Government adopted additional regulation on medical devices – obsolete*

On 24 March 2020, the Government adopted the Regulation on Special Technical Requirements, Standards, and Application of Medical Devices During the Emergency Caused by the COVID-19 Disease, Caused by the SARS-CoV-2 Virus (the “Regulation” ), following recommendations contained in legal norms. This Regulation prescribes specific technical requirements, standards and instructions for medical devices during the state of emergency.

It also foresees that medical devices, which were not manufactured following prescribed standards can be used in treatment, provided that the manufacturer or distributor delivers the appropriate documentation to the authorities, which includes the following:

a copy of the description of technical characteristics and the instruction manual for the medical device, with translation into Serbian;
a statement that the use of the medical device ensures its effectiveness in the treatment, i.e. that the device meets conditions of effective treatment, as well as an appropriate device that regularly meets the standards;
a statement that the manufacturer or distributor will train health professionals who will provide treatment;
a statement of commitment to provide maintenance services and spare parts for the medical device specifying the validity period of such commitment;

Such a solution means that manufacturers can offer innovative medical devices, which have not been registered yet if those devices have proven effective in the treatment of the coronavirus. Normally, such medical devices would not be used without registration, however, this Regulation allows that medical devices for particularly urgent treatments can be included in therapy.

The need for such healthcare measures was also recognized within the EU, while the area of import of medical equipment used in treatment of the coronavirus is also specifically regulated. You can read more about this in our article linked here.

What is the manner of procurement?

The issue of procurement on part of healthcare providers is also covered by the Regulation. The procurement procedure for medical devices is subject to provisions of the Public Procurement Act, which prescribed the procedure in case of natural disasters, i.e. an epidemic. For more about coronavirus procurement read more here.

For more information, please contact us via covid19@geciclaw.com