Wearable Medical Device & Mobile Apps in EU

E

esh14

#1
Hi, I'd like to find out the classification system for a wearable device & mobile apps (or mobile medical apps) based on the EU regulation. Do we have to register them separately?

Thank you.
 
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Ronen E

Problem Solver
Moderator
#2
Hi, I'd like to find out the classification system for a wearable device & mobile apps (or mobile medical apps) based on the EU regulation. Do we have to register them separately?

Thank you.
Hi,

To classify a medical device in the EU you need to follow the classification rules in Annex IX of the MDD (Medical Devices Directive). Regarding your second question, see my response to your similar post in the USA regulation forum.

Cheers,
Ronen.
 
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