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MDR Questionnaire

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

‘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 already performed a clinical trial with the product?*
In case your answer to the previous question was YES.
Does the device have a clinical investigation plan?*
Does the device contact with the human body?*
The duration of a single continuous use of the device:*
In case the device is used several times.
How does the device contact with the human body?*
Does the device penetrate into the human body?*
Has the device been classified based on MDR?*
In case your answer to the previous question was YES.
Is this an active device?*
‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device.
Is the device designated as sterile?*
Does the device have a measuring function?*
Does the device contain any of the following materials?*
Is the device a reusable surgical instrument?*
'Reusable surgical instrument' means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.
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 trial information

Do you have a preferred clinical trial site?*
Do you have a preferred biostatistician, data management 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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