MEDICAL DEVICE
Custom-made Medical Device transactions were reflected in the system within the scope of the MDR regulation.
Obtaining a new Custom-made Medical Device registration was blocked under the MDD regulation.
Manufactured MDR bespoke medical device declarations were automatically generated by the system and signed by the responsible manager or signature officer of the company with an e-signature at the device application signing stage.
It was ensured that Class-I other class eligibility statements could be added/updated/applied for without Class-I Other Transaction Authorization registration.
Edits have been made to the free sale certificate template.
It was ensured that the version/model field could be updated for products entered as version/model information “NONE” (case-insensitive) in registered system/process packages.
TITUBB queries have been removed in integration services with the Public Procurement Agency.
It was ensured that MDD Class-I Other Medical Device Transaction Authorization records could be made in bulk with excel template.
It was ensured that at most one technical file could be added to the product.
Has the product been manufactured by its legal manufacturer to another manufacturer of medical devices covered by MDR “? The fields “ and ”Manufacturing institution /company engaged in production" have been opened for updating without application.
cosmetic
The ability to change the responsible person for certificates in the responsible ancestor section has been added to the certificate application depending on the authority.
CLINICAL ENGINEERING
Test, Control and Calibration Organizations have been added the features of Stopping / Starting the Activity.
Technical Service companies have been added the features of Stopping / Starting the Activity.
PGD
A motion recording was created when the file fields were updated.
In the process of linking a file and a report, the requirement has been added that the file owner and the report supervisor must be the same user.
Improvements
MEDICAL DEVICE
In the forms for adding/updating medical devices, the qualification ”Doctor/Dentist“ was given instead of ”Doctor".
It was ensured that the person and message of the sender of the upper confirmation, which is displayed in the temporary record on the documents/devices that have been revised or rejected, can also be displayed in the original document/device transaction history.
The number of characters of the explanations in the transaction history has been increased so that the entire rejection/revision justification message can be displayed.
When a field that could be updated without reference changed in adding a bulk medical device, the update was provided instead of directing the user to the bulk non-reference update.
When the company created and applied for an update notification for the decided document, it was ensured that if an update was requested for the document, the reason for requesting an update was included in the transaction history of the document. In the same way, when the company updated the product for which the update was requested, it was ensured that the history of the document's transaction history related to the update was also included.
CLINICAL ENGINEERING
The Clinical Engineering menu has been updated by grouping the elements.
PGD
Visual improvements were made for the Document Dec Document Number data field contained in the search / query criteria and the add/update forms, which also provides the width appropriate to the current format.
It was ensured that the interrogation criteria were not lost when the details of something were entered and left on all the interrogation pages.
It was ensured that the report type could be updated for some report types (Follow-up, Final, Final (Reportable event) and Final (Event that does not need to be reported)) in the reports returned to draft status.
Fixed Bugs
MEDICAL DEVICE
The error of not being able to select the document start date after October 26, 2021 was fixed when adding an EC certificate with IVD regulation.
Fixed an error in not showing the product name when querying device status.
Fixed the status of returning an incorrect message in the query for dealerships that were canceled in the EKAP dealership inquiry service.
The problem with decision finalization of past period matches for group C SUT code matches has been fixed.
KIK TITUBB Fixed an incorrectly typed expression in the sehven Query Products menu Belonging to the company.
PGD
Fixed a report association failure to access transaction record details when the report type was “New Manufacturer Adverse Event”.
Fixed the issue that the product addition window could not be opened when adding products to a file if the company october in the file is not registered in the system.
Other (Jobs with a “Task" Type)
Various data corrections were made in accordance with the request of TITCK.
At the request of TITCK, various statistics were extracted.
A new list of banned components of cosmetics has been added to the system.
“Periodic Summary Report” and “SKOOR” statistics have been added to the report statistics section of the Medical Device PGD and Warning Statistics page. In addition, detail information was provided for some statistics.
At the request of the SGK, barcode numbers and SUT codes data related to some reference numbers were transmitted.
15 Nov 2021
