Now it is time for you to have a closer look at the risks concerning your file. There are two ways to do that:
The next steps could be:
On the Technical files page where you see a list of all your Technical Files, a status block indicates how many documents are still missing from the Technical file. The color of the block indicates the compliance risk, with red indicating a high risk, orange a medium risk and green a low risk.
By placing the mouse pointer on the block, an overview appears of all missing documents, grouped by risk level.
The risk level is classified as high by default for all documents.
You can adjust this to medium or low for specific documents at your own discretion, possibly only for specific projects, file groups, product risk levels and product categories.
13 documents are missing, at least 1 of which is high risk
5 missing documents, medium or low risk, at least 1 with a medium risk
3 documents are missing, all with a low risk
All documents have been collected
No regions or product category have been chosen yet
20 documents are missing, but the file deadline is more than 6 weeks in the future (the 6 weeks mentioned will be a customizable account setting)
No regions or product category have been chosen yet, but the file deadline is more than 6 weeks in the future
The file has not yet been activated
When you decide that you have enough compliance evidence in order to release the product into the market, you should set the file to FINAL status. Go to the Product tab, Click on the active state in the toolbar (example image below) then set the status of the file to Close for final review.
Finally, a situation may arise in which changes are made in the legislation applicable to the file after the file has been created and activated.
This usually occurs when the market release date of the file is further in the future. The further the date, the greater the chance that new legislation will be published in the interim that was not known at the time the file was created.
For such files, a red banner has been shown in the file for some time to make aware of this, with a link with which you can update the list of requirements free of charge.
It is now also possible to create a tab on the technical files page that shows all files that need such an update.
The column reorder expiry shows the date from which the file is no longer suitable as proof of compliance for a reorder of the product, because from this date one of the documents is no longer valid or new legislation comes into effect that is not included in the current list of requirements of the file.
Clicking on the date shows an overview of expired documents and changes in the requirements list per the reorder expiry date or per today if that date is in the past.