How to adapt to an ISO/EN/EN ISO standard

shruti_hiregange

Involved In Discussions
#1
I have been looking to do some checks if there have been any newer editions released for the applicable standards followed by our company.
I need some guidance in understanding which adaptation of standards needs to be affirmed.
For example: As per ISO website the current edition of ISO 14971 is ISO14971:2007.
But the current CEN adaptation of the same has gone till EN ISO 14971:2012?
My company has CE marked products as well, so does it mean that we have to demonstrate compliance only with "EN" standards?:confused:
Please consider if I have made any errors as I am still a novice in understanding these details.
Thanks. :)
 
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phloQS

#3
Hi,

To fullfill the essential requirements of the MDD it is easier to follow the harmonized standards (find them here). Otherwise you always have to do a gap analysis between the standards. The Za annexes of these standards are very helpful to find the connection to the MDD as well.

regards

phloQS
 

shruti_hiregange

Involved In Discussions
#4
Hi,

To fullfill the essential requirements of the MDD it is easier to follow the harmonized standards (find them here). Otherwise you always have to do a gap analysis between the standards. The Za annexes of these standards are very helpful to find the connection to the MDD as well.

regards

phloQS
Hey,
Thanks for the link!
Annex ZA defines the relationship between the European standard and essential requirements of 93/42/EEC. So I am of the understanding that if we are following the ISO adaptation and then I need to do a GAP analysis to establish gap between harmonized standard and the ISO adaptation.
However the annex doesn't state their relationship.
Also, does the NB put any restrictions on following any particular adaptation? I ask this since I happen to read somewhere in some thread that EU did raise an objection on ISO14971. "It was deemed inadequate because it did not sufficiently cover important essential requirements of the applicable medical device directives."
If someone could provide me a few tips on how such a GAP analysis is done..it would be very helpful.
Thanks! :)
 
P

phloQS

#5
You are right: As I wrote Za annexes just refer to the MDD and not to the IOS standard.
The gap analysis is done by comparing the texts of both standards. There are requiremenst in it and if there are differences you have to adress them adequately.
I do not know the ISO 14971 since we are a european medical devices manufacturer and follow the EN standard. As I told you before using the EN standards is much easier. If there is something important (for MDD) is missing in the risk managemet process of the ISO 14971 you have to add the missing things to comply with the essentail requirements anyway.

regards

phloQS
 
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