Hi
,
We are a small North American manufacturer of Class-2a and 2b devices for Europe. Our devices fall under MDD 93/42/EEC. We have a notified body. Our authorized representative for Europe is based in France.
If there is an adverse event that requires to be reported or an FSCA that need to be initiated under MEDDEV 2.12-Rev:8 criteria, whom all should we report/communicate about the event/actions?
Since the MDVR is currently electronic, which is also known as eMDVR. I am curious to know, how the system works? I understand that a manufacturer's eMDVR will be received by the Notified Body upon its submission. How about the Competent Authorities? Do we need to send the reports to them separately? If so, is it electronic as well? if not, what is the mode of communication?
I understand the present hierarchy like this:
(Manufacturer→AR→NB→MDCG→CA→NCA→Commission)
Your response shall be highly appreciated...
Good day !
SK
, We are a small North American manufacturer of Class-2a and 2b devices for Europe. Our devices fall under MDD 93/42/EEC. We have a notified body. Our authorized representative for Europe is based in France.
If there is an adverse event that requires to be reported or an FSCA that need to be initiated under MEDDEV 2.12-Rev:8 criteria, whom all should we report/communicate about the event/actions?
Since the MDVR is currently electronic, which is also known as eMDVR. I am curious to know, how the system works? I understand that a manufacturer's eMDVR will be received by the Notified Body upon its submission. How about the Competent Authorities? Do we need to send the reports to them separately? If so, is it electronic as well? if not, what is the mode of communication?
I understand the present hierarchy like this:
(Manufacturer→AR→NB→MDCG→CA→NCA→Commission)
Your response shall be highly appreciated...

Good day !
SK