RMF Inspection to IEC 60601 ed 3 when Conformity Not Claimed

h689e2NR2ok4mceQ

Starting to get Involved
#1
Sorry, I didn't know how else to word the title...

I recently had a CE audit for a device that has a Part 2 standard not due to transition until later, the date not yet set for publication in the OJEU. I'm still claiming the 2nd edition of 60601-1 gives Presumption of Conformity to the Essential Requirements since the Part 2 standard determines the Transition date.

However, the auditor gave a nonconformity for not considering failure modes listed in the 3rd edition of 60601-1. The auditor's assessment of the risk management documentation, relevant for EN 60601-1:2006 compliance, doesn't seem appropriate at this time to me.

Is this appropriate?

There is a Risk Management program in place to 14971:2009 already and I'm writing an assessment for a transition plan to the third edition for this particular device in all markets. I'm hoping that assessing the regulation and having a plan for future based compliance with the third edition should be enough for that issue. This device has been 510k cleared and on the market in the USA for a while with no significant change so the EU will be driving compliance to the updated standard.

So I'd like to ask if there's something I'm missing? Like I said, I don't think that it's appropriate to assess RM to the third edition for this device right now but could the argument for assessment be that we should consider "state of the art", or something like that?

The Part 2 standard is tentatively scheduled to be published sometime mid-2013 per CENELEC and I'm trying to get some breathing room until we go all-in.

Thanks in advance!
 
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D

drewsky1

#3
This is interesting. Did you recognitize and address the failure modes within your risk management document?
We have several legacy products and understand if there has not been any "significant change" to the device for existing FDA approved devices, it may not require to meet the new standard (3rd ed). Can anyone describe or give an example of what a "significant change" would be? I would think anything that would change the form, fit, or function of the device that may impact safety and effectiveness would apply here and therefore would require a filing. This then would mean testing to new standard would apply.
 

h689e2NR2ok4mceQ

Starting to get Involved
#4
Yes, of course risks are assessed per 14971 and the hazards outlined in the standard are covered. It's just that the hazards aren't itemized, detailed and cross-referenced to the relevant sections between 14971 and the 3rd edition standard in a presentable way to satisfy "Compliance is checked by inspection of the RISK MANAGEMENT FILE" to the auditor, which I believe isn't stated in the 2nd edition.

The device does need a proper assessment to the 3rd edition and I can see the value of more diligent handling of risk management in the standard but we don't expect any major surprises in transition that will make the device inherently less safe. Well, I submitted an assessment and plan to do it properly when it's required so I'll see how it goes.

I can't post links but if you search "ucm134575" you'll find FDA guidance with examples of modifications that may require a new 510(k).

IMO it's always good to refer to FDA guidance when there's change and you'd probably use the 3rd ed. even though the transition is June 30, 2013. I believe Health Canada takes a similar approach for licensed devices but the deadline has already passed. In the EU all devices, new, modified, and current production are expected to have addressed the 3rd edition to remain eligible for CE marking to the MDD, unless it has an applicable Part 2 Standard published.
 
D

drewsky1

#5
This is good to know as we are in process of updating our risk documents and this is exactly how we are structuring it.

I did the search you mentioned here in Elsmar but the only item that comes up is this correspondence.
 
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