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MDR Questionnaire
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):
*
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 already performed a clinical trial with the product?
*
Yes
No
Brief description of the trial (type of trial, results):
In case your answer to the previous question was YES.
Does the device have a clinical investigation plan?
*
Yes
No
Does the device contact with the human body?
*
Yes, indirect (the device does not touch the patient, but its material may pose a biological risk [e.g. via potential release] for the patient (e.g. infusion bag, syringe)
Yes, with direct (direct contact between the device and the patient (e.g. bandage, implant)
No
The duration of a single continuous use of the device:
*
Less than 60 minutes
Between 60 minutes and 24 hours
Between 24 hours and 30 days
Longer than 30 days
The device will be used several times
What is the frequency of use?
In case the device is used several times.
How does the device contact with the human body?
*
Contact with the skin surface (e.g. rubber gloves, ECG electrode)
Contact with a mucosal surface (e.g. contact lens, bladder catheter)
Contact with a damaged surface (e.g. wound dressing device, hydrogel dressing)
Indirect contact with blood vessels (e.g. infusion set)
Contact with tissue/bone/dentin (e.g. laparoscope, dental filling material)
Circulating blood (e.g. intravascular catheter, dialysis tubes)
Implantation into tissue/bone (e.g. hernia mesh, bone screw)
Implantation in blood vessels (vessels, heart) (e.g. pacemaker electrode, artificial heart valve)
The material(s) of the device that come into contact with the patient.
Does the device penetrate into the human body?
*
Yes, surgically through the surface of the body, including the mucous membrane of body orifices.
Yes, through a body orifice (any natural orifice in the body, including the outer surface of the eyeball, or any permanent, artificial orifice, such as a stoma.)
No
Has the device been classified based on MDR?
*
Yes
No
It is classified as the following class:
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.
Yes
No
Is the device designated as sterile?
*
yes, it must be shipped sterile
yes, it must be sterilized by the user, not to be shipped sterile
no
Does the device have a measuring function?
*
Yes
No
If yes, what physical quantity does it measure?
Does the device contain any of the following materials?
*
Yes, medicine
Yes, human blood derivative
Yes, tissues or cells of human or animal origin or the derivatives of them which are rendered non-viable
No
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.
Yes
No
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 trial information
Do you have a preferred clinical trial site?
*
Yes
No
Do you have a preferred biostatistician, data management 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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