IVDR EUDAMED Templates
IVDR applies from 26th May 2022.
Our IVDR and IVDD templates help you collate, manage, and version, all your medical device data as required by European Commission and EUDAMED.
This is a digital product and once downloaded no refunds are possible.
More information and FAQ are below…
IVDR Applies from May 26th 2022
EUDAMED data must be prepared and collated for upload to the EC’s EUDAMED.
The simplest way is in a spreadsheet across multiple tabs to capture all information.
Purchasing these template’s saves you hours of work. 175+ hours to create.
|Template customers have said:
|The package includes three templates packed with functionality:
IVDR and IVDD Templates
Basic UDI (partial)
UDI DI (partial)
Save hours of work – Perfect for data collation
Ease of use with built-in navigation
Frequently answered questions:
Q: Will there be an annual charge for updates?
A: No. €395 is a one-off fee. Any updates we will provide to you at no additional charge.
Q: Will this spreadsheet help us with our EUDAMED uploads?
A: Yes, but not 100% you will still have to convert the data to XML. We have designed the spreadsheet to make this process a lot easier, the tabs in the spreadsheet are more or less what is needed for EUDAMED. We have also included an option for you so that you can upload this spreadsheet to our online application which will take the data marked for EUDAMED and convert it, validate it and push it to the EC for you. This, of course, is an option for you.
Q: Will this facilitate XLSX to XML at this time?
A: For now, this conversion is a separate service. The XML conversion because of the complexity we are keeping external to the spreadsheet. It is available via our online systems.
Q: Can you speak to the degree of “validation” against which field values are held? [how many fields in total are there, how many total rules/ cell value restrictions would an ideal template have? how many of those rules/cell value restrictions are already implemented within this template?]
A: We have not restricted any fields. We highlight the mandatory and the dependent applicable fields (if you select true a neighbouring cell may become mandatory).
Q: Do you anticipate updates? Will licensees of this template receive updates or be offered discounts on upgrades?
A: All licensees will always receive updates free of charge. Updates yes, these will happen, but only to the enumeration or value lists form the EC. Some of which have yet to be published e.g. critical warnings. To avoid issues with this we have a separate enum spreadsheet which we will update, and send to clients as and when the EC provides new ones. This spreadsheet feeds the MDR, MDD etc spreadsheet with the lists, these are the only real restrictions within the system.
Q: Do you anticipate the publication of the business rules will impact any aspects of this template?
A: We have not covered every single rule within the template, the main ones regarding risk classes, mandatory fields and the if applicable. It would be impossible to cover every rule in a spreadsheet without making it unworkable but for now, we have done a pretty good job with it. Lots of macros and rules, but also, we have pipelined them one for each regulation/directive MDR, MDD, SPP, IVDR and IVDD, this in itself takes care of many rules.
I do not expect any major changes to the UDI Device requirements or rules. This module is pretty well decided. Vigilance is the next one to tackle when they start releasing information.
|The IVDR package includes two templates packed with functionality:
IVDR and IVDD Templates