CYMDA announcement of 6 November 2025

ΑΝΑΚΟΙΝΩΣΗ ΓΙΑ ΤΗΝ ΑΝΑΓΡΑΦΗ ΤΩΝ ΣΤΟΙΧΕΙΩΝ ΤΟΥ ΕΙΣΑΓΩΓΕΑ ΣΤΑ ΙΑΤΡΟΤΕΧΝΟΛΟΓΙΚΑ ΠΡΟΪΟΝΤΑ ΚΑΙ ΑΛΛΕΣ ΥΠΟΧΡΕΩΣΕΙΣ ΔΙΑΝΟΜΕΩΝ/ΕΙΣΑΓΩΓΕΩΝ, dated 6 Νοεμβρίου 2025, in three numbered parts. Part 1 restates the Annex I para. 23.1 MDR / para. 20.2 IVDR labelling duty and names the three importer details that must appear on the device, its packaging or an accompanying document (name or registered trade name or trade mark; registered place of business; address), the rule that added labelling must not cover the manufacturer’s information, and the distributor’s verification duty. Part 2 sets out the general obligations of importers and distributors under Articles 13 and 14 and the four additional obligations the Regulations introduce: registration in EUDAMED (Art. 31(1) MDR / 28(1) IVDR), the importer acting as manufacturer (Art. 16 of each), traceability (Art. 25 MDR / 22 IVDR) and the class III implantable-device obligations (Art. 28(8) MDR), and points to MDCG 2021-27. Part 3 is the notification duty: under Decree No. 7 of 5 January 2012 importers and distributors must notify devices they place on the Cypriot market to the Authority, per operator and independently of any other operator’s notification. The notice records that the Authority has so far imposed no additional requirement beyond Union and national law. It defines importation as coming from outside the EU/EEA — Switzerland included, Turkey excluded — so intra-EEA movement is distribution, not importation. No reference number is printed.

CYMDA announcement of 6 November 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.