Certification services for ISO 13485, CMDCAS 13485, and CE Markings

WAF64

Starting to get Involved
#11
To my understanding, the CMDCAS is an extension of your existing ISO 13485 certification issued by an european notified body who is also accredited by the Standards Council of Canada (SCC) and which has been recognised by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). So, a certification according to EN ISO 13485 is a pre-requisite to obtain an extension to CMCDAS.
Hope this clarifies the issue, however if you still have doubts you can contact any notified body and ask them, I'm sure they'll be able to anwer all your questions.
 
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sabrina.qa

#12
If they all came from the same audit and you didn't pay extra for the 3rd certificate, why would you care?
One audit contained an observation that we did not have a copy of the 13485:2012 standard (before I joined). I also think handling multiple 13485 certs will get more complicated as we start to grapple with ISO 13485:2016 and MDSAP (which is still based on 13485:2003 IIRC), and that all of this juggling is potentially unnecessary. I'm hoping only having one ISO 13485 would simplify matters.
 
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sabrina.qa

#13
To my understanding, the CMDCAS is an extension of your existing ISO 13485 certification issued by an european notified body who is also accredited by the Standards Council of Canada (SCC) and which has been recognised by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). So, a certification according to EN ISO 13485 is a pre-requisite to obtain an extension to CMCDAS.
Hope this clarifies the issue, however if you still have doubts you can contact any notified body and ask them, I'm sure they'll be able to anwer all your questions.
This is what my question boils down to I would say! Thank you, I will check with an NB.
 
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Sarah Stec

#14
Sorry if I'm about to complicate matters (but here I go anyway)...:notme:

ISO 13485:2003 for CMDCAS is not the same as EN ISO 13485:2012. The CMDR requires ISO 13485:2003, not EN ISO 13485:2012.

You may have two different certificates because your customers require you to be certified to EN ISO 13485:2012. While you can be certified for both (the texts of the standards is the same) EN ISO 13485:2012 relates to the MDD differently than ISO 13485:2003. For some parties, the certification is quite important and you may want to check with your customers to ensure you're not accidentally cutting one of them out by doing away with one of your certificates.
 
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sabrina.qa

#15
Thanks, Sarah.

I am ultimately curious as to what scenarios and which parties would reject the ISO 13485:2003 and insist on the EN ISO 13485:2012. I haven't come across this at all so far and no foreign markets have specified EN ISO 13485:2012 from me yet.
 
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Sarah Stec

#16
I've seen manufacturers reject their subcontractor's ISO 13485:2003 certificates when the subcontractor supplies a service or component of the manufacturer's medical device that bears a CE marking. It depends on what the manufacturer's subcontractor acceptance criteria is.

Regulators outside the EU wouldn't necessarily specify EN ISO 13485:2012, since it's an EU-only harmonized standard.
 

Ronen E

Problem Solver
Staff member
Moderator
#17
Thanks, Sarah.

I am ultimately curious as to what scenarios and which parties would reject the ISO 13485:2003 and insist on the EN ISO 13485:2012. I haven't come across this at all so far and no foreign markets have specified EN ISO 13485:2012 from me yet.
Normally you need an EN ISO 13485:2012 certification for the MDD presumption of conformity. Perhaps some NBs will do with an ISO 13485:2003 certification (as noted above, the normative text is identical), I don't know.
 

WAF64

Starting to get Involved
#18
In Europe you will not get an ISO 13485:2003 certification anymore supporting CE marking, because the harmonised standard is now EN ISO 13485:2012. This is the only standard that gives presumption of conformity to the 93/42 EEC Directive.

The differences with the 2003 version are contained in the new Annex Z.
This is why Sabrina got a non-conformity for not having a copy of the EN ISO 13485 standard.

The standard version that applies in each area (EU or outside) is determined by the country specific medical device regulations.

So for EU it is EN ISO 13485:2012, for Canada it is CSA/ISO 13485:2003.
 

Ronen E

Problem Solver
Staff member
Moderator
#19
In Europe you will not get an ISO 13485:2003 certification anymore supporting CE marking, because the harmonised standard is now EN ISO 13485:2012. This is the only standard that gives presumption of conformity to the 93/42 EEC Directive.

The differences with the 2003 version are contained in the new Annex Z.
This is why Sabrina got a non-conformity for not having a copy of the EN ISO 13485 standard.

The standard version that applies in each area (EU or outside) is determined by the country specific medical device regulations.

So for EU it is EN ISO 13485:2012, for Canada it is CSA/ISO 13485:2003.
I understand your points but I partly disagree.

To get EC certified you don't have to be EN ISO 13485 certified. Harmonized standards are voluntary, and you are at liberty to show compliance with the MDD by alternative means. Since the normative parts of ISO 13485:2003 and EN ISO 13485:2012 are identical, a manufacturer certified to ISO 13485:2003 could argue that they are in compliance with the MDD (based on the fact that compliance with EN ISO 13485:2012 is considered equivalent to compliance with QMS aspects of the MDD). Some NBs might not accept that argument but in my opinion that would be unreasonable and unfair. On the other hand, I think that there are at least a few NBs out there that would accept (and it's not because they're inferior or slack). All this is to say that the EN version is required for presumption of conformity, but presumption of conformity is not the only route for MDD compliance and EC certification.

Annex Z is part of the informal part of the standard. It shows how the standard satisfies MDD requirements, but it's absence doesn't prevent compliance with the MDD.

I don't know why Sabrina got the NC for not having the EN version, I wasn't there and I don't know what argument her company made. If they somewhere claimed compliance with EN ISO 13485 while not having a copy, that could be a reason. However, simply not having it is not a justified cause for a NC because nowhere in the MDD it says that you must have it or comply with it (or any harmonized standard).
 
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