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MDR Medizinproukte-VO
Spezialisierungen
Medizinrecht
Alle gemäß den Artikeln 38 und 39 erforderlichen Unterlagen werden in einer oder mehreren von dem betreffenden Mitgliedstaat festgelegten Sprachen erstellt.
Die Mitgliedstaaten tragen bei Anwendung von Absatz 1 der Überlegung Rechnung, dass für die betreffenden Unterlagen oder Teile davon eine in medizinischen Kreisen allgemein verstandene Sprache akzeptiert und verwendet werden sollte.
Die Kommission stellt die Übersetzungen der Unterlagen gemäß den Artikeln 38 und 39 oder von Teilen dieser Unterlagen in eine Amtssprache der Union bereit, die erforderlich sind, damit diese Unterlagen für das gemäß Artikel 39 Absatz 3 bestellte gemeinsame Bewertungsteam leicht zu verstehen sind.
Quelle: EURLEX
Import: