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IVDR Questionnare
Company information
Company name
*
Headquarters (Zip)
*
Headquarters (City)
*
Headquarters (Street address)
*
Website URL
Number of employees
*
Contact's Last name
*
Contact's First name
*
Job Title
Contact's email address
*
Contact's phone number
Sites (if there is production or development acitivity outside the headquarters)
Site (City)
Activity
Number of employees
Does the company maintain a certified quality management system?
Yes, according to ISO 9001 standard
Yes, according to ISO 13485 standard
No
Is financial funding needed to implement the project?
Yes
No
The fund is available from:
In case your answer to the previous question was YES.
Product information
Name of the device(s):
*
The product is an in vitro diagnostic medical device or an accessory to an in vitro diagnostic medical device?
*
in vitro diagnostic medical device
accessory to an in vitro diganostic medical device
Name of the accessories of the device(s):
*
Intended purpose of the device(s):
*
‘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?
*
Yes
No
Have you performed analytical performance tests on the product?
*
Yes
No
Results of the study (e.g. sensitivity, precision, reproducibility, etc):
In case your answer to the previous question was YES.
Have you already performed a clinical performance study with the product?
*
Yes
No
Brief description of the study (type of trial, results; e.g. postmarket or clinical performance study, diagnostic specificity, sensitivity):
In case your answer to the previous question was YES.
Do you have clinical performance study plan?
*
Yes
No
Has the device been classified based on IVDR?
*
Yes
No
The device is classified as the following class:
In case your answer to the previous question was YES.
The IVDR device, based on intended purpose:
*
If the device has NOT been classified.
to be used for blood grouping or for tissue typing
for detecting of an infectious agent
to be used as companion diagnostic
to be used in screening, diagnosis, or staging of cancer
for human genetic testing
for self-testing
for screening for congenital disorders
products for general laboratory use
specimen receptacles
other
In case of other intended purpose, please describe:
In case of companion diagnostic, please name of the related medicine:
Is the device labelled as sterile?
*
Yes, it must be shipped sterile
No
Does the device have a measuring function?
*
Yes
No
If yes, what physical quantity does it measure? (quality, quantity, half-quantity)
Is there a control (embedded) software in the device?
*
Yes
No
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.).
Yes
No
Clinical performance study related information
Do you have a preferred clinical trial site?
*
Yes
No
Do you have a preferred biostatistician, data management partner, partner or contact?
*
Yes
No
Do you have a preferred contact for clinical trial regulatory administration?
*
Yes
No
Do you have a preferred CRO (independent monitoring)?
*
Yes
No
Requested services
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
Company name
*
Filler's name
*
Filler's position
*
Certificate
Date
Month
/
Day
/
Year
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.
Certificate
Attachments
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