Bosnia and Herzegovina medical device regulations

The Agency’s instruction of 27 August 2025 (marked „NOVO“ on the served copy) on the conditions and manner of recognising a manufacturer’s Declaration of Conformity during the move from Directive 93/42/EEC to Regulation (EU) 2017/745 — the companion to the EC-certificate instruction of 6 February 2025, covering the class I and other devices that reach the market on the manufacturer’s own declaration rather than on a notified-body certificate. It is likewise written on Article 120 of Regulation (EU) 2017/745 as amended by Regulations (EU) 2020/561 and (EU) 2023/607. The extract keeps the instruction’s own numbering: the preamble states the legal basis, item 1 covers devices classified as class I risk and the case where the Regulation does not require a notified body, item 2 covers class I devices whose class changes under the Regulation, and item 3 covers the higher risk classes (Is, Im, IIa, IIb, III and AIMD) for which a Declaration of Conformity has been issued.

The Sektor za medicinska sredstva’s documentation list of 30 October 2025 for amending or supplementing an existing entry in the register — the counterpart to MSU-1.2 for changes rather than first registration. The list is organised the way the Agency’s change form is: a head entry, DOPUNA UPISA U REGISTAR MEDICINSKIH SREDSTAVA; then one numbered tačka per change type on the application — 1 change of the manufacturer’s name or address, 2 change of the name or address of the holder of the entry certificate, 3 change of the holder itself, 4 change of the device’s name, 5 change of the manufacturer, 6 change or addition of a manufacturing site, 7 change of the finished-product test procedure (change of standard or method), 8, 9 change or supplement of the device’s shape, packaging or dimensions, 10, 11 change of the shelf life, 12 change of the storage conditions, 13 change of the manner and place of supply, 14 other changes; then the four lettered subdivisions of „other changes“ — a) the instructions for use, b) the EC certificate of conformity where the change requires it, c) the device’s catalogue number, d) documentation already filed on registration; and finally the Agency’s own „Napomene vezane za zahtjeve za izmjenu i dopunu upisa“. Two of the numbered heads (tačka 8 and tačka 10) carry no printed caption in the source and are ingested with their number only rather than an invented title.

The Agency’s instruction of 6 February 2025 on the conditions and manner of recognising an EC certificate of conformity during the move from the EU directives (MDD/AIMD) to Regulation (EU) 2017/745. It is written expressly on Article 120 of Regulation (EU) 2017/745 as amended by Regulations (EU) 2020/561 and (EU) 2023/607 — the transitional provision — so although Bosnia and Herzegovina is not an EU member State, the Agency reads the Union transitional period across: an EC certificate issued by a notified body under Directives 90/385/EEC or 93/42/EEC is recognised for the devices and until the dates the instruction sets out. The extract keeps the instruction’s own numbering: the preamble states the legal basis and Article 120, item 1 states which EC certificates are recognised, and item 2 carries the market and putting-into-service dates and the conditions attached to them.

Section 2, „Potrebna dokumentacija za upis medicinskog sredstva u Registar“, of the Agency’s instruction to applicants MSU-1.2 (izdanje 0.9.2) — the operative statement of what must be filed for a device to be entered in the ALMBIH register, issued under Articles 68 and 69(2) of the Pravilnik o medicinskim sredstvima. The documentation is filed in one registrator in four colour-separated parts, and the extract keeps the Agency’s own division: A Prvi dio — Zahtjev, autorizacija i takse; B Drugi dio — Polisa i ISO sertifikati; C Treći dio — Specifični podaci o medicinskom sredstvu; D Četvrti dio — Opšti i tehnički podaci o medicinskom sredstvu. The served PDF is the whole 37-page MSU-1.2 instruction, and only section 2 (pages 11 to 12 of 37) is ingested, because that is the part the round-207 recommendation named and the part that carries the register’s documentary requirements; the surrounding sections are the instruction’s own administrative front matter.

Pravilnik o medicinskim sredstvima, made by the ministar civilnih poslova on the proposal of the Stručno vijeće of the Agencija za lijekove i medicinska sredstva BiH, signed 10 December 2009 and published in „Službeni glasnik BiH“ br. 4/10 of 19 January 2010. It is issued under Article 99(7), Article 100(4), Article 106(5), Article 112(3) and Article 113(4) of the Zakon o lijekovima i medicinskim sredstvima, so the issuer is the ministry and the Agency is the proposer — the registry regulator label is used for the row and the distinction is stated here. In twelve parts and 92 articles, with five annexes: I Osnovne odredbe; II Klasifikacija i razvrstavanje medicinskih sredstava; III Pravila za razvrstavanje medicinskih sredstava, itself in four glavas (I Opšte o pravilima, II Neinvazivna, IV Aktivna, V Posebna pravila); IV Registar medicinskih sredstava; V Proizvodnja; VI Ispitivanje; VII Utvrđivanje usklađenosti i označavanje, in two glavas (I Opšte, III Označavanje i izjava o usklađenosti); VIII Kategorije medicinskih sredstava; IX Uslovi za upis u registar, the part the ALMBIH MSU-1.2 documentation list is read against; X Promet; XI Oglašavanje; XII Prijelazne i završne odredbe. Annexes: Prilog 1 and Prilog 2 (classification rules tables), the OBRAZAC REG-IV-MS registration application form (Prilog 3), Prilog 4 and Prilog 5. **The printed instrument’s own part and glava numbering has gaps** — DIO TREĆI runs GLAVA I, II, IV, V (no GLAVA III) and DIO SEDMI runs GLAVA I and III (no GLAVA II) — and the block ids follow the part rather than a dense renumbering, so the missing glava numbers remain visible rather than being silently closed up. Ingested from the ALMBIH PDF of the gazette, with reading order and the legacy character set restored.

Zakon o lijekovima i medicinskim sredstvima Bosne i Hercegovine, adopted by the Parlamentarna skupština BiH (PSBiH broj 217/08 of 17 June 2008), published in „Službeni glasnik BiH“ br. 58/08 of 21 July 2008. It is the state-level framework statute for both medicines and medical devices, and Chapter IV (Medicinska sredstva, Articles 96 to 123) is the device part: Article 96 defines a medical device and excludes the medicinal-product, transplant, blood and tissue cases; the chapter then covers the classification and conformity-assessment duties, the register of medical devices, manufacture, clinical investigation, vigilance, advertising and the disposal of devices taken out of use. The **scope of this ingest differs from the round-207 triage note**, which described the document as „Poglavlje IV. Medicinska sredstva, članovi 96–129“: the bytes ALMBIH serves are the 26-page gazette excerpt of the **entire** statute as printed — Chapters I to VII, Articles 1 to 142 — and Chapter IV runs from Article 96 to Article 123, because Article 124 already opens Chapter V (Farmaceutsko-inspekcijski nadzor). The whole statute is therefore ingested, not the chapter, and the chapter boundary is recorded here as the print states it. Parts: I Osnovne odredbe; II Agencija za lijekove i medicinska sredstva Bosne i Hercegovine, which constitutes the Agency; III Lijekovi; IV Medicinska sredstva (Arts. 96–123); V Farmaceuts ko-inspekcijski nadzor; VI Prekršajne odredbe; VII Prijelazne i završne odredbe. Ingested from the ALMBIH PDF of the gazette, with reading order restored from the two-column setting and the legacy pre-Unicode Bosnian character set mapped back to its letters.