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Ministry of Health CYMDA

CYMDA announcement of 24 March 2026

Language requirements for medical devices and in-vitro diagnostic devices
CyprusMinistry of HealthLabeling
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CYMDA announcement of 24 March 2026 is the official CYMDA identifier for “Language requirements for medical devices and in-vitro diagnostic devices”. CYMDA announcement of 24 March 2026 is the official identifier CYMDA uses for this instrument.

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CYMDA
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CYMDA announcement of 24 March 2026
Category
Labeling
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Greek
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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0 articles · 1 language version
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Dates
Published
March 24, 2026
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About this regulation

Language requirements for medical devices and in-vitro diagnostic devices

ΑΝΑΚΟΙΝΩΣΗ ΓΙΑ ΓΛΩΣΣΙΚΕΣ ΑΠΑΙΤΗΣΕΙΣ ΙΑΤΡΟΤΕΧΝΟΛΟΓΙΚΩΝ ΚΑΙ IN-VITRO ΔΙΑΓΝΩΣΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ, dated 24 Μαρτίου 2026. Three numbered points: (1) under Decree No. 6 made under Article 59(1)(ζ) of the Basic Requirements Laws 2002–2011, the information required for the safe and proper use of a device must be supplied in English and/or Greek; (2) for devices intended for use by non-professional users that information must also be supplied in Greek without exception; (3) instructions for use must meet the relevant requirements of Regulations (EU) 2017/745 and 2017/746. The closing paragraphs state that placing products on the market that do not comply is prohibited, for importers, distributors, pharmacies, retail points of sale and online sellers alike, and that the Authority may impose administrative measures and/or fines under Law 225(I)/2022 on market surveillance. The announcement carries no reference number; the date is the only identifier it prints.

CYMDA announcement of 24 March 2026 is the official identifier CYMDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.