It is difficult to imagine the modern health protection system  without medical devices and medicines. It is impossible to perform different tasks of medical diagnostics and treatment when not using these products.

Turnover, in particular, of the medical devices in Ukraine is connected with certain difficulties, like around the world, because of their wide variety, those difficulties residing both in the classification, and in attitudes to the regulation. In order to solve these tasks, a unified informational approach is necessary when working out, manufacturing, assessing, purchasing and operating  medical devices.

What do you do if the medical device and the medicine make up a whole and can not be used separately? Should these product be considered as a medicine or as a medical device?  What kind of regulatory attitude exists in the world and in Ukraine? We shall try, in this article, to outline European experience and find ways to solve issues to assess these devices.

The medical devices are of different shapes and sizes, from syringes  all the way to pacemakers. All medical devices have to conform to Technical regulations concerning  these devices, approved by the Decree of the Cabinet of Ministers of Ukraine № 753 of 02.10.2013 in order to have the right to mark devices with the conformity mark and place them in the Ukrainian market, but if the medical device includes the medicine, some additional specific requirements should be met.

It may become a difficult task to define the right approach to the regulation concerning combined the product.

According to the Technical regulations the medical device shall be any tool, apparatus, instrument, contrivance, software, material or any other device to be used both separately, and in combination with each other (including software, provided by the manufacturer to use specifically for the diagnostic and/or therapeutic purposes and necessary for the proper work of the medical device). This is designed by the  manufacturer to ensure diagnostics, preventive care, monitoring, treatment or  relief of patient’s disease in case of illness, diagnosis, monitoring, treatment, alleviation of the patient’s disease in case of injury or disability or the compensation of them, study, replacement, modification or support of the anatomy or physiological process, fertilization process control and basic envisaged action of which in the human body or on the human body shall not be achieved by virtue of pharmacological, immunological or metabolic means, but whose functioning shall be assisted by such means.

According to the Law of Ukraine “On medicines” one should consider as the medicine any substance or a combination of substances (of one or several АPІ (active pharmaceutical ingredient) and ancillary substances), possessing properties and intended for treatment or preventive care of diseases of humans, or any substance or a combination of substances (of one or several АPІ and ancillary substances), which may be designed to prevent pregnancy, for the recovery, correction or modification of physiological functions in  the human body by way of  pharmacological, immunological or metabolic action or for the medical diagnosis.

Primary importance for determining the mechanism of  the legislative regulation has the main mode of action, of the combined product including both medical device and substance, which in cases of its separate use may be considered as the medicine.

Further as the text goes let us instead  of using such complicated word combination as «substance, which in case of its separate use may be considered as the medicine» use the phrase «Ancillary Medicinal Substance».

The medical devices achieve their main anticipatory action by virtue of physical or mechanical properties. They may be, however be, ancillary factors for the pharmacological, immunological or metabolic means.

There are two kinds of medical devices which include Ancillary Medicinal Substance.

The combined products belong to the first kind, designed to deliver the preparation, they are supplied along with the medicine, but they are not reusable (e.g., syringe prefilled with insulin). These kind of products are the object of the regulation according to the Law of Ukraine “On medicines”.

The second kind is the medical device, which includes a substance, which, if used separately, is classified as the medicine. If action of the preparation is the ancillary one to the action of the device (e.g., stents, covered with medicine, antibiotic containing bone cement, antiseptic plasters), such product shall be regulated as the medical device.

Key questions to be answered when defining the belonging of the devices. If the action is “the ancillary one» include the following: what is in the base of the mode of action, how does the product achieve its designed purpose, what is of the preparation on the human body.

If the main mode of action of the device is achieved by virtue of physical means, but not at the cost of the effect of the preparation, that product is an object of the Technical regulations.

Nowadays, most questions arise regarding plasters, containing  substances, which if used separately, may be considered as a medicine. In one case it may be the medical device, in another one it may be considered as a medicine.

The combined product, which shall mainly be used  to treat a disease and the plaster shall perform a supporting role, e.g., shall perform the delivery, then such device shall be regulated by the legislation in the sphere of a medicines.

The combined product shall be considered as the medical device, if the main mode of action concerning wound is a physical one (then is absorption of exudates from the wound). The wound protection is achieved by virtue of physical means, by way of use of dressing material, and the wound care by means of the preparation, wich is the accessory factor. Such combined product shall belong to class ІІІ according to the rule 21 of Addendum ІІ of the Technical regulations.

These are the highest indicator of the classification of risks of the medical devices, those including a medicinal component. This is crucially important for the establishing  the correct classification of the medical device.

The manufacturers of such medical devices use, as a rule, procedure «Procedure of implementation of comprehensive quality management system”, set forth in Addendum 3 of the Technical regulations in order to prove the conformity of the devices to the requirements of the legislation.

Also the procedure of the project check also, has to be performed according to this procedure, objective data should be collected so as to demonstrate evidence of conformity to the basic requirements, described in Addendum I of the Technical regulations. The project file should be studied by the designated body and an audit of  the manufacturer’s quality management system has to be performed.

The manufacturer has to prepare a project file, containing accurate description regarding quality, safety and usefulness of the drug substance, as well as to provide information concerning the substance, which is included into the finished device.

The Conformity assessment body has to refer to the competent authority (it is the State Center for Drug Evaluation and Research of MHC of Ukraine) prior to making a decision concerning the compliance of the devices with the regulatory requirements.

The quality, safety and effectiveness of this substance shall be checked according to the requirements of  the Law of Ukraine “On medicines”.

Upon the testing of the effectiveness of the indicated substance as a part of the medical device with regard to designated use of this device,  the Conformity assessment body shall  then send it to the State Center for Drug Evaluation and Research of MHC. A request regarding the preparation of the findings concerning effectiveness, safety and the quality of the medicine, in particular, in respect of clinical risk/rewards allocation in case of inclusion of the indicated substance into the medical device. During the preparing of the findings the State Center for Drug Evaluation and Research of MHC shall take into account the manufacturing process and data regarding effectiveness of the inclusion of the indicated substance into the medical device, as is indicated by the conformity assessment body.

The findings of the State Center for Drug Evaluation and Research of MHC should be submitted within 210 calendar days upon receiving the completed set of documents. The findings shall be included into the documentation concerning the indicated medical device. The conformity assessment body takes into consideration the findings, obtained in the course of such advice at the time of making a decision concerning issuance of the certificate of the verification of the medical device project. The indicated body informs the State Center for Drug Evaluation and Research of MHC of Ukraine of the decided upon  decision concerning issuance of the certificate of the verification of the medical device project.

There are risks, pertaining to the administration of the drug substance in combination with the medical device, making the conformity assessment process more complex. The matter of the patients safety is critically important issue. There should be a high-degree of certainty that the use of the device shall be safe for the patient – with the minimum risk or without it. This responsibility is borne by all participants of the  conformity assessment process to ensure that the medical devices, used by the patients-Ukrainian citizens, should not only be effective, but also safe.

Tetiana Pazerska, Chief auditor of Ukrainian conformity assessment body Improve Medical LLC

www.improvemedical.com.ua

«IMPROVE MEDICAL» — is Ukrainian authorized body for assessment of conformity of medical devices

The authorities of the company cover the assessment of the conformity of the products to the following technical regulations:

№ 753 «Medical devices»;

№ 754 «Medical devices for diagnostics in vitro»;

№ 755 «Active implantable medical devices».