P
porscheuberalles
I haven't been able to find what I'm looking for in the MDD so I was hoping someone could point me in the right direction. What is the approval process for modifications to a device with a CE mark? Are there criteria for changes that require a new approval vs changes that don't require new approval?
Also, I was wondering if anyone has a recommendation for a Notified Body; preferably one with sensible feedback times.
Also, I was wondering if anyone has a recommendation for a Notified Body; preferably one with sensible feedback times.