Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745)

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yodon

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#2
#2
Do you have a Quality System certified to ISO 13485 and the MDR? Is your device compliant with the General Safety and Performance Requirements from the MDR (including all the harmonized - or likely to be harmonized standards)?

While compliance to standards isn't exactly mandatory, it is the best path (which you asked for). Realize that Certification Bodies (13485) are way backlogged and so it may take upwards of a year to just get through the certification process. NBs are similarly backlogged due to a sever reduction in the number of NBs and it may take upwards of another year to get CE marked. So if you're in a hurry, you may need to re-think the market.
 
mihzago

mihzago

Trusted Information Resource
#3
#3
Best avenue, and really the only one, would be to find an NB that will work with you to get you the CE cert.
As yodon mentioned, there's a backlog, so it may actually be a year before NB even starts reviewing your application.
 
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