MDR EUDAMED, how to prepare your spreadsheet templates.
The European Commission (EC) delayed the release of MDR EUDAMED until May 26th 2022. This means that you now have to collate, maintain and keep up to date all of your UDI Device data. You have to find some way of preparing and storing this data until EUDAMED goes live. These data elements will not change, the data requirements and mandatory fields will not change. As a result of the delay you must find a way of collating and storing the data in readiness for MDR EUDAMED.
Your UDI Device data is precious and costs a lot to prepare, it must be kept in a safe place. We believe it is a good idea to store it locally where your own IT security protects your data. There are risks associated with storing this data externally, data hacks happen everywhere. Can you afford for your data to be released publicly? It may be safer to manage your own data internally. There are some very simple and cost-effective ways of preparing and managing your data.
The most common questions we get asked at our training courses is how do we prepare a spreadsheet to record our data? Do you have any examples? Can you help us?
It is possible for your in-house team to put together a correctly formatted spreadsheet. This will keep your data in-house where you retain control of your data.
There is some complexity involved with the proposed spreadsheet. First, there are a lot of fields within MDR Eudamed, a lot of mandatory fields, and some fields that can accept multiple entries, particularly language specific fields.
Tips for spreadsheet preparation
- Avoid duplication of data.
- Some elements allow you to add multiple entries e.g. Critical warnings, storage and handling etc. Put this data in a tab specific for this data.
- Any element that allows for multiple languages is data that should be in its own tab.
- For example, if you have one UDI DI on a single row, and needed to enter an ‘additional description’ in 10 languages, then you would need to duplicate the UDI DI row 10 times, thus making the overall management and maintainability virtually impossible.
- The main reason for separating the data elements into tabs is that it won’t be necessary to repeat all the UDI DI data for each multi-language entry.
- Use drop down lists in your spreadsheet for each enum or value list to reduce errors during data entry.
- Enum examples include: issuing entities, storage and handling, critical warnings, languages, countries and many more.
- Highlight the mandatory fields to make data entry easier for the end user.
- Where to find the information? Locating the information will require research the following are the three main sources of information for you:
- Firstly, the data dictionary V5 was recently published (Dec 2019) and has an abundance of information, from occurrences (multiple entries) and data types to what enumerations are used.
- To find the enumerations is a bit of work because the EC have yet to publish the full lists. For now, you need the XSD’s. Inside the XSD’s the enumerations are detailed. Locate the required entity name in the data dictionary and use this to search the XSD which will bring you to the enum or value list. These are the options you must include in your XML when you upload to EUDAMED.
- The UML diagrams are a great source of information including mandatory and multiple entry fields.
The preparation of the spreadsheet takes a lot of time. For the Eudamed.eu available spreadsheets, we estimated that we spent well in excess of 175+ hours creating ours, and that is before we started on the business rules.
To save you a lot of time and research, our spreadsheets are available for you to purchase. They are split into two packages, MDR and IVDR. Each spreadsheet has some legislation specific MDR EUDAMED rules built in. The inclusion of the business rules is to help with the overall MDR EUDAMED data preparation and long-term maintainability of the data.
Regardless of creating your own or purchasing our spreadsheets, you must to start keeping collated device records, which will greatly reduce the level of work needed when MDR Eudamed goes live. If you need further assistance, training, or would like to purchase our spreadsheet templates please go to our website for further information, https://eudamed.eu