971 published this year an in the future (after it´s harmonized) you will have to comply with that versions if you want to gain presumption of conformity.

 

[Nancy Allen]

Re: ISO 14971:2007 vs. 2009 - Which Risk Management Standard is still accepted in th

Thanks, Marcelo,
We are still using ISO 2007 and I was looking for significant changes which would require us to change. As a Class 1 medical device manufacturer, we self certify, and do not require a notified body.
Nancy