Montenegro medical device regulations

The consolidated text (prečišćeni tekst) of the Zakon o medicinskim sredstvima, made up of the original law of 22 April 2019 („Službeni list Crne Gore“ br. 024/19) and the 2024 amendment act on inspection supervision (br. 084/24 of 6 September 2024). The publisher’s own note at the head of the text states that this consolidated text applies from 1 October 2024, which is the effective date recorded here; the amendment date is the date of the amending act. In fourteen chapters and 144 articles plus a transposition footnote: I Osnovne odredbe; II Nadležnosti; III Klasifikacija medicinskih sredstava; IV Zahtjevi koje moraju da ispune medicinska sredstva; V Registracija medicinskog sredstva, the chapter the registration rulebook and the 2026 applicants’ guide are read against; VI Proizvodnja; VII Promet; VIII Obilježavanje; IX Klinička ispitivanja; X Vigilanca, praćenje i nadzor medicinskih sredstava u prometu; XI Oglašavanje; XII Nadzor; XIII Kaznene odredbe; XIV Prelazne i završne odredbe. **The printed consolidated text skips Član 145** — the headings run 1 to 144 and then 146 — and the block ids keep the printed numbers rather than closing the gap, so the missing article is visible as a gap instead of being silently renumbered. The statute transposes the pre-MDR Union directives and says so itself: the transposition footnote at the foot of the text lists Directive 93/42/EEZ, Directive 90/385/EEZ, Directive 98/79/EZ, Directive 2000/70/EZ, Directive 2001/104/EZ, Directive 2007/47/EZ and Directive 93/68/EEZ, and is carried verbatim as the extract’s `annex-eu-transposition` block. Regulation (EU) 2017/745 and 2017/746 are therefore **not** the basis of this statute, and the Montenegrin position on them is stated in the two CInMED notices of 18 June 2025 recorded below.

The in-vitro counterpart to the MDR notice, issued the same day under the same document number: CInMED’s notice of 18 June 2025 on how a declaration of conformity and EC certificates are recognised in the Institute’s procedures during the alignment on the move from EU Directive 98/79/EZ (IVDD) to Regulation (EU) 2017/746. It matters more in Montenegro than its device sibling because the statute’s transposition footnote lists the IVDD generation and nothing later, so an IVD certificate’s standing in the register is entirely a matter of this notice. In three numbered items; unlike the MDR notice it carries no starred annex, and the extract ends with item 3. No publication date is stated on the document; the 18 June 2025 revision date carried in its own document number and title is the date recorded here.

CInMED’s notice of 18 June 2025 (document Za740.01-05-IMS) on how declarations of conformity and EC certificates are recognised in the procedures the Institute conducts during the period in which the national legislation is being aligned on the move from the EU directives MDD/AIMD to Regulation (EU) 2017/745. It is the operative Montenegrin statement of what a manufacturer must file in the transition, and it is a national document about the Union regime, not a view onto a Union text: the Zakon o medicinskim sredstvima still transposes the directives, so the recognition of EC certificates is a matter of Montenegrin administrative practice and had to be published by the Agency. In three numbered items, followed by a starred annex on the manner of recognising EC certificates in the procedures before the Institute — `* NAČIN PRIZNAVANJA EC SERTIFIKATA U POSTUPCIMA KOJI SE VODE PRED INSTITUTOM`, carried as its own `annex-ec-certificates` block. No publication date is stated on the document; the 18 June 2025 revision date carried in its own document number and title is the date recorded here.

CInMED’s guide to applicants for the registration of a medical device, revised 18 March 2026 — the current checklist of what must be filed, and therefore the working document an applicant reads alongside the 2022 registration rulebook. In eleven numbered items covering the application, the accompanying documentation, the form of the documents and the language and certification requirements, followed by the Agency’s two general conditions after the receipt of an application (`Nosilac upisa je dužan …`, carried as `body-closing-conditions`), the starred note on how documents are to be supplied (`*Dokumenta dostaviti u papirnom ili elektronskom obliku`, `note-starred`) and the closing `NAPOMENA` on the transitional periods for a device that is not yet aligned with the new regulations (`note-transition`). The served PDF carries literal `**` markers around its own bold title in the text layer; they are stripped rather than ingested as content. No publication date is stated; the 18 March 2026 revision date in the document’s own number and title is the date recorded here.

Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, published in „Službeni list Crne Gore“ br. 035/23 of 27 March 2023. It is made by the Upravni odbor Instituta za ljekove i medicinska sredstva Crne Gore — the Agency’s governing board, not the Agency itself and not the ministry — which is why that body is named as the publisher on this row rather than the registry regulator. In seven articles setting the fees for the professional services the Institute performs on devices, followed by the published act’s own explanatory note (OBRAZLOŽENJE), which is part of the act as gazetted and is carried in its four printed sections: I PRAVNI OSNOV, II RAZLOZI ZA DONOŠENJE, III IZJAVA O USAGLAŠENOSTI SA PRAVNOM TEKOVINOM EVROPSKE UNIJE and IV PROCJENA FINANSIJSKIH SREDSTAVA ZA SPROVOĐENJE PROPISA. The OBRAZLOŽENJE is where the figures are recoverable, and it matters here: **the two fee tables in Articles 2 and 3 (pages 2 to 4 of the served PDF) are page images with no text layer**, so the amounts themselves are not in the extract; what the extract does carry is the explanatory note’s prose account of the changes — for example the increase to 200–300 EUR for class IIb devices, import approvals rising from 60 to 250 EUR, annual maintenance at 80–100 EUR and vigilance fees of 10 to 45 EUR, with the stated increases of 66.7%, 50%, 42.9%, 33.3%, 20%, 14.3%, 16.7%, 2.9% and 6.7% by fee line. No OCR was applied: the scan is in Montenegrin and the installed OCR language packs cover no South Slavic language, so recognising the tables would have required inventing diacritics.

Pravilnik o priznavanju inostranih isprava i CE znaka i o registraciji medicinskog sredstva, published in „Službeni list Crne Gore“ br. 085/22 of 2 August 2022 and amended by br. 126/22 of 18 November 2022, ingested as the Katalog propisa consolidated text. It is the registration rulebook under Chapter V of the Zakon o medicinskim sredstvima: thirteen articles on the recognition of foreign documents and the CE mark and on the registration of a device, from Predmet (Art. 1) through the documentation filed with a registration application (Art. 10), the grounds for refusal and deletion, to the entry into force. The Katalog propisa copy is a service’s reproduction of the Službeni list text rather than the gazette’s own bytes, which is why the publisher recorded on the row is the consolidated-text service. **The four annexed Obrasci (the application, the declaration and the two supporting forms, pages 5 to 16 of 16) are page images with no text layer at all**, so the extract carries the rulebook’s own thirteen articles and the publisher’s NAPOMENA IZDAVAČA rather than the forms; that note is itself the document’s own statement that the annexes are served only as images („Priloge … možete pogledati ovdje“), and it is kept verbatim as the extract’s `note-publisher` block instead of being paraphrased.