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Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Software

A

aeropel

#1
Where can I find a Checklist for what exactly is required from my software to be CE mark compliant? (bassed on IEC 62304 I presume)

Thanks a lot
 
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sagai

Quite Involved in Discussions
#2
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

Hello there!
The "checklist" is the MDD itself and the corresponding MEDDEV guidances to be honest.
Here is the link for the MDD:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:en:NOT

IEC/ISO 62304 has no direct connection to CE marking in my view. With other words, compliance with this IEC/ISO 62304 does not allow you in any means to affix the CE mark.
That's my recollection.

Cheers!
 
A

aeropel

#3
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

Hi Sagai,

Thanks for info. I now that 62034 is not enough for CE. In my case - being the software a class IIa device - it requires an NB approval. But the auditors check that the software life cycle respects the harmonized standard that they claim to be the IEC 62034. My understanding is that the software has to meet IEC 60601-1 for the relevant items only. (excluding EMC for example.)
 

sagai

Quite Involved in Discussions
#4
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

There is no "has to" for these standards.
It is purely up to you if you use or not use them.
Cheers!
 
A

aeropel

#5
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

I had to send my technical file for auditing and got a non conformity for USING the IEC 60601-1-4 while I was supposed to use the IEC 62034 as per the auditors....
 

sagai

Quite Involved in Discussions
#6
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

I think unless you determine volunteer compliance to any standard apart from ISO13485 and ISO14971 in your quality policy, all you need to be in place is your view over your compliance with the essential requirements defined in the corresponding MDD.
One angle looks correct from your auditor is that you have nothing to do with IEC 60601 due to that is for electrical programmable devices, whereas your software only device is not that kind.
Cheers!

ps.: if you really keen on this 62304 compliance a food of though would be to list all of the requirements in this standard and next to them list the things you have in place that addresses the particular requirement.
Again, your compliance with essential requirements are the one is required.
 
#7
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

IEC (EN) 60601-1-4 has been superseded.

The requirements from that standard are now covered by IEC 60601-1 Clause 14.

It might seen daft to use 60601-1 for a standalone software project but it is certainly possible.

Remember that 62304 does not cover the validation requirements (which 60601-1 cl.14 does). See the diagram in Annex C of 62304 showing the 'V model'.

And it is Validation that is directly referred to in the Essential Requirements - ER12.1a)... software must be validated according to the state of the art....
 

sagai

Quite Involved in Discussions
#8
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

Pads, you are lighting up a million gallons gasoline tank with referring to this miserable, ambiguous and vague "state of the art" statement. :popcorn:
Cheers! :)
 
A

aeropel

#10
Re: Requirements for Software to be CE Mark Compliant - IEC 62304 Medical Device Soft

So IEC 6060-1 clause 14 is sufficient?
 
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