eudamed - european commission · 2020. 10. 2. · actor registration request correct actor...
TRANSCRIPT
DG Health and Food Safety
Positive outcome
Final refusaloutcome
REQUEST APPROVED
SRN ISSUED
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Notifications are sent to inform actors on the assessment outcome
and the possible action to undertake
EUDAMEDE u r o p e a n d a t a b a s e o n m e d i c a l d e v i c e s
When an economic operator has submitted its actor registration request, the selected relevant national competent authority issues the SRN (generated by EUDAMED) after approving the registration request.
EUDAMED notifies the SRN via email to the economic operator.
Submit
Submit
Corrections requested
Send Actor registration
request
CorrectActor registration
request
AssessActor registration
request
VALIDATION PROCESS AND NOTIFICATIONS W h a t ’ s t h e v a l i d a t i o n p r o c e s s f o r a n E c o n o m i c o p e r a t o r t h a t i s n o t a n o n - E U m a n u f a c t u r e r
t o o b t a i n a n S R N
REQUEST REFUSED
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EU manufacturer, authorised representative, importer and system/procedure pack producer
ACTOR REGISTRATION REQUEST PROCESS FOR ECONOMIC OPERATORS EXCEPT NON-EU MANUFACTURER
To obtain an SRN, economic operators that are not non-EU manufacturers (EU manufacturers, authorised representatives, system/procedure pack producers and importers) must submit an actor registration request in EUDAMED.
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DG Health and Food Safety
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� � � � � � � � � �� � � � � � � � Notifications are sent to inform actors
on the assessment outcome and the possible action to undertake
EUDAMEDE u r o p e a n d a t a b a s e o n m e d i c a l d e v i c e s
When a non-EU manufacturer has submitted its actor registration request, its selected authorised representative verifies the registration request before passing it to the national competent authority for assessment.
The national competent authority responsible for the authorised representative issues the SRN (generated by EUDAMED) after approving the registration request.
EUDAMED notifies the SRN via email to the non-EU manufacturer
Submit
Corrections requested
Positive outcome
Outcome passed to CA
Final refusaloutcome
Send Actor registration
request
CorrectActor registration
request
VerifyActor registration
request
AssessActor registration
request
VALIDATION PROCESS AND NOTIFICATIONS W h a t ’ s t h e v a l i d a t i o n f o r a n o n - E U M a n u f a c t u r e r p r o c e s s t o o b t a i n a n S R N
Submit Submit
REQUEST APPROVED
SRN ISSUED
REQUEST REFUSED
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Non-EU manufacturer
ACTOR REGISTRATION REQUEST PROCESSFOR NON-EU MANUFACTURER
To obtain an SRN, non-EU manufacturers must submit an actor registration request through EUDAMED.