CInMED „Službeni„Službeni list Crne Gore“ br. 024/19, 084/24
„Službeni list Crne Gore“ br. 024/19, 084/24 is the official CInMED identifier for “Zakon o medicinskim sredstvima (Law on Medical Devices) — prečišćeni tekst”. „Službeni list Crne Gore“ br. 024/19, 084/24 is the official identifier CInMED uses for this instrument.
- Instrument
- „Službeni
- Full name
- „Službeni list Crne Gore“ br. 024/19, 084/24
- Category
- Registration
- Authority source
- Montenegrin
- Readable HTML
- 145 articles · 1 language version
- Published
- April 22, 2019
- Effective
- October 1, 2024
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Zakon o medicinskim sredstvima (Law on Medical Devices) — prečišćeni tekst
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.
„Službeni list Crne Gore“ br. 024/19, 084/24 is the official identifier CInMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.