Clinical Size Types : Meaning and integration in EUDAMED

The introduction of Unique Device Identification (UDI) has resulted in medical device manufacturers being required to provide health authorities such as the FDA or EUDAMED with a wide range of product information. The so-called “Clinical Size Types” are an integral part of these UDI regulations for medical devices, as they must be included in the information provided on the label.

Clinical Size Types are part of the attributes of the UDI-DI. They refer to a classification of medical devices based on their clinical sizes or dimensions. This information is an important part of the Unique Device Identification (UDI) system as defined in the EUDAMED Regulation. The Clinical Size Type helps identify and track medical devices based on their specific size attributes. This can be critical for patient treatment, documentation and safety.

Multiple clinical sizes can be added for the device. The clinical size is defined by the type, precision, value (either range, single value, or text), and unit of measurement.

Example: “Length”, “Width”, etc.

According to the UDIWG 2018-1 they are defined as follows: “Numerical value for the clinically relevant size specification of the medical device, as indicated on the label. Where applicable, the manufacturer shall associate a clinical size range with a base UDI-DI and a specific clinical size for each relevant UDI-DI.”

Guideline for filling out Clinical Size Types in EUDAMED

When filling out the Clinical Size Types in EUDAMED, the following points should be noted:

• The different Clinical Size Types are presented as a drop-down list. So you only need to select the right elements.
• You can add several Clinical Size Types.

• After selecting the type, you must specify the precision (either Range, Single Value or Text), the value and the unit of measurement.

• If the selected type of Clinical Size is the option “Other”, the product manufacturers must enter the description themselves. The same applies to the unit. The description and the size type should be provided in English as well as in the languages of the countries where the product is made available (MDCG 2018-7).

We have prepared a video that shows you exactly how to add Clinical Size Types in our EUDAMED Add-On: