C
c1991209384
Both of these standards are for "graphic symbols of medical device label". And most of the symbols are identical. What standard should be used in CE technical file ?
ISO 15223 or EN 980 - What standard should be used in CE technical file?
Elsmar Forum Sponsor
R
Roland Cooke
Al is probably correct, however I believe only the EN980 is actually harmonised under the MDD/IVDD, in the event of any differences.
W
wrodnigg
Yes, only EN 980 is harmonized with the directives.
But: if it is reasonable, a manufacturer can even design his own symbols for the label, as long as they are described in the instructions for use.
Conclusion: you do not need to explain the symbols from the harmonized standard EN 980 in the instructions for use, but all others.
~ghw
But: if it is reasonable, a manufacturer can even design his own symbols for the label, as long as they are described in the instructions for use.
Conclusion: you do not need to explain the symbols from the harmonized standard EN 980 in the instructions for use, but all others.
~ghw
T
thaly7 - 2010
Re: Iso 15223 Or En 980?? What standard should be used in CE technical file?
Hello,
Can anyone tell me if there were any updates to the EN 980 since the May 2008 version?
Any input is appreciated.
Thanks for your time.
Ft. Lauderdale, Fl
Hello,
Can anyone tell me if there were any updates to the EN 980 since the May 2008 version?
Any input is appreciated.
Thanks for your time.
Ft. Lauderdale, Fl
Re: Iso 15223 Or En 980?? What standard should be used in CE technical file?
The latest is EN 980:2008 itself!
I got a doubt, after reading this posting...
Is it mandatory to show conformance to ALL APPLICABLE (harmonised) standards in the CE technical file?
Or what ever standards, we use, just mention in the technical file and show evidence of conformance for those standards.
Say, for eg, for software, if we don't use EN 62304 standard, wil it be a non-conformance during Notified Body's audit?
All thoughts are appreciated!
Regards
Sreenu
The latest is EN 980:2008 itself!
I got a doubt, after reading this posting...
Is it mandatory to show conformance to ALL APPLICABLE (harmonised) standards in the CE technical file?
Or what ever standards, we use, just mention in the technical file and show evidence of conformance for those standards.
Say, for eg, for software, if we don't use EN 62304 standard, wil it be a non-conformance during Notified Body's audit?
All thoughts are appreciated!
Regards
Sreenu
Re: Iso 15223 Or En 980?? What standard should be used in CE technical file?
Dear Sreenu
Yes, it is mandatory to show whatever the standards you use (with respect to your product) in your CE technical file. If any standards are revised, which you already listed in your technical file, you need to revise your list of applicable harmonized standards and also provide proper justification through ECO/ECN. for eg, the new revised standard will not change the previous version requirement it is only the changes in addition of annexure and so on but it will not applicable to our product/process.
Regards
S. Subramaniam
Dear Sreenu
Yes, it is mandatory to show whatever the standards you use (with respect to your product) in your CE technical file. If any standards are revised, which you already listed in your technical file, you need to revise your list of applicable harmonized standards and also provide proper justification through ECO/ECN. for eg, the new revised standard will not change the previous version requirement it is only the changes in addition of annexure and so on but it will not applicable to our product/process.
Regards
S. Subramaniam
Last edited:
R
Roland Cooke
Re: Iso 15223 Or En 980?? What standard should be used in CE technical file?
Under the MDD, there is no absolute requirement to meet any standard, harmonised or not. However some standards are less voluntary than others, and this applies especially to harmonized standards, which are considered to be 'state of the art'.
Thus you will be expected to meet any applicable harmonized standards, or provide a very strong justification as to why not. If you don't, you can expect to receive a non-conformity when the auditor uses the harmonized standard as an audit tool.
Note that the non-conformity wouldn't be against the standard, rather, it would be against Annex I (failing to meet the state of the art).
For non-harmonized standards, the same principles apply, although it can sometimes be a little harder for the auditor to make the case.
Under the MDD, there is no absolute requirement to meet any standard, harmonised or not. However some standards are less voluntary than others, and this applies especially to harmonized standards, which are considered to be 'state of the art'.
Thus you will be expected to meet any applicable harmonized standards, or provide a very strong justification as to why not. If you don't, you can expect to receive a non-conformity when the auditor uses the harmonized standard as an audit tool.
Note that the non-conformity wouldn't be against the standard, rather, it would be against Annex I (failing to meet the state of the art).
For non-harmonized standards, the same principles apply, although it can sometimes be a little harder for the auditor to make the case.
Re: Iso 15223 Or En 980?? What standard should be used in CE technical file?
Hi Sreenu,
As already stated, the MDD does not mandate the use of harmonized standards. You are required to meet the essential requirements, and using a harmonized standard may sometimes be a simple and convenient way of doing so. Indeed, I agree that auditors will sometimes be more pedantic when you don't declare compliance with a harmonized standard, but I don't think this alone will establish basis for a NC.
Additionally, not all NB audit in a similar manner, some are more strict than others, and of course not all auditors are alike
Please note that in some specific cases specific standards (usually device-specific or application-specific) are either mandated by legislation other than MDD, or well-established as "industry-standard" and therefore failure to comply may be quite difficult to justify.
Cheers,
Ronen.
Hi Sreenu,
As already stated, the MDD does not mandate the use of harmonized standards. You are required to meet the essential requirements, and using a harmonized standard may sometimes be a simple and convenient way of doing so. Indeed, I agree that auditors will sometimes be more pedantic when you don't declare compliance with a harmonized standard, but I don't think this alone will establish basis for a NC.
Additionally, not all NB audit in a similar manner, some are more strict than others, and of course not all auditors are alike
Please note that in some specific cases specific standards (usually device-specific or application-specific) are either mandated by legislation other than MDD, or well-established as "industry-standard" and therefore failure to comply may be quite difficult to justify.
Cheers,
Ronen.
S
stephania59
Re: ISO 15223 or EN 980?? What standard should be used in CE technical file?
We have Class III devices in the EU and use both in our technical file, along with BS EN 1041
We have Class III devices in the EU and use both in our technical file, along with BS EN 1041
Last edited by a moderator:
Similar threads
