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End of Life or Device transfer regulations for Legal Manufacturer

#1
Is there any regulation around the situation when a legal manufacturer of a medical device (MDD) either discontinues supplying that device or transfers the ownership of the device to another business entity : - warranty , support, labelling . time periods, listing with NB etc
 
#2
Hi Mike,
I can tell you from experience that is a significant difference between end-of-life, which is essentially a commercial decision, and ownership transfer which has regulatory and quality implications that varies from one country to another.
I am not aware of a specific guidance or regulation in the EU surrounding this. Keep in mind that these are business activities/decisions. What needs to be done can be deduced from existing regulation.
You need to be more specific, and you can certainly contact your NB for advice.

Shimon
 
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