Change of manufacturer address from EU to non-EU after MDR approval

0xwinderstorm

Registered
Hello everyone,

Our company currently is based in Germany and we already signed contract with NB for our portfolio MDR certification with our current address. However, due to recent management changes, we are in the process of planning a relocation to Switzerland, anticipated to occur next year. This relocation is likely to take place only after we have received our MDR certification with the German address.

We are aware that securing an EU Rep is a crucial steps if we move to Switzerland. However, I would like to know if there any additional restrictions or important considerations we should be mindful of when relocating outside the EU while aiming to maintain our MDR certification? Our concern is to avoid the necessity of undergoing another round of certification, considering the associated costs and resource implications.

Your insights and guidance on this matter would be greatly appreciated.

Thanks.
 

Nigel-S

Involved In Discussions
For my two cents, I see you are aware of your Authorized Representative requirement but I would also review your product labeling. The label will now need to indicate the symbol and details of your AR and importers.
 
Top Bottom