Free Bosnia and Herzegovina medical device classification tool

What the Bosnia and Herzegovina classifier checks

How are medical devices classified in Bosnia and Herzegovina?

ALMBiH uses a risk-based framework. Possible classes include IVDs: List D — all other in vitro diagnostic devices, List C — devices for self-diagnosis, List B — professional-use devices named in the list, List A — professional-use devices named in the list; Medical devices: Class I, Class II-a, Class II-b, Class III. In vitro diagnostic medical devices are classified on a separate, legacy axis. Čl. 99(4) of the Law divides them into devices used only by professional staff, which are themselves split into list A and list B, devices for self-diagnosis, and all other in vitro diagnostic devices; čl. 4(4) of the Pravilnik formalises those four as lista A, lista B, lista C (self-testing) and lista D (all others), and čl. 5(3) sets out the contents of each list — list A covering ABO, rhesus and the antibody panel together with reagents for detecting and quantifying HIV 1 and 2, HTLV 1 and 2 and hepatitis B, C and D; list B covering anti-Duffy and anti-Kidd, irregular anti-erythrocyte antibodies, rubella and toxoplasmosis, phenylketonuria, cytomegalovirus and chlamydia, HLA tissue groups, PSA and trisomy 21 risk; list C covering self-testing devices and their accessories; and list D covering everything else. List A is the highest-risk list and list D the residual one. These lists are recorded in the single state Register of medical devices administered by ALMBIH, and the same čl. 65(8) entry right applies. The class axis of the state Law on Medicines and Medical Devices, not the EU MDR. Čl. 99(1) of the Zakon o lijekovima i medicinskim sredstvima grades medical devices into Class I (low), Class II-a (higher), Class II-b (high) and Class III (highest) risk, and čl. 99(2), (3), (5) and (6) add nature, duration of use, dispensing channel and combination-product axes; čl. 101 makes the conformity-assessment route depend on that class — self-assessment with a manufacturer's declaration for Class I, except devices with a measuring function and sterile products, which are handled as Class II or III, and authorised institutions for Class II-a, II-b and III, with the Agency's Commission for Medical Devices taking over where no authorised institution exists. Čl. 102(3) requires a manufacturer whose conformity is determined by a conformity-assessment body recognised in the EU to affix the CE marking recognised in BiH, and the Agency's Instruction of 6 February 2025 sets out how an EC certificate issued under Directives 90/385/EEC and 93/42/EEC is recognised. Recognising that certificate is an administrative act of ALMBIH, not an application of Regulation (EU) 2017/745: the device is still entered in the Agency's register, which by čl. 65(8) of the Pravilnik is what confers the right to place it on the market of Bosnia and Herzegovina. Authority for the register sits with the STATE agency, not with the entities: čl. 8(a) of the Law gives the Agency the register of medical devices 'za teritoriju BiH', čl. 108(2) forbids marketing any device not entered in that register, and the entities and Brčko District prescribe only the conditions on premises, equipment and personnel under čl. 104(2). The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.

What information does the Bosnia and Herzegovina classifier use?

Current ALMBiH requirements and class information from similar registered products. Your result includes an explanation and links to the official sources used.

Is the result an official ALMBiH classification decision?

No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.