Transferring NRTL (National Recognized Testing Laboratory)

[willgray888]

Hello,

I'm seeking clarification regarding NRTL (National Recognized Testing Laboratory) and CB certification. We are a manufacturer of overhead ceiling track hoists who currently have NRTL (USA and Canada) and CB certification. Due to poor customer service from our existing NRTL, we're wanting to transfer to an alternative.
Is my understanding correct, to transfer NRTL:
- The new NRTL will review the testing certificates and paperwork from the current NRTL.
- They will either accept the certification or may want to perform their own testing if they find gaps.
- If they take on the certification, they would perform the site auditing and change the listing.
- However, they would only take on certification of the product in its current state, and if we wanted to make any changes to the product, the new NRTL would require full recertification testing, not just the change.

We're certified to
IEC 60601-1 - including American and Canadian deviations
IEC 60601-1-6
IEC 60601-1-11

I've talked to several NRTLs and am only starting to understand the full requirements for transferring the listing. I would appreciate any views and opinions from companies that have gone through an NRTL transition and how you structured the transfer.

Thanks in advance

 

[Tidge]

This is interesting! It isn't hard for me to see why "make any change, pay for a full retest" would be the common approach taken by NRTLs: they have a vested interest in making sure their customers don't switch, so this would be a sort of no-compete agreement. I don't have any particular insight here, except that I used to work for a NRTL (not for 60601-1) and one of the less-discussed reasons for having NRTL testing to consensus standards was to limit competition. It's something of a minor miracle that the USA even has the NRTL system, but it has a lot of echoes with other sorts of industries where the government has authority over a limited number of vendors.

If the original NRTL subcontracted out someone else, perhaps the new NRTL also uses that same 3rd party... this is a circumstance when I think there might end up being some savings.

 

[AllTheThings]

I've worked to move products before under non-medical standards.

After moving them to a new NRTL, I have made some product changes, and they have not triggered full re-testing. But those were mainly material and component changes, and a board layout tweak to accommodate EoL parts. Not particularly major changes, and thus no or very little construction review. And again: not medical.

Generally, the NRTLs should accept eachother's reports...They all have to follow the same OSHA+ISO 17065+ISO 17025 rules.

The structuring was fairly straightforward: ask for quotes to adopt the listings, execute, and pay for the site audit.

Myself and I'm sure others would be interested in which NRTL you are moving away from, but I understand completely if you do not wish to share.

 

[Tidge]

The structuring was fairly straightforward: ask for quotes to adopt the listings, execute, and pay for the site audit.

A million-or-so moons ago, this describes what my understanding of how the NRTL I worked for would handle transfers (also not 60601-1 products). I don't recall us 'luring away' any customers from another NRTL, but I wasn't deeply tied to the program office. The small handful of new-to-us-but-already-established manufacturers that I recall each had manufacturing issues... so I can't say that we "forced retests", but each one of them (that I can recall) ended up with failing product, which I think is a reasonable explanation of why they shifted their business away from their original NRTL.

Those new-to-us product failures were the #1 reason I ever interacted with the program office. The program office was never happy when a product failed, but I always got a personal visit when a new client's materials failed.

 

[Peter Selvey]

NRTL marks are private marks in addition to being regulated under OSHA, so they can write the rules as they want. In fact, the regulated NRTL/OSHA scope is limited to the workers in the hospitals and do not cover the patient (one of the CFRs actually states that any parts of a standard that do not apply to workers is not relevant for NRTL scope). That's obviously not well known and in one sense it's reasonable that NRTLs are allows to have a "private" component of the mark can include patients and/or whatever the individual NRTL decides is important. That's the bad news, in sense that NRTLs can kind of make stuff up.

However, they are required to have publicly available rules which would include how design changes are handled for a previously certified product. Just like medical device manufacturers are covered by ISO 13485, there is a standard ISO 17065 for bodies that issue certification marks, whether private or regulated. Clause 4.6 requires the certification body to keep these rules public.

My suspicion is that (a) rules relating to product changes would not differentiate between the history of how a product gets certified (which is often complex and messy), there is a simple rule applies to all certified products, all products should be treated the same; and (b) the sales persons is totally ignorant of these rules or even ISO 17065 for that matter.

In my memory, under the CB scheme, there is rule that reports can only be amended 3 times. From experience I think this makes sense in that cumulative design changes can get messy, and reporting of design changes from the manufacturer isn't always accurate as you might expect. It's a good idea every 5 years or so to take a fresh look and confirm the report is accurate for the currently produced device. However, that process doesn't necessarily mean a complete re-test, it's possible to transfer data from a previous report if that is still considered representative. Where that gets difficult is if the report (or test data) is from a previous agency. So that might be a trigger to say, stuff it, let's just start again. But still, having the old report should assist in preparation of the new report, and save time.

But that rule should only apply to CB scheme reports. For the NRTL mark, it's common that manufacturers have to change parts and design frequently, so it doesn't make sense to have a heavy procedure for each change. The NRTL should have a stand alone short report (not CB related) that assesses the change, updates the component list, and concludes the certification is still valid. Large manufacturers would never let the NRTLs to get away with excessive rules costs for handling changes, regardless of the history.

So it's possible the NRTL sales person is mixing CB and NRTL rules. Anyway, ask the NRTL for the publicly available rules covering changes, not the sales person's take on them.

 

[willgray888]

I've worked to move products before under non-medical standards.

After moving them to a new NRTL, I have made some product changes, and they have not triggered full re-testing. But those were mainly material and component changes, and a board layout tweak to accommodate EoL parts. Not particularly major changes, and thus no or very little construction review. And again: not medical.

Generally, the NRTLs should accept eachother's reports...They all have to follow the same OSHA+ISO 17065+ISO 17025 rules.

The structuring was fairly straightforward: ask for quotes to adopt the listings, execute, and pay for the site audit.

Myself and I'm sure others would be interested in which NRTL you are moving away from, but I understand completely if you do not wish to share.

I've spoken to several NRTLs regarding transferring the listing, with each one giving different opinions
- Eurofins (the NRTL would be MET) said that most customers who transfer their listing will run the new NRTL and the current NRTL side by side and gradually move over the listings one by one, as the CB scheme needs retesting. They implied that when MET reviewed the test reports from our current NRTL, they would likely request further testing, which is likely why they said most customers transfer gradually.
- UL said that most customers just do a straight listing transfer and implied that the NRTL would likely accept the reports from our current NRTL.
- Element said that they wouldn't recommend transferring the listing as they would require a full CB scheme retest when we wanted to make our first change to our products.

We're wanting to move away from an NRTL based in Southern Germany, if you know what I mean. We're a UK based manufacturer and all the medical 60601-1 is based in Germany. We've found communicating with them very difficult; they won't get on a phone call or teams meeting to discuss projects, and even our account manager is terrible and won't help in facilitating communication. We've even had the situation where they have questioned the accuracy of their colleagues' work, stating they won't accept their own test reports from 2022.

 

[willgray888]

NRTL marks are private marks in addition to being regulated under OSHA, so they can write the rules as they want. In fact, the regulated NRTL/OSHA scope is limited to the workers in the hospitals and do not cover the patient (one of the CFRs actually states that any parts of a standard that do not apply to workers is not relevant for NRTL scope). That's obviously not well known and in one sense it's reasonable that NRTLs are allows to have a "private" component of the mark can include patients and/or whatever the individual NRTL decides is important. That's the bad news, in sense that NRTLs can kind of make stuff up.

However, they are required to have publicly available rules which would include how design changes are handled for a previously certified product. Just like medical device manufacturers are covered by ISO 13485, there is a standard ISO 17065 for bodies that issue certification marks, whether private or regulated. Clause 4.6 requires the certification body to keep these rules public.

My suspicion is that (a) rules relating to product changes would not differentiate between the history of how a product gets certified (which is often complex and messy), there is a simple rule applies to all certified products, all products should be treated the same; and (b) the sales persons is totally ignorant of these rules or even ISO 17065 for that matter.

In my memory, under the CB scheme, there is rule that reports can only be amended 3 times. From experience I think this makes sense in that cumulative design changes can get messy, and reporting of design changes from the manufacturer isn't always accurate as you might expect. It's a good idea every 5 years or so to take a fresh look and confirm the report is accurate for the currently produced device. However, that process doesn't necessarily mean a complete re-test, it's possible to transfer data from a previous report if that is still considered representative. Where that gets difficult is if the report (or test data) is from a previous agency. So that might be a trigger to say, stuff it, let's just start again. But still, having the old report should assist in preparation of the new report, and save time.

But that rule should only apply to CB scheme reports. For the NRTL mark, it's common that manufacturers have to change parts and design frequently, so it doesn't make sense to have a heavy procedure for each change. The NRTL should have a stand alone short report (not CB related) that assesses the change, updates the component list, and concludes the certification is still valid. Large manufacturers would never let the NRTLs to get away with excessive rules costs for handling changes, regardless of the history.

So it's possible the NRTL sales person is mixing CB and NRTL rules. Anyway, ask the NRTL for the publicly available rules covering changes, not the sales person's take on them.

Our NRTL-approved product range is quite stable, and we rarely make significant changes; however, we constantly make small changes that we always notify to our NRTL put they've never asked for a retest under the CB scheme but that doesn't surprise me.

Thanks for the advice. I can go back and ask them more detailed questions. It's certainly a big learning curve trying to understand the different requirements under the CB scheme and NRTLs.

 

[AllTheThings]

I've spoken to several NRTLs regarding transferring the listing, with each one giving different opinions

Yeah, they all have their own quirks. You may also reach out to Nemko. At least in the US, they have been very responsive to listing transfers. Element, as the new kid, is probably hungry for the work too. Very small OSHA scope though.

It may come down to follow-up services too: Who has the auditors local to your production?