ALMBiH UputstvoUputstvo od 06.02.2025
Uputstvo od 06.02.2025 is the official ALMBiH identifier for “Uputstvo o uslovima i načinu priznavanja sertifikata o usaglašenosti medicinskih sredstava (EC sertifikat) usljed prelaska EU direktiva (MDD/AIMD) na EU regulativu (MDR)”. Uputstvo od 06.02.2025 is the official identifier ALMBiH uses for this instrument.
- Instrument
- Uputstvo
- Full name
- Uputstvo od 06.02.2025
- Category
- Registration
- Authority source
- Bosnian
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Uputstvo o uslovima i načinu priznavanja sertifikata o usaglašenosti medicinskih sredstava (EC sertifikat) usljed prelaska EU direktiva (MDD/AIMD) na EU regulativu (MDR)
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.
Uputstvo od 06.02.2025 is the official identifier ALMBiH uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.