MDR Document Management#

With this functionality, you can organize in a document management system (DMS) the Medical Device Regulation (MDR) documents that should be linked to Microsoft Dynamics 365 Business Central¹ master records. The feature separates storage and assignment in a way that you can file and open MDR documents in the DMS but link each of them to multiple records in medtec365.

For every link set up between an external document and a header or a line in the app, another MDR document entry will be created—even if setup would allow for more than one entry to be assigned to the same part of a master record. You can, however, have different entries linked to different lines on the record.

When you create follow-on documents, such as posted sales documents, the entries will be linked to them as well. They will also be assigned, for example, to item ledger entries when you post journals for a production order.

By contrast, when you simulate the creation of MDR document entries, you see every entry that could theoretically be created according to setup—regardless of whether it will result in an actual entry later.

Setup#

MDR conversions#

To set up conversions for master records:

1. Choose the Search icon, enter MDR Conversion List, and then choose the related link.
2. On the ribbon, choose New.
3. Fill in the fields as described in the following table.

General#

Lines#

Conversion process#

An item is only converted if the conversion date specified for it is the same as or earlier than the work date.

You can convert items by running the relevant function from the ribbon or have them converted automatically by adding the task to the job queue. If you convert manually, you can set a filter on the Item No. field.

If the conversion is carried out by the NAS via the job queue, a dialog box isn’t shown and all certified items are converted at once.

Manual#

To start conversion manually:

1. Choose the Search icon, enter Convert MDR Item from MDD, and then choose the related link.
2. Use the Assist button next to the Item No. field to select an item from the list.

You can set any type of filter value in the Item No. field, including <>ITEM_0422, >A and ITEM_0422|ITEM _0509. In the latter example, ITEM_0422 and ITEM _0509 will be converted. If the Item No. field on the request page is left blank, every item in the Certified status and with a conversion date smaller than or equal to the current date will be converted.

If you specify an item number that is stored in the system but that isn’t certified, that includes a later conversion date, or that no record exists for in conversion setup, you see an error message and the process is canceled.

At the time of certification, no Old MDD Field Value exists on the lines, as the field is filled in during conversion with a value from the item card.

When you choose OK to start the conversion, you’re asked to confirm your choice. If you don’t choose OK again here, the process will be canceled altogether.

If conversion fails, the conversion status is automatically set to Error. You then see a message in the Error Text field. In the same vein, you’re also notified if conversion is successful, with the status set to Converted and the Converted By and Converted On/At fields filled in. The old MDD field values are also entered on the lines and a message appears, stating how many items have been converted.

The new values can then be found on the item card according to conversion setup.

Job Queue#

For values that you want converted automatically with the help of the job queue, you must set up an entry in the queue for codeunit 71076791 (MDR Job Queue Handler) with the ‘convert mdd to mdr’ string.

When the queue is run, the system then converts all certified records that include a conversion date on or before the work date. If the process is successful, the values on the conversion cards are updated in the same way as during manual conversion.

If processing encounters an error, the status of the conversion record is set to Error and the Error Text field is filled in. The system then continues with the next item that needs to be converted.

Item#

You can use the Check Approval Reqs. Field, found on the Misc. FastTab in the item master, to specify whether the system should check for approval requirements in an MDR context (where they’re called ‘authorizations’).

medtec365 Setup#

To set up DMS integration for MDR documents:

1. Choose the Search icon, enter medtec365 Setup, and then choose the related link.
2. On the DMS Integration FastTab, fill in the fields as described in the following table.

MDR DMS Structure Setup#

Here you can specify the areas, groups, and names required for the structure of the DMS. To specify the structure:

1. Choose the Search icon, enter MDR DMS Structure Setup, and then choose the related link.
2. Fill in the fields as described in the following table.

MDR DMS Document Types#

On this page, you can specify the document types that will be used in the DMS.

1. Choose the Search icon, enter MDR DMS Document Types, and then choose the related link.
2. On the ribbon, choose New.
3. Fill in the fields as described in the following table.

MDR DMS Document Control#

Here you can specify the conditions that must be met for the system to create the entries that link Microsoft Dynamics 365 Business Central¹ to MDR documents.

1. Choose the Search icon, enter MDR DMS Document Control, and then choose the related link.
2. On the ribbon, choose New.
3. Fill in the fields as described in the following table.

Documents#

On this FastTab, you can turn on one or more of the following toggles to specify the types of documents that document control should apply to:

• Sales Quotes
• Sales Orders
• Blanket Sales Orders
• Sales Invoices
• Posted Shipments
• Posted Sales Invoices
• Purch. Quotes
• Purch. Orders
• Blanket Purch. Orders
• Purch. Invoices
• Prod. Orders
• Subcontract Orders
• Assembly Orders
• Repairs

Alternatively, you can use the Select All action on the Options FastTab to turn on the toggles for all documents listed. Select None will cancel the current selection.

Document Type Details#

This FastTab shows the description, area, group, and name of a document type. For more information, use the lookups available for the fields on the tab.

MDR DMS Document List#

To see the list of current MDR DMS documents or create a new document:

1. Choose the Search icon, enter MDR DMS Document List, and then choose the related link.
2. To create a new document, choose New on the ribbon and fill in the fields as described in the following table.

General#

Assignment#

Home: Ribbon Functions#

Set to Certified

Sets the document to Certified. Only certified records are included in the DMS but cannot be edited (except for their assignment lines) and cannot be deleted.

With the status set to Certified, the compliance process for MDR documents will be started after you enter a compliance message (provided the functionality is set up).

You will also see an error message if the date entered in the Valid To field is earlier than the work date and certification will be canceled.

Set to In Progress
Sets the status of the document to In Progress.

Documents in progress can be edited but aren’t used for document control.

Set to Expired

Sets the status of the document to Expired.

Expired documents cannot be edited (except for their assignment lines). Additionally, they aren’t included in the DMS and cannot be deleted either.

Copy Document

Copies selected data to a new DMS document, with an option to include assignment lines and comments.

Comments

Used to enter comments about the document.

Reserve Bar Code

Reserves a bar code for the document.

Factboxes#

ELO

Can be used to drag and drop an MDR document into, to see the information stored on the document.

Compliance status

Shows the compliance status and history.

MDR documents: compliance#

When you set up the Compliance functionality, you can also choose Table 71076686 (MDR DMS Document) as a compliance tables.

Table 71076684 (MDR DMS Document Assignment) has been added as a subtable.

Job queue: compliance#

If you want document renewals checked and created automatically with the help of the job queue, you must set up an entry in the queue for codeunit 71076791 (MDR Job Queue Handler) with the ‘check renewals’ string.

Lists#

MDR assignments#

MDR assignment lines can be displayed without filters or filtered by item, customer, or vendor.

To see all links available in the system, choose the Search icon, enter MDR DMS Doc. Assignment List, and then choose the related link. The fields on the page correspond to those on the Assignments FastTab of MDR DMS document cards.

Alternatively, open an item card, a customer card, or a vendor card, and then choose Actions > MDR > MDR Assignments on the ribbon to see the links filtered by type of base data.

Document entries#

To see a list of all MDR document entries, choose the Search icon, enter MDR DMS Document Entries, and then choose the related link. See the following table for a more detailed description of some of the fields that you can find on the page. For an explanation of the other fields, see MDR DMS Document List and MDR DMS Document Control.

Log#

You can use the general search function to open the MDR Log page.

Workflow#

Overview#

Throughout this section, a variety of examples will be used to describe the process of document control, covering the review and renewal of MDR documents and their assignment to one of the following records in the system:

Repairs, on the other hand, are represented by one or more service lines on which the CSR Case No. field is filled in with a repair-related case.

Find DMS documents#

As a first step to finding MDR DMS documents related to a document header in the app or a document line on which a certain item was specified, the system searches document control for records that meet the following criteria:

Criterion A

1. For a sale
   The Customer No. field in the record is blank or the number in the field is the same as the sell-to customer number on the sales document.
2. For a purchase
   The Vendor No. field in the record is blank or the number in the field is the same as the buy-from vendor number on the purchase document.
3. For production or assembly
   Customer and vendor numbers aren’t available.

Criterion B

1. For a sale
   The Country/Region Code field in the record is blank or the code is the same as the ship-to country/region code on the sales document.
2. For a purchase
   The Country/Region Code field in the record is blank or the code is the same as the buy-from country/region code on the purchase document.
3. For production or assembly
   A country/region code isn’t available.

Criterion C
The status of the document control record is set to Certified.

Criterion D
The Item No. field in document control is blank (for a header) or the number in the field matches the item number entered on the standard document line.

Criterion E

The Item Version Code field in document control is blank (for a header).

As version codes haven’t been implemented yet on document lines, this criterion is always fulfilled at line level.

Criterion F

The Variant Code field in document control is blank (for a header) or the code in the field matches the variant code entered on the standard document line.

Criterion G

The type of the associated document (such as Sales Order or Purchase Order) has been selected in document control.

As a next step, the system checks each DMS document linked to the records it finds for an assignment line that fulfils the following conditions:

Condition 1

The document type set for DMS assignment matches the type selected in document control.

Condition 2

1. For a sale
   The Customer No. field on the assignment line is blank or the number in the field is the same as the sell-to customer number on the sales document.
2. For a purchase
   The Vendor No. field on the assignment line is blank or the number in the field is the same as the buy-from vendor number on the purchase document.
3. For production or assembly
   Customer and vendor numbers aren’t available.

Condition 3

1. For a sale
   The Country/Region Code field on the assignment line is blank or the code is the same as the ship-to country/region code on the sales document.
2. For a purchase
   The Country/Region Code field on the assignment line is blank or the code is the same as the buy-from country/region code on the purchase document.
3. For production or assembly
   A country/region code isn’t available.

Condition 4
The status of the assignment line is set to Certified.

Condition 5
The Item No. field on the assignment line is blank (for a header) or the number in the field matches the item number on the standard document line.

Condition 6
The Item Version Code field on the assignment line is blank (for a header).

As version codes haven’t been implemented yet on document lines, this condition is always fulfilled at line level.

Condition 7
The Variant Code field on the assignment line is blank (for a header) or the code in the field matches the variant code on the standard document line.

Condition 8

The Relevant Document Date is in the period specified by the Valid From and Valid To fields on the assignment line.

An assignment line found in this way then shows in the DMS Document No. field the MDR records linked to a standard document header or line in the app.

Meet approval requirements#

An approval requirements check is performed on a sales or purchase document line if the Check Approval Reqs. field for the item specified on the line was set to Sales or Sales & Purchasing (for selling the item) or to Purchasing or Sales & Purchasing (for buying it). This check succeeds if:

• The line is linked to a valid document control record that the Document Required field was selected for.
• The MDR document found with the help of document control and DMS assignment is of a document type that the Approval Reqs. field was selected for in the Name part of MDR DMS Structure Setup.

Copy documents#

You can also create an MDR document from an existing document:

1. Open an MDR document.
2. On the ribbon, choose Copy Document.
3. Fill in the fields on the request page as described in the following table.

The status of the MDR document and the assignment lines is set to New when you run this function.

Check for required documents#

If an approval requirements check is run (see Meet Approval Requirements) and the check fails, the system takes measures to remedy the situation.

What these measures look like depends on the option that you selected in the Error Level (Doc. Required) field in document control.

The check is also performed before a document is posted, the only difference being that if you set the error level to Warning in this context, you will not be notified when a process doesn’t pass the check—so that you will not be inundated with messages when posting more than one document at once.

No MDR document entries will be created during the check.

Error levels#

In all examples found in this subsection, an approval requirements check is run for an item that you want to enter on sales documents. However, before you can enter the item, the Check Approval Reqs. field on the associated item card must be set to Sales (or Sales & Purchasing).

Log Level#

On the Log level, an entry is made in the MDR log, and you see a message describing the error that occurred during the check but can continue with the transaction.

Example
You certify a document control record. This record includes a document requirement for sales orders on which the item referenced at the beginning of the section is filled in and document type DRAWING is selected. Afterward, you set the error level to Log. A certified document assignment doesn’t exist.

When you create and release an order on which the item is entered, the order is then recorded in the MDR log, but you will not be informed about any requirements check.

Warning Level#

On this level, you see a message, and an entry is made on the MDR document. After you’ve confirmed seeing the note, you can continue, however.

If you had selected this option in the example situation described earlier, you would now see a message on trying to release the order, telling you about the missing approval requirements.

By choosing OK in the dialog box, you would nevertheless be able to release it while the system would create a log entry for it.

Exit Level#

With the level set to Error, the system shows an error message before canceling the transaction altogether.

Choosing this option in the previous example would show a message describing the error if an attempt were made to release the order, and the order would remain open after confirming the note. A log entry wouldn’t be created.

Print MDR documents#

You can use the Print Document field on the MDR DMS Document Control to specify how you want the system to print MDR documents. Two different approaches can be used. MDR printouts can be added as supporting documents (for example, when you want to sell an item) or by running an action (such as on production orders).

Example
You certify a document control record that includes print settings used for sales and production orders of document type DRAWING.

Afterward, you certify an MDR document that is stored in the DMS (see ELO FactBox) and that is assigned to the item mentioned earlier.

As a result, the MDR document will consist of a text that reads DRAWING.

As Supporting Documentation#

If you want MDR documents printed in the form of supporting documentation, the system searches all DMS document entries referencing the selected document in the app for entries where the Print Document field has been selected.

As an example, you create and release a sales order on which a line is linked to an MDR document with the help of a document entry (which you can see by using the Show MDR Doc. Entries action on the ribbon).

Among other things, this entry shows the standard document header in the Record ID or the relevant line in the Source Ref. No. field, as well as the number of the MDR record and the item number (if available). The Source Event field, on the other hand, specifies the event that led to the creation of the entry, and the Print Document field if the DMS record should be printed as supporting documentation.

When you run the Print Confirmation function on the order, the linked MDR document is then printed together with the confirmation note.

Through use of a function#

As an example, you assign four MDR documents to a production order (one to the header and three to the lines) for when the Refresh Production Order action is run; you can view them by using the Show/Print MDR Docs. function on the ribbon.

Unlike on sales orders, printouts of supporting documentation aren’t available here. Instead, you choose Show/Print MDR Docs. to open or save an MDR record (or exit the dialog box) or Open to view the documents in your default PDF reader and print them there as well.

Prevent more printouts#

Only one MDR document entry can be assigned to each header or line in the system, although more than one can be assigned to the same standard document (that is, to the header and multiple lines). This is to ensure that every MDR document is printed only once. The MDR document entries remain unchanged during this process.

Example
You store the following certified document control records in the system:

Additionally, you make the following MDR assignments for the document types:

For CUST01, you also create and release a sales order that includes two lines where ITM01 and ITM02 have been entered.

When you simulate the creation of MDR document entries for order headers (which no item numbers are entered for), customer CUST01, and country code DE, you then see that two valid document assignments exist for MDR document MDR-28.

Simulating the creation of entries for all order lines with item 01, CUST 01, and DE will get you five valid assignments (one for MDR-28 and two each for MDR-18 and MDR-38).

Performing the simulation for lines with ITM02, CUST01, and DE will also result in five assignments (one for MDR-28, two for MDR-18, and two for MDR-38).

When you release the order, an MDR document entry will be created from each valid DMS assignment simulated for a standard document header (Source Ref. No.= 0) or line (Source Ref. No.= Line No.).

However, the system will prevent entries from being assigned more than once to the same MDR header or line. For example, it will create a single entry from the two valid header assignments for MDR-28 (but all entries for the lines).

When you print the confirmation document as described in an earlier example, each MDR document header and line assigned to an MDR document entry will be printed once, although the confirmation will end up on the first page. This means that MDR-28 (type SALES-QUO) will be printed on page 2, MDR-18 (DRAWING) on page 3 of 4, and MDR-38 (COMPATIBILITY) on the last page.

Inheritance#

Inheritance of DMS information mainly occurs when you post or archive records in the system. Whether document information will be inherited can be specified in the Values Inherited checkbox in document control.

When you post sales or purchase documents or assembly orders for which the field has been selected, their links to MDR documents are copied to the records that you create from them (such as posted shipments, receipts, or invoices).

On production orders, information is inherited when you post journal lines on which the order type Production Order, a production order number, and a production order line number have been specified.

When you archive sales or purchase documents (quotes, orders, and blanket orders), MDR documents will also be copied to the relevant document archives.

Post an assembly order#

As an example, you create and release an assembly order. Two MDR documents are found for it, with one each assigned to the order header and a line. You then pick and post the order so that the MDR documents are linked to the posted record as well.

Afterward, you can choose Show MDR Doc. Entries or Show/Print MDR Docs. on the ribbon to either view the MDR entries set up for the posted document or to view and print the assigned MDR documents.

When you run the Show MDR Doc. Entries action, the entries linked to the document header and lines set up in the app will be displayed in list form, with the Source Ref. No. field showing the line number from the internal document. If the value in the field is 0, the MDR entry has been assigned to the header.

If a document entry is created for a tracked item (that is, an item with a serial or a lot number), the document count on the MDR DMS Entry Hierarchies page is set up and updated in reference to not only the standard document line but also a serial number (source type 6504) or a lot number (source type 6505).

As a result, you can see in the MDR Documents FactBox on the relevant serial or lot number information card how many DMS records have been assigned to it via MDR document entries.

Archive a quote#

As another example, you create and release a sales quote that includes two lines with items on them and have seven document entries created for the header and lines of the document.

Afterward, you use the Archive Document action on the ribbon to archive the quote as version 3 and run the Show MDR Doc. Entries action to have the MDR document entries copied to the archived quote—except for the Source Type and Source Event values, which are updated instead.

Running the Show/Print MDR Docs. function then shows you the MDR documents assigned to the document entries (SALES-QUO MDR-28, COMPATIBILITY MDR-38, and DRAWING MDR-18).

Renewals#

With this feature, you can log rejections of MDR documents that are about to expire, as well as requests for and receipts of new documents.

When you open the MDR DMS Document Renewals page, it is filtered for documents in the New/Requested status. You can change the filter via drill down so that you can see what renewals you have or haven’t received.

The MDR DMS Assignments FastTab, on the other hand, shows the assignment lines available for the currently selected MDR document.

See the following tables for an explanation of individual tab fields.

Filters#

MDR DMS Assignments#

Create a renewal#

You can create document renewals in two ways, namely by running the Check MDR DMS Renewal function or adding document renewal to the job queue.

If you use the ribbon function, you need to choose OK in the dialog box that appears before renewals can be checked. The system then searches for all MDR documents that meet the following conditions:

1. The Renewed On field is filled in.
2. The date in the Renewed On field is earlier than or equal to the work date.
3. The Renewed checkbox isn’t selected.

Afterward, a renewal is created for each document found, and the Renewed field on the document is selected automatically.

Change a status#

On the lines, you can change the renewal status from New to Requested, Received, or Not Rcvd. Depending on the status selected, the system checks which fields must be filled in on a line, as described in the following table.

You see an error message if you try to change the status field although one or more mandatory fields haven’t been filled in yet. The message is updated when you enter the missing values.

When all required fields are filled in and the status of the line is set to Received, you must set the Status Filter field to Received/Not Rcvd. if you still want to see the line.

Changing the status clears the Renewed checkbox. To prevent another renewal from being created, the Renewed On checkbox is emptied as well.

When you change to Not Rcvd., you need to decide whether to delete the current MDR document from monitoring. Only if you choose Yes will the renewal date be deleted from the document so that no other renewal is created.

You can no longer change a renewal record that is set to Received or Not Rcvd.

Create MDR Documents#

For each renewal that you receive, you can create a new MDR document from the old one by running the Create Documents action on the ribbon.

When you run the function, the status fields on the new document are set to New and the New Valid From and New Valid To dates specified for the renewal are copied to it as well. The other field values are transferred from the old document.

New MDR documents can be created for all renewal lines on which the For New Doc. field is selected. To be able to select a line, the following conditions must be fulfilled on it:

1. The New Document No. field must be blank.
2. The Received On field must be filled in.
3. The Checked By field must be filled in.
4. The New Valid From field must be filled in.
5. The New Valid To field must be filled in.

You cannot select a line that doesn’t meet these conditions.

Afterward, you can run the Create Documents action for the selected lines and specify whether you want to copy the comments stored for the old documents.

You see a message when the process is complete. The number of new documents is then entered on the renewal record.

Document compliance#

If MDR document control is integrated into your company’s compliance procedures, the compliance process is started when an attempt is made to change the status of an MDR document to Certified.

You must then enter a compliance text. Afterward, you’re notified that the document cannot be certified until completion of the approval process, which is described here.

Simulate document entry creation#

On the Simulated MDR DMS Entries page, you can simulate the creation of document entries to check your current document control configuration.

After you run the simulation, you will see the entries that could be created according to current setup on the Simulated DMS Document Entries FastTab.

Setup#

To specify filters and documents for the simulation, you must first select a simulated event.

What documents you can select depends on the Customer and Vendor No. fields. If both are blank, you can select only documents from the Miscellaneous category here (production, subcontract, assembly, or repair orders; see Overview), as you need customer numbers for sales and vendor numbers for purchase documents.

Filters#

On this FastTab, you can specify the field values that should be used to simulate the creation of MDR document entries on release of a document or document line in the app or the addition of a new standard document line.

If you don’t fill in the Item No. field on the tab, the system will simulate entry creation for document headers.

Apply Simulated Values to Document Selection#

Simulated MDR DMS Entries#

For an explanation of the other fields on this FastTab, see Document Entries.

Workflow#

As an example, you select Release as the event to simulate and a production order document thereafter. You don’t fill in an item number so that the simulation applies to document headers in the app.

After you run the simulation, the entries that could be created for MDR records MDR-28 and MDR-33 are shown on the Simulated MDR DMS Entries FastTab. The number of simulated entries is shown as a heading.

You then use the lookup on the Entry No. (Doc. Control) field. You see that document type SALES-QUO has been assigned to the production order header on the document control record found for the simulated field values.

Afterward you use the lookup on the DMS Doc. Link Line No. field. This time, you see document MDR-28 linked to type SALES-QUO on the related MDR assignment record.

With the next lookup on the DMS Doc. Link Line No. field, you see document MDR-33 is also assigned to document type SALES-QUO.

Now you rerun the simulation with ITM02 entered in the Item No. filter field. You see that a document entry was created for MDR document MDR-18.

In summary, the simulations show that when a line containing ITM02 and a due date of 08/31/2024 (Relevant Document Dates) is released as part of a production order, MDR documents MDR-28 and MDR-33 would be created for the header and another MDR document, MDR-18, for a line.

If the MDR documents determined in this way do not match your expectations, you need to adjust the setup.