ALMBiH UputstvoUputstvo od 27.08.2025
Uputstvo od 27.08.2025 is the official ALMBiH identifier for “Uputstvo o uslovima i načinu priznavanja Izjave proizvođača o usklađenosti medicinskog sredstva („Declaration of Conformity“) usljed prelaska EU direktiva (MDD) na EU regulativu (MDR)”. Uputstvo od 27.08.2025 is the official identifier ALMBiH uses for this instrument.
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- Uputstvo
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- Uputstvo od 27.08.2025
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- Registration
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- Bosnian
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Uputstvo o uslovima i načinu priznavanja Izjave proizvođača o usklađenosti medicinskog sredstva („Declaration of Conformity“) usljed prelaska EU direktiva (MDD) na EU regulativu (MDR)
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.
Uputstvo od 27.08.2025 is the official identifier ALMBiH uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.