Cyprus medical device regulations

Cyprus is an EU member State, so Regulation (EU) 2017/746 applies directly; as with the MDR there is no Cypriot instrument restating it. The text is expressed once in eu.ts as eu-ivdr-2017-746; this row is the Cypriot metadata view onto it and opens the articles CYMDA’s notices apply: manufacturer obligations (Art. 10), importer and distributor obligations (Arts. 13 and 14) and EUDAMED registration (Arts. 27 to 29). It is not a second corpus copy.

Cyprus is an EU member State, so Regulation (EU) 2017/745 applies directly and is the only retrievable official expression that carries the device obligations a customer asks about — there is no Cypriot instrument that restates them. The text is expressed once in eu.ts as eu-mdr-2017-745; this row is the Cypriot metadata view onto it and opens the articles CYMDA’s notices apply: manufacturer obligations (Art. 10), importer and distributor obligations (Arts. 13 and 14), EUDAMED registration (Arts. 30 and 31) and vigilance (Art. 87). It is not a second corpus copy.

Ανακοίνωση of 8 Ιανουαρίου 2026 on the compulsory use of four EUDAMED modules from 28 May 2026. It records that Commission Implementing Decision (EU) 2025/2371 makes the first four functional modules mandatory from that date: actor registration (Art. 30 MDR / 27 IVDR), the UDI database and device registration (Art. 28–29 MDR / 25–26 IVDR), notified bodies and certificates (Art. 57 MDR / 52 IVDR) and market surveillance (Art. 100 MDR / 95 IVDR). Economic operators — manufacturers, authorised representatives and importers — must register in the actor module in good time; manufacturers must register their devices in the UDI and device modules and notified bodies must attach their certificates in the notified bodies and certificates module. The notice gives the EUDAMED landing-page link and the Commission pages carrying the explanatory material and Q&A. No reference number is printed.

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.

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.

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.

Union instrument, expressed once in eu.ts as eu-regulation-2023-607. This Cypriot row is a metadata view onto that expression; it is the instrument that extended the MDR transitional periods for devices covered by a valid Directive 90/385/EEC or 93/42/EEC certificate (Article 120(3a) to (3f)) and the corresponding IVDR period (Article 110(4)), which is what Cypriot certificate holders read the deadlines from. It is not a second corpus copy.

Union instrument, expressed once in eu.ts as eu-regulation-2024-1860. This Cypriot row is a metadata view onto that expression. It is the instrument behind the EUDAMED module timetable CYMDA’s announcement of 8 January 2026 applies — it inserted Article 10a MDR/IVDR on supply-interruption notification, revised Article 34 and Article 78(14) MDR and the IVDR equivalents, and extended the IVDR transitional period in Article 110(3). It is not a second corpus copy.