The article was drafted by Mirjana Mladenović Paripović and Suzana Pavlovic for Lexology on November 11,2026
Legal Framework for Medical Device Manufacturers and Distributors
Introduction
Cooperation between medical device companies and healthcare professionals is an established practice in the healthcare industry. Manufacturers and distributors frequently engage physicians and other healthcare professionals to provide consultancy services, professional training, technical assistance, patient education and market research.
These activities may serve legitimate commercial, educational and professional purposes. However, they also raise important legal questions, particularly where healthcare professionals receive remuneration from companies whose products they may prescribe, recommend or use in their daily practice.
Under Serbian law, such arrangements must be carefully assessed in light of the restrictions governing the promotion of medical devices and the prohibition of financial and other incentives intended to influence healthcare professionals’ independent judgment.
The central legal question is therefore whether remuneration constitutes genuine compensation for services actually performed or an improper incentive to influence the prescription, recommendation, procurement or use of medical devices.
What is the legal Framework in Serbia?
The principal legislation governing the promotion of medical devices in Serbia is the Law on Medical Devices (Official Gazette of the Republic of Serbia, No. 105/2017, Zakon o medicinskim sredstvima” Law on Medical Devices”
Articles 112 and 113 of the aforementioned Law address the promotion of medical devices to healthcare devices and impose restrictions on certain promotional practises, as cited below. In particular, art. 113 prohibits specified forms of offering or promising financial rewards, gifts or other benefits intended to influence decisions about the prescription, dispensing, procurement, recommendation, use or purchase of medical devices.
The same provision prohibits the encouraging of healthcare professionals to replace one medical device with another without a clear medical indication.
The Law on Healthcare (Official Gazette of the Republic of Serbia, Nos. 25/2019, 92/2023 – Authentic Interpretation, and 29/2025 – Constitutional Court Decision, Zakon o zdravstvenoj zaštiti, “Law on Healthcare”) further addresses conflicts of interest under Article 234, which defines a conflict of interest by reference to situations in which a healthcare professional’s private interests affect, may affect, or appear to affect the impartial and objective performance of professional duties.
The same provision establishes specific restrictions applicable to healthcare professionals employed by publicly owned healthcare institutions, including restrictions on accepting financial or other benefits that could compromise their impartiality or be perceived as a reward for performing their duties.
The precise application of these provisions depends on the circumstances of the engagement and should be assessed in concreto against the applicable legislation and any relevant professional or institutional requirements.
Penalties for Non-Compliance
The Law on Medical Devices establishes a specific sanctions regime for breaches of the rules governing the advertising and promotion of medical devices, including the restrictions set out in Articles 112 and 113.
Pursuant to Article 126, paragraph 1, item 7 of the aforementioned law, a legal entity that promotes medical devices in breach of the applicable statutory requirements may be fined between RSD 1,500,000 and RSD 3,000,000 for an economic offence. In addition while the responsible person within the legal entity may be fined between RSD 100,000 and RSD 200,000. Under Article 128, paragraph 1, item 7 of the Law, entrepreneurs may be subject to fines ranging from RSD 300,000 to RSD 500,000.
Article 127 of the Law om Medical Devices further provides that legal entities may be prohibited from carrying out certain business activities for a period of three to ten years. This law also mandates the confiscation of objects used or intended for the commission of the economic offence, or resulting from it.
Importantly, the mere engagement or remuneration of a healthcare professional does not, in itself, constitute a violation of these provisions. The relevant compliance risk arises where an arrangement, assessed in light of its actual purpose and implementation, amounts to prohibited promotional activity or an inducement to prescribe, procure, recommend, use or purchase medical devices.
Accordingly, genuine consultancy, educational or other professional services should be supported by a legitimate business need, clearly defined deliverables, proportionate remuneration and appropriate evidence of performance. Such arrangements must not serve as a disguised mechanism for rewarding or influencing healthcare professionals’ independent decisions.
Can Healthcare Professionals Be Engaged as Consultants?
Serbian law does not appear to impose a general prohibition on healthcare professionals providing genuine consultancy or other professional services to medical device manufacturers and/or distributors. Whether a particular collaboration is permissible depends, however, on its actual purpose, content, and manner of implementation, as well as on the requirements applicable to the health professional in question.
Legitimate engagements may include educational activities, professional training, technical assistance on designing, manufacture and maintain or related to the proper use of the medical devices, market research and the preparation of expert assessments. Such activities must address a genuine professional or business need and must not be used as a means of improperly influencing clinical or purchasing decisions.
However, the legal permissibility of such arrangements cannot be established solely by concluding a consultancy agreement. The underlying services must have a legitimate purpose, be clearly defined and actually performed. The remuneration should reflect the nature, complexity and scope of the services provided.
Particular attention should be drawn to arrangements involving healthcare professionals who are in a position to influence the prescription, recommendation or procurement of the company’s products. A consultancy agreement must not be used as a formal mechanism for providing financial benefits in exchange for favourable treatment of particular medical devices.
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