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!!
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!!