Ministry of Health CYMDACYMDA announcement of 30 July 2025
CYMDA announcement of 30 July 2025 is the official CYMDA identifier for “Reporting of incidents arising from the use of medical devices and in-vitro diagnostic devices”. CYMDA announcement of 30 July 2025 is the official identifier CYMDA uses for this instrument.
- Instrument
- CYMDA
- Full name
- CYMDA announcement of 30 July 2025
- Category
- Vigilance
- Authority source
- Greek
- Readable HTML
- 0 articles · 1 language version
- Published
- July 30, 2025
- Effective
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Reporting of incidents arising from the use of medical devices and in-vitro diagnostic devices
ΑΝΑΚΟΙΝΩΣΗ ΠΡΟΣ ΕΠΑΓΓΕΛΜΑΤΙΕΣ ΥΓΕΙΑΣ ΓΙΑ ΤΗΝ ΑΝΑΦΟΡΑ ΠΕΡΙΣΤΑΤΙΚΩΝ ΚΑΤΑ ΤΗΝ ΧΡΗΣΗ ΙΑΤΡΟΤΕΧΝΟΛΟΓΙΚΩΝ ΠΡΟΪΟΝΤΩΝ ΚΑΙ IN VITRO ΔΙΑΓΝΩΣΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ, dated 30 Ιουλίου 2025, addressed to health professionals as users, in three headed sections. "Αναφορά στους κατασκευαστές" recalls the MDR/IVDR post-market surveillance duty and defines what counts as an incident, problem or complaint — any event affecting the functioning, performance or safety of a product, including malfunction, inaccurate results (particularly for IVDs), premature wear or any unexpected behaviour that may endanger patients or users — and recommends that health professionals, quality units and procurement departments establish communication mechanisms in advance. "Ταυτοποίηση προϊόντος κατά την επικοινωνία περιστατικού και υποχρεώσεις προμηθευτών MDs/IVDs" lists the identifying data to supply (trade name, serial number, UDI, model, lot, batch, manufacturing and expiry dates) and the supplier’s record-keeping and manufacturer-notification duty under Art. 13(6)/14(5). "Αναφορά στην Αρμόδια Αρχή" gives the two routes to the Authority: the Medical-Devices-Adverce-Incident-User-Report-Form by email, or the Microsoft Forms online form. No reference number is printed.
CYMDA announcement of 30 July 2025 is the official identifier CYMDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.