Production vs Repair of Reusable Medical Devices (Class IIa)

MDD_QNA

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#1
Do we make any difference between production and reparation of reusable medical devices (class IIa) from a regulatory perspective?
Can anyone point me to guidelines and advice me on how you have solved the issue with reparation of products from a regulatory perspective? Is it even regulated or is this something that quality department has to take care off?
 
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MDD_QNA

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#3
Re: Production vs Reparation of Reusable Medical Devices (Class IIa)

Thanks Rob! The document was basic, easy to read and says:

14. Spare parts
Spare parts, supplied for the replacement of existing components of a medical device that has already been CE marked are not usually considered to be medical devices unless they are likely to significantly change the characteristics or performance of the finished device. If this is the case then such spare parts are likely to be considered to be medical devices in their own right.
15. Repairs
Where a device is ‘repaired’ and returned to its original owner after the repair the components used in the repair would not require CE marking as medical devices and the repaired device will not require CE marking a second time. The device is not being ‘placed on the market’ but returned to its owner.

So this tells me that it is not regulated other than what comes out of 13485 processes for repair and service.
I'm new to this company and I have never worked with reparation and service, within regulatory and neither have these people and they have been here for 5-6 years and expect me to solve all their problems.

So, we are the legal manufacturer and we have a contract manufacturer. But we are responsible for releasing the product to the market. The kind of reparation that is being done is sometimes in the PCB card of the device, sometimes exchanging one of the LEDs of the lamp and then new testing needs to be done before releasing the product to the market. But since they do not have a process for that, I don't think they re-test the lamp. They just send it back to the customer....
 

MDD_QNA

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#4
Re: Production vs Reparation of Reusable Medical Devices (Class IIa)

Come on, with so many members here there must be someone who can help!!! Or know!!! :magic:
 

shimonv

Trusted Information Resource
#5
Re: Production vs Reparation of Reusable Medical Devices (Class IIa)

Hi MDD_QNA,
To my knowledge there is no specific regulation for reparation of reusable medical devices, but it must pose a challenge from quality prospective on how to do a final inspection for such device.
Can you leverage methods from final inspections of similar new devices that you do? or final inspection from the original DMR for the device in question?

In essence you need support from engineering in terms of assent of change, backward compatibility, risk assessment, reliability engineering.

You cannot release to the market a device without final inspection.

Hope this helps.


-Shimon
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Production vs Reparation of Reusable Medical Devices (Class IIa)

Sorry, somehow this thread has evaded me...

You made a good delineation between regulatory and quality. I understand that you're interested mainly in regulatory so I'll skip quality assurance, although as hinted earlier there are some QA aspects that have to be sorted.

Another thing to note is that the regulatory answer will be territory-specific. Up till now the EU approach was discussed. Unfortunately the FDA approach to repairs is less clear-cut, but practically you can treat repairs on the USA market as de-facto non-regulated by FDA (it has been this way for years). Do note please that the FDA has recently started the ball rolling on tying up the loose ends regarding repair (what they call "recondition"), remanufacturing and the like.

As a general approach to EU regulation of repairs I'll second the above - as long as you're not changing the device original spec and it returns to the original owner, you're not placing a device on the market and you don't need to refresh the CE marking clearance. In that sense it's important to verify that the device spec has indeed not changed, hence the need for final inspection (apart from the QA/QC aspect).

Whether you do the repair in-house or outsource it to your CM doesn't matter from a regultory perspective, because you were, and are staying, the legal manufacturer. Of course all CM / purchasing controls that applied during initial manufacturing would still need to apply, to keep regulatory compliance watertight, if the CM conducts the actual repair. If you originally did the final inspection and release it would make the most sense (and simplify things from a regulatory perspective) that you do it after the repair as well.

HTH
Ronen.

PS Please also note that repair / service has a Post-Marketing Surveillance (PMS) aspect in the EU. It is an important collection channel of information about your device performance, reliability, safety etc. There's quite a lot of good guidance on EU PMS requirements and expectations, you will easily find it on the web if needed.
 
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MDD_QNA

Involved In Discussions
#7
Thank you shimonv and Ronen!
That was what I suspected and wanted the confirmation on that there were no regulation concerning repairs.

And thanks for clearing things out for me! :agree1:
As a general approach to EU regulation of repairs I'll second the above - as long as you're not changing the device original spec and it returns to the original owner, you're not placing a device on the market and you don't need to refresh the CE marking clearance. In that sense it's important to verify that the device spec has indeed not changed, hence the need for final inspection (apart from the QA/QC aspect).

I have in every meeting pushed it to the quality department and they don't want to take the ball. We have a good vigilance department, so the PMS activities are taken care of.
I have read a good document from NBOG about refurbishing that gave me some hints on repair and servicing as well.
 
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