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

Način priznavanja deklaracije o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktive IVDD na regulativu IVDR (EU) 2017/746
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CInMED, dokument Za740.01-05-IMS (18.06.2025) is the official CInMED identifier for “Način priznavanja deklaracije o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktive IVDD na regulativu IVDR (EU) 2017/746”. CInMED, dokument Za740.01-05-IMS (18.06.2025) is the official identifier CInMED uses for this instrument.

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CInMED,
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CInMED, dokument Za740.01-05-IMS (18.06.2025)
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Način priznavanja deklaracije o usaglašenosti i EC sertifikata u postupcima koji se vode pred Institutom — prelazak sa EU direktive IVDD na regulativu IVDR (EU) 2017/746

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, 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.