Data structure
Access EUDAMED Market Surveillance (Playground).
Procedure characteristics
Unacceptable Risk (UNR) must include at least one corrective action at submission, linked to one or more Economic Operator(s) (EO) and one or multiple devices.
Measures from the initiating CA should only be registered in EUDAMED after the period has passed for the EO to take adequate corrective actions, when EO did not comply with the requirements.
Other CAs may also add measures and additional information, but they can only object to the initiating CA's measure(s),
Other Non-Compliance (ONC) does not require corrective action(s) and must link to one or multiple EOs and one or multiple devices.
There must be at least one measure linked to the procedure before it can be submitted.
There is no possibility to register objections on measures for ONC.
Preventive Health Protection (PHP) follows the same rules as ONC. The only difference for the device scope type is that the category can be used for preventive health protective measures while for ONB and PHP it is not an option.
Procedure and linked items:
Procedure type | Linked Corrective action(s) – by initiating CA? | Linked Measure(s) – by initiating CA? | Other CA can add Measure? | Other CA can add Additional information? | If linked measure: other CA can object? | EO | Device |
|---|---|---|---|---|---|---|---|
UNR | At least one at submission – cannot be added afterwards | Only when Procedure = Open (i.e. can only be added after submission) | Yes | Yes | Yes, but only within two months of first submission of measure by initiating CA (cannot object to measure by other CA) | =/>1 | =/>1 |
ONC | No | At least one at submission; cannot be added afterwards | No | No | No | =/>1 | =/>1 |
PHP | No | At least one at submission; cannot be added afterwards | No | No | No | =/>1 | =/>1 |
INFOGRAPHIC: MSU procedure processes
Who has access
The main actor in the Market Surveillance (MSU) module is the Competent Authority. CA users must request access to the CA to which they belong.
A slim viewer profile is assigned by default to the MSU users for Vigilance and CI/PS.
A Notified Body (NB) referenced in a procedure is notified once the procedure is submitted, and will have read-only access to the record via the Search & View page.
Economic Operators and Sponsors have no access to the MSU module.
The icon indicates the fields the NB will not view:
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