EUDAMED "Clinical Sizes" Import

What it's about

Some form fields in meddevo are list fields: they do not contain a single value, but multiple rows, each consisting of several sub-fields (columns). A typical example is the form field Clinical Sizes - EUDAMED in the product collection, where several clinical sizes are recorded per product - each with size type, unit of measurement, specification type, and the corresponding values.

Previously, these rows had to be entered individually via the user interface. With the Excel import feature, you can now upload them in bulk.

Prerequisite: The feature must be enabled for your workspace. If you are unable to select any list fields as targets when mapping the data from the import, please contact your Customer Support representative.

The Basic Principle

Two basic rules need to be followed structure the file correctly:

1. Each Excel row represents a single entry (e.g., a product)—just like in a standard import.
2. Each subfield gets its own column. If an entry contains multiple list rows, enter all values in the same cell and separate them with a semicolon (`;`).

The values are assembled based on their position: The first value in each column forms the first list row, the second value the second list row, and so on. The order in all columns must therefore match each other.

Example: Two Clinical Dimensions for a Product

Product P-100 is to have a diameter of 5 mm and a length of 12 mm:

• P-100 receives two list lines: "Diameter / Millimeter / 5" and "Length / Millimeter / 12".
• P-200 has only one clinical size - no semicolon is needed here. Simple cases therefore look like a normal import file.

You can name the column headers freely; the assignment takes place in the next step in meddevo.

Empty values within a cell

If a value is missing for a list line, the position must be kept free by two consecutive semicolons so that the assignment does not shift:

Result: Diameter 5, Length without value, Thickness 7.

If a position is empty in all columns, no list line is generated for it.

Process in the Import Assistant

1. Upload file as with the usual entry import.

2. Select unique characteristic - e.g., the item number. It must be a text or number field; subfields of a list field are intentionally not available for selection here.

3. Map columns. Subfields of list fields appear in the target selection in the form `Clinical Sizes - EUDAMED → Clinical Size Type`. Select the appropriate subfield for each column. If your column header is exactly the same as the combination of list field and subfield, it will be pre-filled automatically.

4. *ssign selection values. For subfields with selection lists (e.g., Clinical Size TypeMeasure UnitPrecizion) meddevo displays all values found in your column - the semicolon-separated values are automatically listed individually for this purpose. Assign each value to an existing option.

5. Set update mode (see below). The setting applies to the entire list field.

6. Start import and then check the import report.

Update Mode: Replace or Append

For each list field, define what happens to existing rows:

Because identical rows are recognized and skipped during appending, you can import the same file multiple times without creating duplicates.

"Identical" means: all assigned subfields match. If you assign fewer columns in the second import than in the first, the row is considered divergent and will be created additionally.

Safety net: If all columns of the list field in a row are empty, the list field for this entry remains unchanged - even in Replace. An accidentally empty import therefore does not delete any data.

What the import cannot do

• Delete rows. List rows cannot be removed via import; use the interface for editing.
• Values with semicolon. The semicolon is the delimiter and cannot be part of a value. This also applies to selection options whose name contains a semicolon.
• Multi-selection and reference subfields as well as nested lists are not offered.
• Dates in date cells: If a column contains actual Excel date values, only one date per entry is possible. For multiple dates, format the column as Text

Otherwise, the usual limits of entry import apply (file size, maximum number of rows).

Notes specifically on Clinical Sizes - what EUDAMED expects

If you want to specify a clinical dimension (e.g., length, diameter) for a product, you must fill out several fields together - they are interdependent.

Clinical Size Type

Select here what you want to measure (e.g., “Length,” “Width,” “Diameter”).

This is a required field as soon as you enter any clinical dimensions for this product.

If you select the “Other” option, you must also explain exactly what is meant in a description field - otherwise, EUDAMED will reject the data set.

Precision

This is the setting that determines how the value is recorded. Select exactly one of the three options:

Range → then you must fill in “From” and ‘To’

Value → then you must fill in “Value”

Text → then you must fill in “Text”

Depending on what you select here, the other fields will either be required or remain empty/irrelevant. Never fill in fields that do not match the selected Precision—this will cause errors. Currently, meddevo cannot dynamically show or hide fields based on which ones are relevant at any given time.

• Please fill in completely: A size for which the values corresponding to the specification type are missing - for example, `range` with only one of the two end values, or a missing unit of measurement - will be skipped when transferred to EUDAMED, without a message appearing. Since clinical sizes cannot be changed in EUDAMED after registration, please check the imported rows before submission.
• For the specification type `text`, EUDAMED always uses the size type „OTHER"; a size type specified in the column Clinical Size Type will not be adopted for these rows.
• Values that you do not assign to any option in the mapping will remain empty - the affected list row will still be created, provided that at least one other subfield is filled.

Rule of thumb: First select “Clinical Size Type” and “Precision”—this will automatically determine which of the remaining fields you need to fill out. Simply leave any fields that are not required for the selected precision blank; otherwise, errors may occur when submitting the data to EUDAMED.

Checklist before import

• [ ] One row per entry, item number (or other unique characteristic) filled
• [ ] A separate column for each subfield
• [ ] Multiple list rows separated by `;`, in all columns in the same order
• [ ] Missing values kept free by `;;` at the correct position
• [ ] No semicolons within individual values
• [ ] Update mode consciously selected (Replace overwrites existing rows)
• [ ] For Clinical Sizes: Specification type and corresponding values completely filled