3 Things Persons Responsible for Medical Devices Regulatory Compliance Will Not Find in Law


3 Obligations of the Responsible Person for the Distribution of Medical Devices That You Will Not Find in the Law


The distribution of medical devices in the Republic of Serbia is an area that is regulated by a series of complex regulations, which often leads to errors in their interpretation and application. Particular challenges in practice arise when obligations are prescribed by different, but interrelated, regulations.

If you want to avoid difficulties when interpreting and applying regulations, then you are in the right place, because in the following text you will find clear and simple explanations of what you need to know if you are the person responsible for the sale of medical devices.

It is often challenging to understand the obligations prescribed by individual regulations, especially when the implementation is intertwined through several regulations. And what is not written in the law?

Responsible person – expert or interpreter of regulations?

At this point we come to the essence of this text. The law and relevant regulations prescribe a number of conditions for someone to be appointed as a responsible person of the manufacturer, representative of the manufacturer or wholesaler. When the responsible person possesses all the prescribed characteristics and references, only one remains, which is not prescribed but is mandatory. That characteristic of the responsible person is of essential importance, and it can have a decisive influence on the business of the entity in the medical devices industry.

The responsible person, in addition to technical knowledge and experience in the profession, must have a sense for mapping, systematization and correct and practical interpretation of relevant regulations! Otherwise, there is a justified fear that failure to interpret and properly apply regulations will have negative implications in the form of corrective or preventive measures against the subject. Every regulatory derailment produces unforeseen business and economic consequences.

It can be vitally important that the responsible person, in addition to the sense for the application and interpretation of regulations, has a demonstrated inclination towards organization, systematization and rationalization of both internal and external professional and business processes.

One or more responsible persons?

Following on from the previous statement, if in accordance with the legal requirements there are several responsible persons for the sale of medical devices, it is important that there is coordination and clearly structured cooperation between them. The characters of team players can have a decisive impact on business and economic growth and further development, especially in the highly regulated industry of medical devices.

Both form and substance

Due to all of the above, the responsible person, in addition to the formal conditions, must also fulfill the essential conditions, without which it will be difficult to create the conditions for the subject’s business to be formally harmonized with the law.

P.S. It should always be kept in mind that regulations from the medicine and medical device industry are aimed at protecting public health. Any violation of it will result in a rigid response from the state administration and media sensationalism.


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