UL Listing - Do you find UL Listing necessary? Medical Devices

Dave-h

Involved In Discussions
#1
Dear All,

We are a UK based manufacturer of finished medical devices that we sell around the world, including the USA. Currently the electrical products are UL listed, but this is becoming increasingly expensive.

We are aware that there other bodies that offer a similar service to that provided by UL.

We have been advised that although the FDA don't require UL listing, many insurance companies do insist on their clients having UL (or similar) listing.

We are curious to know if the FDA would expect to see anything in place of a UL type listing (3rd party 60601 certification for example), and is the advice regarding insurance company requirements correct?

Thanks for your help.

Dave
 
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M

MIREGMGR

#2
Re: UL Listing - Do you find it necessary?

It is narrowly true that "the FDA doesn't require UL listing" for medical electrical equipment. However:

If a given device type requires premarket notification or approval and fits into a FDA Product Code for which one of the IEC 60601 "Medical Electrical Equipment" standards is a Recognized Consensus Standard, the FDA does expect that the submitter will have an appropriate conformance stance regarding that standard...either certification/approval/labeling/listing by a Nationally Recognized Testing Laboratory (of which UL is one), or some other acceptable approach.

In addition to that, equipment that must be wired into place, in most US local jurisdictions, must be installed by a licensed electrician who must obtain a permit and have the job inspected. In many such jurisdictions, the inspector will not accept installation of equipment that is not Listed or Labeled by an NRTL such as UL.

Specific requirements probably depend on circumstances, but I would expect an insuror at a minimum to require that equipment to be added to a hospital's existing blanket policy must be regulatorily compliant and legally installed. Thus insurors' requirements might vary from installation to installation, but likely would always include a requirement for NRTL approval of one kind or another.

I know of instances where hospitals will not purchase plug-in or otherwise-portable medical electrical equipment that is not Listed or Labeled by an NRTL. I don't specifically know of that stance resting on either a legal or an insuror requirement, but it could. It also could be based on a conservative conclusion, perhaps driven by the hospital's legal staff, that it may be easier to defend against various tort lawsuits if all of the electrical equipment has third party certification.
 
L

Laughing Pierre

#3
Re: UL Listing - Do you find it necessary?

We have sold loads of medical electrical equipment to the USA. All of it is CE marked and has 510(k)s. All 60601-1 testing is done in house. All 60601-1-2 tetsing is done by an independent test house. None of the equipment has been UL listed. I can recall one establishment refusing to purchase because of this.
 
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M

MikeEmergo - 2010

#5
I would suggest contacting Intertek for a competitive quote. They do the same testing and certifications as UL.

You do need to meet FDA requirements and GMP as well as the testing requirements for safety and efficacy of your medical device. g/l
 
L

Laughing Pierre

#6
Just to reitterate. We have sold hundreds of bits of medical kit to the USA and none is UL listed. All of it is covered by 510(k)s as it MUST be. All of it is CE marked. All of it meets the requirements of 60601 and any other applicable safety standards.

Now comes a cautionary tale. A US company has asked us to develop a variant prodcut under their name. We have CE approval for the device and it is in the final stages of FDA scrutiny for 510(k). Without telling us the US company has also submitted the device to UL!!!!! Enter one shed load of extra work. UL don't let any safety related component part of any device through easily if it does not already have UL approval/certification. So, Dave, if you haven't already spec'ed UL approved mains inlet, mains filters, isolation transformers, opto-isolators, fuses, cables, etc, etc and you decide to go for UL, be prepared for a whole load of design changes and technical justifications and arguments and time and money. Our kit is some of the safest medical electronic equipment that money can buy and all of the safety related components are deliberately over-rated, but if they ain't on the UL list they ain't on the UL list. And that's all there is to it.
 
M

MikeEmergo - 2010

#7
You could try Intertek in addition to UL. They are similar test labs. They will do the same thing UL does (give you testing to UL standards) but you won't get the coveted UL sticker. You do get an ETL sticker and confirmation that it passes (which is what is required by electrical inspectors)

They will take a look at all the parts as a whole, and test and give you 60601 (EMC and Safety) test reports, that is if it passes.

g/l
 
L

Laughing Pierre

#8
Thanks for the tip Mike, but too late in this instance. The US company has already gone too far down the road with UL. They have already had isolation tranformers and opto-couplers disected (literally) and technical reports written and all sorts. I think that we've reached that point where it is cheaper to carry on the current path (excuse the pun) than to involve another entity. As far as the sticker to say we've passed is concerned, we already have one of those - the CE mark. Don't you just love global harmonisation.
 

Dave-h

Involved In Discussions
#9
And of course, in addition to the various design changes and investigations etc, there are of course the UL factory inspections, 4 times per year and unannounced - each inspection takes about half a day and costs around £1200 (we have two UL products).

Thanks for your input chaps.


Dave
 
B

Burgmeister

#10
We have found the UL label invaluable in selling our equipment in the US. Yes, its expensive, Yes it's a shed load of work, No its not a requirement, but in our experience the benefits outweigh the costs. I am surprised that Laughing Pierre hasn't had any problems selling devices in the US without one we certainly did. Many hospitals wouldn't touch the equipment without the magical UL marker. We considered using TUV at one point but that wouldn't sway many a hospital purchaser so we jsut stuck with UL.
 
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