The necessity and benefit of ISO13485:2016 for a manufacturer of class I devices

JP12345

Starting to get Involved
#1
Hello!

We are a manufacturer of class I and class IIa devices who currently holds ISO 13485:2016 certification. We are a small company (30 employees) and we are certainly feeling the burden of increasing regulatory demands (EU MDR, Brexit changes to UK regulations, MDSAP etc). We recently had to give up our efforts to gain MDSAP certification due to the cost and resource involved. Without the Canadian market our class IIa sales are not necessarily justifying the regulatory expense. It has got me thinking about whether, if we dropped the class IIa products and only sold class I devices whether keeping our 13485 certification (and the hassle/cost of annual audits) is worthwhile? I wondered if anybody had been faced with this dilemma before and what the pros and cons are. I understand that the EU MDR requires that the manufacturer has a QMS but does not specify 13485.

We do sell our class I devices all over the world and I know ISO 13485 is valuable to aid registration in other countries, as well as when we are manufacturing for others. Are there any countries that require 13485 for registration of class I devices?

I would welcome any insight :)
 
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LUFAN

Involved In Discussions
#2
I think it all depends on your desired regulatory market and jurisdiction. Just out of curiosity, which company's did you contact for an MDSAP quote? I've found that MDSAP is roughly 3x 13485 only cost with one AO. Tough pill to swallow if you're selling into Canada only, but it becomes worth it with 3-5 countries.

The only thing I'd mention is that when FDA finally does align with 13485, I am not sure what their intention for compliance vs certification will be since they are an MDSAP participant. I know there's a few countries that required 13485 certification, but I believe majority simply require compliance.
 

JP12345

Starting to get Involved
#3
Hi @LUFAN thank you for your reply. Our quote for MDSAP was from NSAI. We did consider the adoption of MDSAP by the other countries but we are not selling the IIa product in to those countries so it didn't seem to make it more worthwhile. Do you know if FDA will require a MDSAP audit for only class I? We are only selling class I into the USA at the moment, thanks!
 

LUFAN

Involved In Discussions
#4
Hi @LUFAN thank you for your reply. Our quote for MDSAP was from NSAI. We did consider the adoption of MDSAP by the other countries but we are not selling the IIa product in to those countries so it didn't seem to make it more worthwhile. Do you know if FDA will require a MDSAP audit for only class I? We are only selling class I into the USA at the moment, thanks!
There has been no talk about the future of MDSAP by FDA. FDA has been talking about formally aligning with 13485 forever, but it's still being dangled out there like a dog chasing a wiener. However, in the past two weeks several articles have been published which indicate FDA's commitment to alignment. I cannot imagine FDA in the near future will require MDSAP like Canada so from that regard, I think you're safe. However, FDA may come to a day where they don't want to bear the cost of routine inspections anymore and put it on the manufacturers and of which case the requirements related to MDSAP and FDA may change.

With all of that that said, your company should ask yourself if not being subject to a routine FDA inspection is worth the MDSAP cost only. Some company's might say yes, some might so no. I would mention to you that in my experience I have found Intertek to have been the lowest of MDSAP providers, but mileage will vary of course.
 
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