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IVDR Questionnare 

Company information

Sites (if there is production or development acitivity outside the headquarters)
Does the company maintain a certified quality management system?
Is financial funding needed to implement the project?
In case your answer to the previous question was YES.

Product information

The product is an in vitro diagnostic medical device or an accessory to an in vitro diagnostic medical device?*
‘Intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
Is the CE marked device already on the market?*
Have you performed analytical performance tests on the product?*
In case your answer to the previous question was YES.
Have you already performed a clinical performance study with the product?*
In case your answer to the previous question was YES.
Do you have clinical performance study plan?*
Has the device been classified based on IVDR?*
In case your answer to the previous question was YES.
The IVDR device, based on intended purpose:*
If the device has NOT been classified.
Is the device labelled as sterile?*
Does the device have a measuring function?*
Is there a control (embedded) software in the device?*
Does the device communicate via an IT network or does it have any data output (e.g. USB port)?*
"IT network" means a system or systems that include communication nodes and transmission links to provide a physically connected or wireless connection between two or more specified communication nodes (eg Bluetooth, wired or wireless Internet connection, etc.).

Clinical performance study related information

Do you have a preferred clinical trial site?*
Do you have a preferred biostatistician, data management partner, partner or contact?*
Do you have a preferred contact for clinical trial regulatory administration?*
Do you have a preferred CRO (independent monitoring)?*

Requested services

Please indicate the services you wish to use based on QTICS Medical Service Catalogue (the list can be extended according to the number of services). You can find the online version of the Service Catalogue HERE.

Filler

Certificate

Date
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As the representative of the contracting, I certify that the information described in the questionnaire adequately describes the characteristics of the medical device and the details of the company.
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