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CInMED, dokument Za740.01-05-IMS (18.06.2025)

Način priznavanja deklaracija o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktiva MDD/AIMD na regulativu MDR (EU) 2017/745
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CInMED, dokument Za740.01-05-IMS (18.06.2025) is the official CInMED identifier for “Način priznavanja deklaracija o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktiva MDD/AIMD na regulativu MDR (EU) 2017/745”. CInMED, dokument Za740.01-05-IMS (18.06.2025) is the official identifier CInMED uses for this instrument.

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CInMED, dokument Za740.01-05-IMS (18.06.2025)
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Način priznavanja deklaracija o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktiva MDD/AIMD na regulativu MDR (EU) 2017/745

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, dokument Za740.01-05-IMS (18.06.2025) is the official identifier CInMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.