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IEC 62304 required for CE Marking of Software?

tebusse

Involved In Discussions
#1
Greeting everyone!

I work for a very, very small company that currently manufactures a SaaS PACS system, which was built without any knowledge of IEC 62304.

I'm in the beginning processes of planning for CE marking of the software, however, I'm wondering if it is a requirement that my company complies with IEC 62304? We are ISO 13485 certified and are compliant with ISO 14971.

If compliance with IEC 62304 is not required, what is the justification?

Regards, Tonia
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: IEC 62304 required for CE Marking?

Hi,

EN 62304:2006/AC:2008 (based on IEC 62304:2006) is a harmonised standard, and as such compliance with it will result in presumption of conformity with the relevant Essential Requirements of the MDD, see:

http://www.ceiweb.it/erratacorrige/en-62304-ec.pdf

However, like all harmonised standards, compliance is not mandatory and you may elect to comply with the Essential Requirements utilizing different methods. In such a case, probably expect a rigorous review of such compliance claims, by the NB.

Cheers,
Ronen.
 
L

lamorenita_QA

#3
Re: IEC 62304 required for CE Marking?

Hello, my request for assistance is a little similar to this thread posting, can anyone help with information regarding EEC Directive 93/68/EEC/CE? any information or directions on where to go to obtain information would be helpful.
 

sagai

Quite Involved in Discussions
#4
Re: IEC 62304 required for CE Marking?

Hello there!
If your request is about where to get it, here is the link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:en:HTML
I tend to say all of these legislation for EU are available online, free of charge.

Ronen,
I am a bit skeptical if compliance (or the presumption of such compliance) with the harmonized standard would mean presumption of conformity with all aspects of the legislation. Harmonized standards explicitly saying so.
I do not have the EN version of 62304 but I suspect there is a list of MDD requirements are not covered.

Cheers!



Cheers!
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: IEC 62304 required for CE Marking?

Hello there!
If your request is about where to get it, here is the link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:en:HTML
I tend to say all of these legislation for EU are available online, free of charge.

Ronen,
I am a bit skeptical if compliance (or the presumption of such compliance) with the harmonized standard would mean presumption of conformity with all aspects of the legislation. Harmonized standards explicitly saying so.
I do not have the EN version of 62304 but I suspect there is a list of MDD requirements are not covered.

Cheers!



Cheers!
Hi,

I never said compliance with a harmonised standard addresses all aspects of the legislation. I only referred to "the relevant Essential Requirements". Of course, there are other aspects besides meeting the (applicable) ERs, and obviously any harmonised standard can only provide presumption of conformity with those ERs that are (wholly or partially) covered by its scope.

Fortunately, these days EN standards provide the "Z annexes" that explicitly state the presumption of conformity scope that can be expected for the particular standard. The link I provided is to AC:2008, which amended annex ZZ of EN 62304:2006. The amended annex text includes the following:

...within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directives 93/42/EEC...
I don't know of an official, more detailed list of specific ERs that would be covered under this clause. My reading of the quote above is that EN 62304:2006/AC:2008 covers all the MDD ERs that are deemed "relevant" to this standard's scope. Medical device software in particular is not my expertise, so possibly a more explicit reference exists without me being aware of it :)

Cheers,
Ronen.
 

sagai

Quite Involved in Discussions
#6
I know :bigwave:

Some people may look into harmonized standards like a holy grail and it is not really the case.

Cheers!
 
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