93/42/EEC Declaration of Conformity and Harmonized Standards

[apuigvert]

Hello all,

Maybe this is a basic question for many of you, but I have a doubt regarding the Standards that should be declared on the Declaration of Conformity according with the MDD 93/42/EEC.

The Situation is, the harmonized standard EN 60601-1:2006/A1:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance will be mandatory since 31/12/2017.

During the recertification Audit, we had some findings relating to this:

The test reports are based on the EN 60601-1:2006/A1:2013, and the collateral standars that are aligned with it were tested (with amendments). For example 60601-1-8:2006/A1:2012, this standard is not harmonized with the amendment and the modifications introduced by A1 imply that the product no longer comply the previous version (harmonized).

The collateral standard with the amendment superseded the harmonized standard. So the question is, can I list the 60601-1-8:2006/A1:2012 on the Declaration of conformity? or only the harmonized standards should be listed?

I hope the explanation is clear, please let me know and I will try to describe again. Thanks a million!!

PD: My thought is that the harmonized standards are voluntary and the manufacturer can choose other standards if he can demonstrate presumption of conformity with the Essential Requirements. So, if the product complies with an improved version of the standard should be good to declare it on the DoC. The thing is that in one of the findings the auditors stated that we declared an ISO standard that is not harmonized - this made me doubt.

 

[Ronen E]

The thing is that in one of the findings the auditors stated that we declared an ISO standard that is not harmonized - this made me doubt.

Did they state it as a NC, or just to highlight that the presumption of conformity does not automatically apply in this case? If the former, you could ask them which clause in the MDD (or otherwise) bans it.

Cheers,
Ronen.

 

[pkost]

If you comply with a standard you can state this on the DoC - it does not have to be harmonised.

You cannot claim compliance with a standard if you have not demonstrated compliance with it (therefore you shouldn't claim compliance with the harmonised standard)


From an approval point of view, its not clear to me whether the product has been approved or not, if not, then you do not have to use a harmonised standard, you have to demonstrate compliance with the essential requirements. To make your life easier you should do a gap analysis between the two versions and use that to demonstrate why you still comply with the ERs....Doing the gap analysis wouldn't enable you to say that you comply with the harmonised version though!

 

[apuigvert]

Hi Ronen! He stated as a NC, so I need a solid rationale to support the DoC.

I already told her that the regulation states that the Standards are voluntary, but this made her position stronger.

 

[apuigvert]

If you comply with a standard you can state this on the DoC - it does not have to be harmonised.

You cannot claim compliance with a standard if you have not demonstrated compliance with it (therefore you shouldn't claim compliance with the harmonised standard)


From an approval point of view, its not clear to me whether the product has been approved or not, if not, then you do not have to use a harmonised standard, you have to demonstrate compliance with the essential requirements. To make your life easier you should do a gap analysis between the two versions and use that to demonstrate why you still comply with the ERs....Doing the gap analysis wouldn't enable you to say that you comply with the harmonised version though!

Hi Pkost,

Thank you, I completely agree with you. My DoC was made that way, declaring the standards that the product complies. This led to a NC, so I need to explain to the auditor why I dont want to change it.

The prduct is not approved yet, this was the recertification audit and we are having the follow up audit next month. The Standards that were tested are a newer version of the Harmonized standards.So we can presume compliance with the ER.

With the GAP analysis done, we should declare the harmonized standard? or the ones on the test reports?

Thanks a million!

 

[Ronen E]

He stated as a NC, so I need a solid rationale to support the DoC.

The auditor needs a solid rationale, and I suspect there isn't one.

I already told her that the regulation states that the Standards are voluntary, but this made her position stronger.

I don't understand how it makes the auditor's position stronger. It is not even closely related to the issue at hand. For that NC to be justified, there has to be a requirement saying that non-harmonized standards are forbidden on the DoC, or at least a requirement that the DoC only contains explicitly listed elements, with only harmonized standards on such a list. None of these is the case. As far as I know, there isn't even a clear requirement to list any applied published standards (harmonized or not) on the DoC. Such listing is required on the Technical Documentation and could be on another document.

The main effect of the DoC is to declare that the MDD requirements that apply to a given device have all been met.

 

[Ronen E]

The Standards that were tested are a newer version of the Harmonized standards.So we can presume compliance with the ER.

This is not generally an acceptable argument. Testing to the newer standard may suffice for satisfying the ER, but "presuming compliance" has a very specific meaning in the MDD context, and that is reserved only to harmonized standards. With a harmonized standard, compliance with the ER is considered automatic (no NB discretion); with any other standard (even a newer version of a harmonized one), the NB will weigh the evidence and decide whether the ER have been in fact satisfied.

With the GAP analysis done, we should declare the harmonized standard? or the ones on the test reports?

The gap analysis is only an aid in justifying that the ER have been met. It doesn't entitle you to claim compliance with a standard that wasn't verified against, even if its requirements are a subset of the ones in the standard that was verified. You should only declare compliance with the standard(s) specified on the test reports.

Cheers,
Ronen.

 

[TWA - not the airline]

This is not generally an acceptable argument. Testing to the newer standard may suffice for satisfying the ER, but "presuming compliance" has a very specific meaning in the MDD context, and that is reserved only to harmonized standards. With a harmonized standard, compliance with the ER is considered automatic (no NB discretion); with any other standard (even a newer version of a harmonized one), the NB will weigh the evidence and decide whether the ER have been in fact satisfied.


The gap analysis is only an aid in justifying the the ER have been met. It doesn't entitle you to claim compliance with a standard that wasn't verified against, even if its requirements are a subset of the ones in the standard that was verified. You should only declare compliance with the standard(s) specified on the test reports.

Cheers,
Ronen.

Right, so if the content of the old (harmonized) standard really is just a part of the revised one, i.e. methods/requirements etc. are really identical between the old and the new revision and there have just been some new ones added, why not use the gap analysis to up-rev the reports to state that testing was performed according to the harmonized standard? Or maybe even according to both? That way the DoC could correctly reference the harmonized standard and no NC anymore...

 

[pkost]

Right, so if the content of the old (harmonized) standard really is just a part of the revised one, i.e. methods/requirements etc. are really identical between the old and the new revision and there have just been some new ones added, why not use the gap analysis to up-rev the reports to state that testing was performed according to the harmonized standard? Or maybe even according to both? That way the DoC could correctly reference the harmonized standard and no NC anymore...

Because it's just not cricket?...It could be done but OP needs to consider what they want to achieve and in what timescales

1. do they want the NC to "go away"?
Either do what the auditor wants (quicker, may lead to problems down the road)
Complain to the NB (slightly longer)

2. do they want to state compliance with the harmonised standard or the newer standard on DoC
if newer standard...just state it and complain to NB in option 1
if the harmonised standard (I do not know the standard so excuse my comment if wrong), it is preferable that the report references it, but with the gap analysis, if it demonstrates that the new standard is tighter and the product is still compliant with the harmonised standard, then I don't know of any reason why you can't claim compliance with the harmonised standard.

e.g. (horendously simplified)
new standard requires result = 5+/-0.1units
harmonised standard requires result = 5 +/-1unit
compliance with new standard automatically infers compliance with harmonised standard


One thing that they MUST do, is demonstrate compliance with the ER's, this would be achieved by conducting a gap analysis between new version and the harmonised standard and justifying how the differences still comply/do not impact compliance with the ERs



Personally (without having any awareness of the business priorities) I would conduct the gap analysis to demonstrate compliance with ERs, reference the new standard on the DoC (because I don't fully agree with referencing a different standard from the one in the report) and tell the auditor to learn the rules, with a request for review of the NC to the NB.

 

[TWA - not the airline]

pkost, I do understand your position and I agree that the OP needs to consider the options before taking actions. From my perspective I am missing some details regarding the NC (there may have been some formal mistake in the documentation that was not adequately explained to the OP) and the objectives of the OP and also I always tend to have my documentation straightforward instead of trying to discuss or argue my case. Even if I am right, it may not help me in the end. So regarding some advice for the OP, I considered it much safer to show the easy and straightforward way that has no risk of overlooking some of the details we may be missing. If all documents of the OPs design control process list the harmonized standard as design input and all documents that show compliance of the design output to the input requirements (reports, requirement traceability matrix, DVV plan or whatever) also reference the harmonized standard down to the list of standards and the DoC then the design dossier is easy and straightforward to review and does not give cause for unnecessary questions, where the answers may or may not be understood by the reviewer.