eudamed - european commission · 2020. 10. 2. · actor registration request correct actor...

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.