MDR Medical Device Transactions

1- MDR MEDICAL DEVICE PROCEDURES

This section describes the medical device transactions carried out within the scope of the Medical Devices Regulation (MDR) in the Product Management Module of the Product Tracking System (ÜTS).

1.1 MDR MEDICAL DEVICE DOCUMENT PROCEDURES

To register a new MDR medical device in the Product Tracking System, the device's MDR documents must first be added to the system and then verified by TİTCK (Turkish Medicines and Medical Devices Agency). Adding device documents to the system is called a Document Notification. After completing the document addition process, the company or institution submits a document application. They then attach the document notifications registered in the system to this application and submit the application to TİTCK for review.

• A Document Application must be created in order for the documents added to the system to be checked by TİTCK.

MDR medical device document procedures are carried out through the Document menu (Figure 1) located in the main menu. Using the "List My Documents" link under the Document menu, you can search and view previously notified documents based on criteria; create a new document notification; and update or delete draft document notifications. The document list displays the document and its information (Document Number, Type, Regulation, Status, etc.). Using the "Document Application Procedures" link, you can apply to TİTCK for document notification verification and query existing applications.

1.1.1 Tıbbi Cihaz Belge Sorgulama

Daha önce kaydı gerçekleşmiş belgeleri listelemek için Belge \ Belgelerimi Listele bağlantısına tıklanır. Belge Listele Ekranı (Şekil 2) görüntülenir. Belge Numarası, Belge Türü ve Durum bilgileri girilerek sorgulama yapılabileceği gibi daha fazla kriter girişi yapmak için Daha fazla kriter açılır menüsüne tıklanır. Gerekli kriterler belirtilerek Sorgula düğmesine tıklandığında kriterlere uygun belgeler listelenir. Temizle düğmesine tıklanarak girilmiş kriterler temizlenebilir.

Along with the MDR; EU Certificate (MDR), EU Declaration of Conformity (MDR), SIP Declaration (MDR) documents have been added to the document type; regulation 2017/745 in the regulation drop-down box; basic UDI-DI number; individual identification number fields and Class-I R (reusable surgical instruments) risk class have been added to the risk class.

• The specified document types, regulation 2017/745, basic UDI-DI number; MDR documents can be accessed in queries made with individual identification numbers.

• You can export all documents to Excel using the Export All Documents to Excel button on the List My Documents screen.

  
  

If you select the relevant criteria and click the Query button, the relevant MDR documents are listed. The status of the registered documents is displayed in the Status field after the query.

To access a detailed description of the document's status, click the Document Number field for the relevant document from the record list on the Document List Screen. The Document Information Window appears (Figure 3).

Belgenin durumu ve durumu ile ilgili açıklama bilgileri Belge Bilgileri Pencere’sinde yer alır.

1.1.2 Tıbbi Cihaz MDR Belge Bildirimi İşlemleri

1.1.2.1 Tıbbi Cihaz MDR Belge Ekle

Yeni bir belge bildirimi oluşturmak için ana menüde Belge \ Belgelerimi Listele bağlantısına tıklanır. Belge Listele Ekranı görüntülenir. İlgili ekranda yer alan Belge Ekle düğmesine tıklanır ve Belge Ekle Penceresi (Şekil 4)

görüntülenir.

Data entry fields appear on the screen based on the selection from the Document Type drop-down list. There are three document types included with the MDR: EU Certificate (MDR), EU Declaration of Conformity (MDR), and SIP Declaration (MDR).

The MDR's equivalent of the EC Certificate, which appeared in previous regulations, is the EU Certificate. When you select EU Certificate (MDR) from the Document Type drop-down list, the required information for adding the document appears on the screen (Figure 5). Fill in the fields in accordance with the explanations provided in Table 2.

The MDR's equivalent of the Declaration of Conformity in the old regulations is the EU Declaration of Conformity. When you select EU Declaration of Conformity (MDR) from the Document Type drop-down list, the required information for the document to be added appears on the screen (Figure 6). The fields on the screen are completed in accordance with the explanations provided in Table 2.

The declaration required to create an MDR System Transaction Package registration notification is the SIP Declaration. When SIP Declaration (MDR) is selected from the Document Type drop-down list, the required information for adding the document appears on the screen (Figure 7). The fields on the screen are completed in accordance with the explanations provided in Table 2.

Document information must be accurately completed based on the printed version of the document. In cases where the printed version of the documents added to the System must be sent to TİTCK by mail, the printed version must be consistent with the information in the System.

• Care must be taken to ensure that the selections in the "Related to Regulation" field are accurate and complete. After the added document is approved by TİTCK, the relevant document will be associated with the medical devices, and the System will verify the accuracy of the medical device class information and the relevant regulations.

• The size of the files to be uploaded to the System within the scope of the document and the file extensions allowed are determined by TİTCK.

  
  

1.1.2.1.1 Listing/Adding Basic UDI-DI Information

There are two ways to list previously added Basic UDI-DI information and/or add new Basic UDI-DI information.

From the main menu, click List My Documents \ Add Document under the Document menu. From the Add Document window, click the Select Basic UDI-DI button. The List Basic UDI-DI Selection window appears.

To list Basic UDI-DI information based on specific criteria, enter the Basic UDI-DI information and/or the Issuing Agency criteria and then click the Query button. The query results are displayed based on the criteria.

İlgili ekrandan Temel UDI-DI Ekle düğmesine tıklanır. Temel UDI-DI Ekle Penceresi görüntülenir. Tahsis Kuruluşu seçilir ve Temel UDI-DI bilgisi girilerek Kaydet düğmesine tıklanır.

Alternatively, click the List Basic UDI-DI link under the Definition menu in the main menu. The List Basic UDI-DI window appears.

To list Basic UDI-DI information based on specific criteria, enter the Basic UDI-DI information and/or the Issuing Agency criteria and then click the Query button. The query results are displayed based on the criteria.

To add a new Basic UDI-DI information, click the Add Basic UDI-DI button from the List Basic UDI-DI window. The Add Basic UDI-DI window appears. Select the Issuing Agency, enter the Basic UDI-DI information, and click the Save button.

After filling in all the information in the Add Document Window, clicking the Add button will save the document's status as Draft and list it on the List Document Screen.

1.1.2.2 Update Medical Device MDR Documents

To list previously registered documents, click the Documents \ List My Documents link. The List Documents screen appears. After querying based on the required criteria, click the Document Number field for the relevant document. The Document Information window appears.

When approved documents are associated with a medical device, the relevant medical device information can be accessed from the Connected Devices tab in the Document Information window. The System Processing Packages to which the devices linked to the document are connected can be accessed from the Connected Devices SIPs tab. After a document notification is created and the relevant notification is submitted to TİTCK by creating an application, all transactions performed on the document are recorded in the Document History tab.

To update document notification information, click the Update button to update the relevant fields.

• All fields can be updated in records with a Document Status of Draft, In Review (Update Requested).

• Document notifications can be deleted for records with a Draft status. An Update Notification must be created to update documents that have been decided.

To create an update notification, click the Create Update Notification button in the Document Information Window. The steps for creating an update notification are the same as those described for adding a document.

• If an update notification is generated for a document in registered status, the document will be moved to Draft status. A Document Application must be created for the document to be re-evaluated by TİTCK. To create a document application, go to the Medical Device MDR Document Application Procedures section.

• In order for an update notification to be generated for a document with deleted status, TİTCK must have issued a decision for all devices connected to the document. Otherwise, an update notification cannot be generated.

A company can categorize all documents uploaded to the system into groups if desired. To do this, click the "Set Document Group" button located below the Document Information Window to display the "Set Document Group" window. From the "Set Document Group" window, you can select from pre-defined document groups, if available. If selected, you can update the selected document group by clicking the "Update" button while selecting it, or you can add a new document group.

To delete a document in the "Saved" status, click the "Delete" button in the "Document Information Window." The document will change from the "Saved" status to "Deleted."

• If there is a medical device related to the deleted document, the relevant medical devices are deactivated by the System.

• For EU Certificate (MDR), EU Declaration of Conformity (MDR), and SİP Declaration (MDR) applications, TİTCK requests updates and informs companies within the scope of documents with the status "Under Review (Update Requested)".

• If the "Can it be added to a new product?" field in these documents is "Yes", a new product record can be created using this document; otherwise, it cannot be added to newly added products.

1.1.3 Medical Device MDR Document Application Procedures

To view registered document applications and create a new one, click the Document \ Document Application Procedures link from the main menu. The List Document Application screen appears.

The List Document Application screen displays previously created document applications. You can query by entering the Document Number and Transaction Tracking Number, or click the More Criteria drop-down menu to enter more criteria. After specifying the required criteria and clicking the Query button, document applications that meet the criteria are listed.

To access a description of the document's application information, click the Application Number field for the relevant application from the application list on the List Document Application screen. The Document Application Details window appears (Figure 24). The review status of the documents within the application can be viewed under the "Reviewed Documents" and "Unreviewed Documents" tabs. If the application has been approved but not signed (Awaiting Signature), it can be signed by clicking the "Signature" button in the Document Application Details window. It can be deleted by clicking the "Delete" button.

Sistem'e eklenen belge bildirimlerine yönelik belge başvurusu oluşturularak belgelerin Sistem üzerinden TİTCK’ya gönderilmesi gerekmektedir. Yeni bir belge başvurusu eklemek için ilgili ekranda Belge Başvurusu Oluştur

Click the button to display the Create Document Application window.

After selecting the Application Type, click the Select Document button. The Select Document to Attach to the Document Application window appears.

The document notifications displayed in the Select Document to Attach to the Document Application window are listed according to the selected Application Type. For example, if Application Type: Requiring Physical Documents is selected, document drafts of the following types are displayed: EC Certificate, Declaration of Conformity, EU Declaration of Conformity (MDR), and SIP Declaration (MDR). Multiple documents can be attached to an application.

• Applications for documents that require physical documentation (EC Certificate, Declaration of Conformity; EU Certificate (MDR), EU Declaration of Conformity (MDR), SIP Declaration (MDR)) and applications for documents that do not require physical documentation must be submitted to TİTCK as separate applications.

• MDR Documents (EU Certificate (MDR), EU Declaration of Conformity (MDR), SIP Declaration (MDR)) and other regulatory documents must be submitted to TİTCK as separate applications. If documents from both regulations are selected and the OK button is clicked in the Select Document to Attach to the Document Application window, the error shown in the figure will occur.

After selecting the documents to be added to the application, click the OK button. The added documents will appear in the Create Document Application window. If desired, you can remove the application by clicking the Remove button on the relevant document.

After verifying the information, click the Create Application button. The Document Application Summary window will appear.

After verifying the documents in the Document Application Summary window, click the Approve button. Approval is completed by signing them with an e-signature by an authorized company user.

• Once the medical device document application creation process is approved, the document registration notifications in the System are added to the application. Once signed, it is forwarded to TİTCK for review. After this step, the application and the documents within the System cannot be updated. If not signed, the document application can be updated and deleted.

• Once the document application is signed and submitted for review, a transaction tracking number will appear on the screen. For the application to be considered, the transaction tracking number must be included on the printed document. The transaction tracking number can also be accessed from the List Document Application screen.

  
  

1.2 MDR MEDICAL DEVICE REGISTRATION PROCEDURES

Medical devices whose documents have been uploaded to the Product Tracking System and verified by TİTCK can be registered in the System. To register medical devices in the System, first add a medical device and create a Medical Device Application. A medical device application cannot be verified by TİTCK without creating a Document Application. After completing the document-adding procedures, the company or institution creates a medical device application and adds devices in the System Application Ready status to this application and submits the application to TİTCK for evaluation.

Medical device registration procedures can be completed via the Medical Devices menu (Figure 32) in the main menu. The "List My Medical Devices" link under the Medical Devices menu allows you to list previously registered medical devices that have been verified by TİTCK. The "Medical Device Application Procedures" link allows you to query existing applications, create a new medical device application, and update or delete draft medical device applications.

1.2.1 MDR Medical Device Inquiry

To list previously registered medical devices, select the Medical Devices \ List My Medical Devices action, and the List My Medical Devices screen (Figure 33) appears. You can enter the Primary Product Number, Brand Name, and Version/Model information to query. Click the More Criteria drop-down menu to enter more criteria. After specifying the required criteria and clicking the Query button, documents that meet the criteria will be listed. You can clear the entered criteria by clicking the Clear button.

With the MDR, Regulation 2017/745 has been added to the regulation drop-down box, which appears when you click the More Criteria link. The basic UDI-DI number has been added, and the Class-I R (reusable surgical instruments) class has been added to the class drop-down box.

• According to regulation 2017/745, medical devices added within the scope of MDR can be accessed by queries made with the basic UDI-DI number.

• You can export to Excel using the Export to Excel () button on the List My Medical Devices screen.

If you select the relevant criteria and click the Query button, the medical devices added to the relevant MDR are listed. The status of the registered medical devices is displayed in the Status field after the query.

To access a detailed description of the medical device's status, click the Primary Product Number field in the registration list on the List My Medical Devices screen. The Medical Device Information window appears.

The status and description of the medical device's status are displayed in the Medical Device Information window. You can print the Medical Device Information by clicking the Print button in the window, or download it as a report by clicking the Download button.

1.2.2 MDR Medical Device Notification Procedures

To create a new medical device notification, select the Medical Device \ List My Medical Devices action from the main menu, and the List My Medical Devices screen will appear.

1.2.2.1 Add MDR Medical Device

MDR medical devices can be added individually or in bulk. To add medical devices individually, proceed to the Add to MDR section. To add medical devices in bulk, proceed to the MDR Bulk Operations section.

1.2.2.1.1 Add to MDR Section

This section will explain the process for adding an MDR medical device to the MDR section.

1.2.2.1.1.1 MDR Medical Device

To add a new medical device, click the Add to MDR section button on the List My Medical Devices screen (Figure 35). When you select MDR Medical Device Connection from the drop-down list, the required information for adding an MDR medical device will appear on the screen.

Medical device notifications that are not ready for application are recorded as "Draft," while medical device notifications marked as "Ready for Application" are recorded as "Ready for Application." If you perform a query by selecting Regulation 2017/745 from the Regulation drop-down box, which appears when you click the Primary Product Number or More criteria link on the "List My Medical Devices" screen, you can access medical devices added under the MDR. The result of the relevant medical device query is displayed.

1.2.2.1.2 MDR Bulk Transactions

Medical devices can also be added to the system in bulk.

1.2.2.1.2.1 Add Bulk MDR Medical Devices

Click the "Add Bulk MDR Medical Device" link from the "Bulk Transactions" button on the "List My Medical Devices" screen, and the "Add/Update Bulk MDR Medical Devices" window will appear.

To add bulk medical devices, click the Download Template Excel File link in the Bulk MDR Medical Device Add/Update window, and add the relevant medical devices to the downloaded Excel file. The completed Excel file, along with the other added files, is then selected from the relevant field in the Zip File format by clicking the Select File button and uploaded to the Zip File field.

• File information should be edited according to the information displayed in the Bulk MDR Medical Device Add/Update Window.

• Once Excel is uploaded to the System, all medical device information in the document is automatically reflected in the System, provided there are no problems with the file formats.

• The size of the zip file that can be uploaded to the Bulk MDR Medical Device Add/Update Window cannot exceed 200 MB.

• Companies can update their products without creating an application. To update a medical device without an application, please visit the "MDR Medical Device Update" section. Additionally, bulk updates without an application can be made by clicking the "Bulk Application-Free Product Update" link under the "Bulk Actions" button. For related information, please visit the "Bulk Application-Free Product Update" section.

• When you click on the Download Template Excel File link, additional fields within the scope of MDR are added to the downloaded file.

1.2.2.1.2.2 Batch Update Products Without Application

To update the fields that can be updated without application in batch operations, click the Batch Update Products Without Application link from the Bulk Operations button on the List My Medical Devices screen. This will display the Batch Update Products Without Application window.

To update products without application in bulk, click the Download Excel Template File link in the Batch Update Products Without Application window and enter the relevant medical device information into the downloaded Excel file. The completed Excel file is then selected in the Zip File format by clicking the Select File button and uploaded to the Zip File field.

• File information should be edited according to the information displayed in the Bulk Application-Free Product Update Window.

• Once Excel is uploaded to the System, all medical device information in the document is automatically reflected in the System, provided there are no problems with the file formats.

• The size of the zip file that can be uploaded in the Bulk Application-Free Product Update Window cannot exceed 200 MB.

• When you click on the Download Template Excel File link, additional fields within the scope of MDR are added to the downloaded file.

1.2.2.2 Update Medical Devices Under the MDR

This section covers the procedures for updating medical devices under the MDR, including updating medical devices added under the MDR and creating an update notification for the MDR transition of medical devices added under other regulations.

1.2.2.2.1 Update MDR Medical Devices

To update MDR medical devices, click on the Primary Product Number of the medical device on the List My Medical Devices screen to display the Medical Device Information Window.

You can update the information of medical devices in Draft or Ready for Application status by clicking the Update button directly.

To update medical devices with a decision, you must create an Update Notification. This is provided in the Medical Device Information Window for the registered medical device.

To create an update notification, click the Update button in the Medical Device Information window and then click the Create Update Notification link. The Update Medical Device Window appears.

The steps for an update notification are the same as those for adding a medical device.

During the update, fields that are not suitable for updating by the UDI (Unique Device Identifier) are not allowed to be changed. This is because updating these fields requires a change in the product barcode. After the update notification is created, an application must be created via ÜTS and submitted to TİTCK.

• If an update notification is created for a medical device that has already been decided, a new medical device registration will be created in Draft or Ready for Application status, depending on the answer to the question "Is the medical device Ready for Application?" A Medical Device Application must be created for the medical device to be re-evaluated by TİTCK. To create a medical device application, go to the MDR Medical Device Application Procedures section. Once the update notification is approved by TİTCK, the medical device will be registered, and the fields in the update notification will be transferred to the device.

To update a medical device without an application, click the Update button and then click the Update Without Application link. The Update Without Application Medical Device window appears.

For updates without an application, you can update the country of origin information, Product Catalog-type documents related to the medical device under the Selected Product Catalogs heading, SUT match status, and whether it will be sold in the healthcare market fields. If "Yes" is selected in the "Will be sold in the healthcare market" field, product images must be added in accordance with product visual standards. The selections for these fields are the same as those described in the medical device addition notification.

• In order for an update notification to be generated for a document with deleted status, TİTCK must have issued a decision for all devices connected to the document. Otherwise, an update notification cannot be generated.

• Medical device notifications with a notification status of Draft or Ready for Application can be updated, copied, or deleted by clicking the More actions button.

On the Medical Device Information screen, clicking the "Copy" link from the "Other Actions" button displays the MDR Medical Device Copy window.

The fields in the "Copy MDR Medical Device" window are the same as those in the "Add MDR Medical Device" window. After completing the relevant fields appropriately, click the "Save" button. If you select "No" in the "Ready for Application" question, the MDR Medical Device is added as a Draft. If you select "Yes," the MDR Medical Device is added as an "Application Ready" status.

1.2.2.2.2 Create an Update Notification for MDR Transition

Medical devices added under the 93/42/EEC and 90/385/EEC regulations, if they have been transferred to the MDR with the same barcode number, can be transferred to the MDR by creating an Update Notification. To enable the MDR transition of medical devices whose MDR transition has already been decided upon, click the Primary Product Number on the "List My Medical Devices" screen to display the Medical Device Information window.

To create an update notification to transition to the MDR, click the Update button in the Medical Device Information window and then click the Create Update Notification for MDR Transition link. The Create Update Notification for MDR Transition window appears.

The fields in the Create Update Notification for MDR Transition window are the same as those for the MDR Medical Device Addition window. The fields for the device approved under the old regulation are transferred here. Other missing fields required for the MDR must also be completed.

The steps for the update notification are the same as those described for the medical device addition notification.

During the update, changes to fields that are not suitable for updating by the UDI (Unique Device Identifier) are not permitted. This is because updating these fields requires a change in the product barcode. After creating the update notification, an application must be created via ÜTS and submitted to TİTCK.

• If an update notification is created for a medical device that has already been decided upon for MDR transition, a new medical device registration will be created in Draft or Ready for Application status, depending on the answer to the question "Is the medical device Ready for Application?" A Medical Device Application must be created for the medical device to be re-evaluated by TİTCK. To create a medical device application, go to the MDR Medical Device Application Procedures section. Once the update notification is approved by TİTCK, the medical device will be registered, and the fields in the update notification will be transferred to the device.

1.2.3 MDR Medical Device Application Procedures

To view registered medical device applications and create a new one, click the Medical Device \ Medical Device Application Procedures link. The List Medical Device Application screen appears.

The List Medical Device Application screen displays previously created medical device applications. You can query by entering the Application Number and Transaction Tracking Number, or click the More Criteria dropdown menu to enter more criteria. After specifying the required criteria, click the Query button to list medical device applications that meet the criteria.

To access information about medical device applications, click the Application Number field for the relevant application from the application list on the List Medical Device Application screen. The Medical Device Application Details window appears. The review status of the medical devices included in the application can be viewed under the "Reviewed Devices" and "Not Reviewed Devices" tabs.

The status of the application can be monitored on the Medical Device Application List Screen.

Medical device notifications added to the system must be submitted to TİTCK (Turkish Medical Devices and Health Administration) through the system to be reviewed. To do this, a medical device application must be created. To add a new medical device application, click the Create Medical Device Application button. From the drop-down list, select an Optical Products Application, Active Implantable Devices Application, Class 3 Products Application, or Other Products Application, depending on the MDR medical device information.

After selecting the Medical Device Application type, the Medical Device Application Summary Window appears.

Click the Select Declaration of Conformity/EU Declaration of Conformity button. The Select Declaration of Conformity for the Device Application window appears. After selecting the Declaration of Conformity, the Products for which the application will be made appear.

If the Declaration of Conformity is visible on the relevant screen, select the checkbox (☐) and click OK. If it is not visible in the list on the relevant screen, enter it in the Document No. text box by selecting one of the filters: contains, starts with…, ends with…, and matches. The default filter is "starts with…". Click the Query button.

Select the checkbox (☐) for the desired declaration of conformity and click OK.

• A single declaration of conformity can be selected in the "Select Declaration of Conformity for Device Application" window. Products subject to the declaration of conformity are submitted in the application.

• Declarations of conformity can be exported to Excel by clicking on the icon if desired.

After selecting the declaration of conformity and clicking the OK button, the Medical Device Application Summary will be listed in the Selected Declaration field. Declarations listed in the Selected Declaration field can be removed by clicking the Remove button.

Click the Select Product button to select the products for which the medical device application will be submitted. The Select Device window for the Device Application will appear.

• The Medical Device Application Summary Window will display all notifications created and with a status of "Ready for Application." If you do not wish to include a medical device in the application, click the Primary Product Number link for the relevant document, click the Update button, and mark the "Ready for Application?" question as "No."

If the medical devices you wish to add are visible on the screen, check the box (☐) and click OK. If they are not visible on the screen, enter the Primary Product Number and/or select one of the following filters: Brand Name, Version/Model, Starting with …, Ending with …, and Matching. The default filter is "Starting with …." Click the Query button.

Check the box (☐) for the medical devices you wish to select and click OK.

• If desired, the medical device list can be exported to Excel by clicking on the icon.

Once approved by TİTCK, the fields in the update notification will be transferred to the registered device.

Once the application is submitted to TİTCK, its status will be listed as Under Review on the Medical Device Application List Screen.