PART III - RULES FOR CLASSIFICATION OF MEDICAL DEVICES
TITLE I - GENERAL RULES

The process of establishing the conformity of the medical device with general and special requirements depends on the classification of the medical device according to the degree of risk, namely:

a) for Class I medical devices - manufacturer itself assesses the compliance of the product with the general and specific requirements and, on their own responsibility, makes a statement or certificate based on that. Exceptions are class I medical devices that are used to measure and sterile products that are adjusted, which are treated as medical devices from class IIa, IIb and III for determining their ability to measure or sterility;

b) for medical devices from class IIa, IIb and III - the competent institution determines the compliance of medical devices with the prescribed general and special requirements, as well as the supervision of the quality assurance system.

Refer Article 37

The technical documentation that should enable the conformity of the medical device, which contains the following information:

a) a general list of medical devices, design specifications, including standards that are used and the result of the risk analysis;
b) plan's design, description of production processes, description of components and auxiliary parts of the medical device;
c) the responsibility of leading personnel and its competencies during the development of a medical device;
d) methods of monitoring of applied quality system;
e) a description of the methods of sterilization in the case of sterile products and test results;
f) proof that the medical device meets the essential requirements in the case when it is connected to other medical product with the characteristics specified by the manufacturer;
g) clinical data when required in accordance with this Ordinance;
h) labeling and instructions for use.

Every medical device that is marketed in Bosnia and Herzegovina should be labeled as such on the outer and the immediate packaging in one of the official languages in BiH and have attached instructions for use.

Refer Artile 38 and 53 for more infomation

Article 16 (The costs relating to the registration, amendment and re-registration of medical devices in the register of medical devices)

The deadlines for reporting of the adverse reactions related to medical devices are:

• for serious threat to public health: IMMEDIATELY, no later than two days after the manufacturer has become aware of the threat
• for patient’s death or unexpected serious deterioration of patient’s health condition: IMMEDIATELY, no later than ten days after the manufacturer of the medical device has detected connection between medical device and adverse event;
• for other adverse reactions: IMMEDIATELY, no later than thirty days after manufacturer of the medical device has established connection between medical device and adverse event

• That there is suspicion of its connection to medical device;
• That adverse effect has caused or could cause patient’s death or deterioration of patient’s, user’s or any other person’s health conditions

The marketing of the medicinal product authorization shall be issued for a period of 5 years.