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Competent Authority

General topics

Overview of profile hierarchy

Requesting access as a competent authority user

Validating user access requests as a CA

Relevant for: CA (Validator)

Validating actor registration access requests

Validating change of Competent Authority requests

Managing actors and user accounts

Consulting registered actors

Certificates

Search and view refused/withdrawn applications for conformity assessment

Search and View requests for suspension/withdrawal of certificates

View nominated expert list

Search and View CECP

Searching and filtering on all MS summary reports (not only the ones from your DA)

Searching and filtering own MS summary reports

Vigilance

Register a new NCAR

Create Vigilance & Post-Market Surveillance form

Applicable only for NCAR

Manage Vigilance & Post-Market Surveillance reports

Applicable only for NCAR

Delete Vigilance & Post-Market Surveillance draft report

Applicable only for NCAR

Search & View Vigilance & Post-Market Surveillance reports

Applicable only for NCAR

Provide comments to FSNs

Manage a PSR

PSRP assessment - first version

CI/PS

Notifications triggered by the system

Validation process

Authorisation process

Acknowledge receipt (only applicable to PMCF/PMPF notifications)

Accept or reject a pre-existing application/notification

Search and manage application / notification

Market Surveillance part 1

Getting started

Data structure

User profiles

Notifications

Registration of procedure

Register a Final Inspection Report

Register a 4-year MS review

Register an Annual Summary report

Register a measure (and new version) for another CA's procedure

Create a new measure

Manage a procedure

Manage all reports

Measure(s) linked to UNR procedures

Raising objections

Additional information

Market Surveillance part 2

Create new version of a report

Create new version of procedure

Create a new version of a corrective action

Create new version of a measure

Create a new version of additional information

Discard a report

Discard a corrective action

Discard a measure

Discard an objection

Discard additional information

Search & view procedures

Search & view reports

Search & view bulk procedures

Search & view bulk reports