Hi everyone,
I would like to ask a basic question about Notified Bodies and their role.
If I already have a CE certificate issued from a Notified Body, after notifying them about a new product that I want to introduce in the EU market (submitting Technical Files, formulating Declaration of Conformity including it etc...) do I need to wait for their approval to release it, or can I already release that product in the market?
Does this depends on the class of the medical device? (I am interested in class IIa and IIb)
Of course the product falls under the scope of the CE certificate (it is not in a new product category, that is not covered by the CE certificate).
Also, a second question I have about the CE number.
If I have a valid certificate (until September 2021), but the organization cannot be my NB anymore (although the NB is still active), can I still use their CE number on my products until the certificate expires?
Or is the certificate void?
Thanks,
Mark
I would like to ask a basic question about Notified Bodies and their role.
If I already have a CE certificate issued from a Notified Body, after notifying them about a new product that I want to introduce in the EU market (submitting Technical Files, formulating Declaration of Conformity including it etc...) do I need to wait for their approval to release it, or can I already release that product in the market?
Does this depends on the class of the medical device? (I am interested in class IIa and IIb)
Of course the product falls under the scope of the CE certificate (it is not in a new product category, that is not covered by the CE certificate).
Also, a second question I have about the CE number.
If I have a valid certificate (until September 2021), but the organization cannot be my NB anymore (although the NB is still active), can I still use their CE number on my products until the certificate expires?
Or is the certificate void?
Thanks,
Mark