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Refurbishing of Class2a Medical Devices

patmelad

Starting to get Involved
#1
We currently have a CE marked class 2a Medical Device, Reusable, Not Sterile, Never had an incident or recall. This product was introduced to the market in 1992.

From 1992 to 2010 We had VDE approval .
From 2011 until present we have had CE approval This was a slightly different model But all electronics software wiring plastic are identical .Just a slight mechanical difference.

What we are looking to do is Refurbish existing VDE approved older equipment up to the Current Standard For CE , and then reintroduce this equipment back into the market under a new model . The intended use usability risk management of the Refurbished Model is identical to the equipment currently being used that is CE approved .

Is there any clear way to do this or guidelines on how to do this, and probably the most important question is can we do this?

Any insight would be appreciated!!
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#3
...Is there any clear way to do this or guidelines on how to do this, and probably the most important question is can we do this!
In short, you can do this. A couple suggestions, however:

- Treat it like rework (taking non-conforming product, and making it conforming), and hence subject to whatever procedure you have for rework (impact/risk assessment, approved rework instructions/procedure, acceptance criteria, record keeping...).

- You should (must?) disclose that the resulting product is not new. It can be marketed as "refurbished", "restored",whatever...and sold at discount. But to sell the device along with your brand-new inventory could be considered deceptive marketing.
 

patmelad

Starting to get Involved
#4
Thank you Mark for your reply, I just had my surveillance audit for CE and our transition audit for upgrading to 13485:2016. Zero non conformance I am proud to say.
I know that the New MDR 2017/745 Deals much more directly with Refurbished Medical devices. I have already started to pull together a Technical File for the product and being that this is all so new there is not much help to be found on where to start. I am a one man Department here , just trying to find whatever help I can. If you have any other insights on this matter I would be very interested to hear them.
Thanks again
 
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