Is device intended for channeling or storing blood, body fluids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body?

Is device intended for modifying biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or administration into the body?

May a device be connected to a class IIa, class IIb or class III active device?

Is product a blood bag?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 2.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended for storing organs, parts of organs or body cells and tissues?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 2.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class I Rule 2.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 2.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is it device which comes into contact with injured skin or mucous membrane?

Is it device consisting of a substance or a mixture of substances intended to be used IN VITRO in direct contact with human cells, tissues or organs taken from the human body?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 2.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is it device consisting of a substance or a mixture of substances intended to be used IN VITRO with human embroys before their implantation or administration into the body?

The classification has been successfully completed!
Device resides within:

Class III Rule 3.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 3.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class I Rule 1.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to be used as a mechanical barrier, for compression or for absorption of exudates?

The classification has been successfully completed!
Device resides within:

Class I Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to be used principally for skin injuries which have breached the dermis or mucous membrane and can only heal by secondary intent?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device principally intended to manage the micro-environment of injured skin or mucous membrane?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is the treatment for which device is used consists of filtration, centrifugation or exchanges of gas or heat?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 3.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is it an invasive device with respect to body orifices or stoma, other than surgically invasive device?

Is device a surgically invasive device or implantable device?

Is device intended for transient use (< 60 min)?

Is device intended for shortterm use (60 min < use time < 30 day?)

The classification has been successfully completed!
Device resides within:

Class I Rule 5

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended for longterm use (>30 day)?

Is device intended to be used in:
- the oral cavity as far as the pharynx, or
- an ear canal up to the eardrum, or
- the nasal cavity;

The classification has been successfully completed!
Device resides within:

Class IIa Rule 5

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class I Rule 5

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended for connection to a class IIa, class IIb or class III active device?

Is device intended to be used in:
- the oral cavity as far as the pharynx, or
- an ear canal up to the eardrum, or
- the nasal cavity;

and not liable to be absorbed by the mucous membrane?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 5

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 5

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class I Rule 5

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 5

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to administer medicinal products by inhalation or introduced into the human body via a body orifice or applied to the skin?

Is it a surgically invasive device intended for transient use (< 60 min)?

Is it a surgically invasive device intended for short-term use (60 min < use time < 30 days)?

is a device intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body?

Is it an implantable or surgically invasive device intended for long-term use (> 30 days)?

Is a device intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body?

Please revisit the Main menu

Main Menu

Is device intended to be used in direct contact with the heart, the central circulatory system or the central nervous system?

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to undergo chemical change in the body (not in teeth)?

Is device intended to be placed in the teeth?

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Does device have a biological effect or it is wholly or mainly absorbed?

Is device intended to administer medicinal products (not in teeth)?

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device an active implantable devices or its accessory?

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device a breast implant or surgical mesh?

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device an total or partial joint replacements (except ancillary components such as screws, wedges, plates and instruments)?

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device an spinal disc replacement implants or are implantable devices that come into contact with the spinal column (except components such as screws, wedges, plates and instruments)?

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class III Rule 8.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system?

The classification has been successfully completed!
Device resides within:

Class III Rule 7.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Does device have a biological effect or is it wholly or mainly absorbed?

The classification has been successfully completed!
Device resides within:

Class III Rule 7.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to supply energy in the form of ionising radiation?

The classification has been successfully completed!
Device resides within:

Class III Rule 7.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to undergo chemical change in the body (not in teeth)?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 7.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

is device intended to administer medicines?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 7.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 7.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 7.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system?

The classification has been successfully completed!
Device resides within:

Class III Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Does device have a biological effect or is it wholly or mainly absorbed?

The classification has been successfully completed!
Device resides within:

Class III Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to supply energy in the form of ionising radiation ?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device a reusable surgical instrument?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to administer medicinal products by means of a delivery system?

The classification has been successfully completed!
Device resides within:

Class I Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application?

Is it an invasive device that comes into contact with injured mucous membrane?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Please re-visit the Main menu

Main Menu

Is it invasive (non-surgical) device with respect to body orifices intended to administer medicinal products by inhalation?

Is device composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body?

Is device's mode of action has an essential impact on the efficacy and safety of the administered medicinal product?

Is device intended to treat life- threatening conditions?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 20.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 20.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 20.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Please re-visit the Main menu

Main Menu

Is device or its products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose?

The classification has been successfully completed!
Device resides within:

Class III Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Does device achieve its intended purpose in the stomach or lower gastrointestinal tract and device or its products of metabolism, are systemically absorbed by the human body?

Is device applied to the skin?

The classification has been successfully completed!
Device resides within:

Class III Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device applied in the nasal OR oral cavity as far as the pharynx, and achieve its intended purpose on those cavities?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 6.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is invasive device principally intended to manage the microenvironment of injured skin or mucous membrane?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is invasive device intended to be used principally for skin injuries, which have breached the dermis or mucous membrane and can only heal by secondary intent?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is a device intended to be used as a mechanical barrier, for compression or for absorption of exudates?

The classification has been successfully completed!
Device resides within:

Class I Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 4.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is it an active monitoring or control device OR device which directly influence other active medical device?

Is device an active device therapeutic device?

Is device intended to control, monitor or directly influence the performance of active therapeutic class IIb device?

Is device intended to control, monitor or directly influence the performance of diagnostic OR therapeutic radiology incl. interventional radiology device?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 9.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to control, monitor or directly influence the performance of active implantable devices?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to control, monitor or directly influence the performance of devices intended to emit ionizing radiation for therapeutic purposes?

The classification has been successfully completed!
Device resides within:

Class III Rule 9.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to supply energy which will be absorbed by the human body?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 9.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to illuminate the patient's body in the visible spectrum?

is device intended to image in vivo distribution of radiopharmaceuticals?

The classification has been successfully completed!
Device resides within:

Class I Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to allow direct diagnosis or monitoring of vital physiological processes?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is the nature of diagnosis or monitoring parameters variations such that it could results in immediate danger to the patient?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended for diagnosis in clinical situations where the patient is in immediate danger?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 10

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended to emit ionizing radiation for therapeutic purposes?

Is device intended to administer and/or remove medicinal products, body liquids or other substances to or from the body?

Is device intended to emit ionizing radiation and intended for therapeutic radiology incl. interventional cardiology devices?

Is it an therapeutic device intended to administer or exchange energy?

May device administer energy to/ or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 9.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 10.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 9.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 9.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Does device operate in a potentially hazardous manner, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application

The classification has been successfully completed!
Device resides within:

Class I Rule 13.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 12.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 12.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is software intended to provide information which is used to take decisions with diagnostic or therapeutic purposes?

The classification has been successfully completed!
Device resides within:

Class I Rule 11.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

May decision, which is based on information provided by the software, have an impact that cause death or an irreversible deterioration of a person's state of health?

May decision, which is based on information provided by the software, have an impact that cause serious deterioration of a person's state of health or a surgical intervention?

The classification has been successfully completed!
Device resides within:

Class III Rule 11.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is software intended to monitor physiological processes?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 11.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 11.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is software intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 11.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 11.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC?

Note: Including a medicinal product derived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive and that has an action ancillary to that of the devices?

Please re-visit the main menu for new selection and product classification

The classification has been successfully completed!
Device resides within:

Class III Rule 14.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device used for contraception or prevention of the transmission of sexually transmitted diseases?

Please re-visit the main menu for new selection and product classification

Is it implantable or long term invasive device?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 15.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class III Rule 15.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended specifically to be used for disinfecting, cleaning, rinsing or, where appropriate, hydrating contact lenses?

Note: Cleaning by means of physical action only

Please re-visit the main menu for new selection and product classification

The classification has been successfully completed!
Device resides within:

Class IIb Rule 16.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device intended specifically to be used for disinfecting or sterilising medical devices?

Please re-visit the main menu for new selection and product classification

Is disinfecting solution or washer disinfector intended specifically to be used for disinfecting invasive devices, as the end point of processing?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 16.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 16.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device specifically intended for recording of diagnostic images generated by X-ray radiation?

Please re-visit the main menu for new selection and product classification

The classification has been successfully completed!
Device resides within:

Class IIa Rule 17.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable?

Please re-visit the main menu for new selection and product classification

Is device manufactured utilising tissues or cells of animal origin, or their derivatives intended to come into contact with intact skin only?

The classification has been successfully completed!
Device resides within:

Class I Rule 1.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class III Rule 18.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

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Is device incorporating or consisting of nanomaterial which present a high or medium nanomaterial, which present a high or medium potential for internal exposure?

Is device incorporating or consisting of nanomaterial, which present a low potential for internal exposure?

The classification has been successfully completed!
Device resides within:

Class III Rule 19.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

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Is device incorporating or consisting of nanomaterial, which present a negligible potential for internal exposure?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 19.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

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Please re-visit the main menu for new selection and product classification

The classification has been successfully completed!
Device resides within:

Class IIa Rule 19.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

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Is it invasive (non-surgical) device with respect to body orifices intended to administer medicinal products by inhalation?

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Is device's mode of action has an essential impact on the efficacy and safety of the administered medicinal product?

Is device intended to treat life-threatening conditions?

The classification has been successfully completed!
Device resides within:

Class IIb Rule 20.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

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The classification has been successfully completed!
Device resides within:

Class IIa Rule 20.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 20.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is device composed of substances OR of combinations of substances that are intended to be introduced into the human body via a body orifice OR applied to the skin and that are absorbed by or locally dispersed in the human body?

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Is device or its product of metabolism, systemically absorbed by the human body in order to achieve the intended purpose?

Does device achieve its intended purpose in the stomach or lower gastrointestinal tract, and device or its product of metabolism is systemically absorbed by the human body?

The classification has been successfully completed!
Device resides within:

Class III Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

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Is device applied to the skin?

The classification has been successfully completed!
Device resides within:

Class III Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

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Is device applied in the nasal OR oral cavity as far as the pharynx, and achieve its intended purpose on those cavities?

The classification has been successfully completed!
Device resides within:

Class IIa Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIb Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

The classification has been successfully completed!
Device resides within:

Class IIa Rule 21.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba

Is it active therapeutic device with an integrated or incorporated diagnostic function which significantly determines the patient management by the device, such as closed loop systems or automated external defibrillators?

Please re-visit the main menu for new selection and product classification

The classification has been successfully completed!
Device resides within:

Class III Rule 22.

According to Annex VIII of Regulation (EU) 2017/745 on medical devices (MDR)

For additional information please contact our consultant at:

Contact form or info@qualitycert.ba