Cyprus medical device regulatory resources

CYMDA is the designating and supervising authority for notified bodies established in Cyprus

CYMDA is the designating and supervising authority for the notified bodies established in the Republic of Cyprus, and is responsible for enforcing the requirements of Regulations (EU) 2017/…

The Cyprus Medical Devices Authority (CYMDA) is the competent authority for medical devices and IVDs

The competent Cypriot government authority for medical devices and in vitro diagnostic medical devices is the Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού — the Cyprus Medical Devices Authorit…

Cypriot instruments listed by CYMDA: the 2002–2013 basic-requirements laws and their 2003–2013 regulations

CYMDA's legislation page lists the Cypriot instruments adopted for harmonisation with the acquis: the Basic Requirements laws on specified categories of products (Οι περί των Βασικών Απαιτή…

The governing law is Regulation (EU) 2017/745 and Regulation (EU) 2017/746, applied directly

Cyprus is an EU Member State, so Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are binding in their entirety and directly applicable. CYMDA describes itself as the comp…

Cyprus applies the Union device definition and extends the MDR to Annex XVI products without an intended medical purpose

Cyprus applies the Union definitions directly. CYMDA's definitions page reproduces the medical device definition of Article 2(1) of Regulation (EU) 2017/745 and the in vitro diagnostic medi…

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

Decree No. 7 requires Cypriot manufacturers, importers and distributors to notify their seat address and device list to CYMDA

Under Decree No. 7, made under article 59(1)(ζ) of the Cypriot Basic Requirements laws and published in the Third Annex, Part II of the Official Gazette of the Republic of Cyprus No. 4462 o…

Cyprus issues no national pre-market approval; the route to the CE marking is the Union conformity assessment

Cyprus issues no national pre market approval for a medical device. The only procedure CYMDA describes for a manufacturer to affix the CE marking is the Union conformity assessment procedur…

CE marking under the Union regulations is the domestic route; Cyprus adds no requirement beyond Union and national law

statement: A CE mark under Regulation (EU) 2017/745 (or 2017/746 for in vitro diagnostic medical devices) is the domestic route into Cyprus and is valid throughout the EU/EEA; CYMDA states…

No Cypriot market-access route on the basis of a US FDA, Japan PMDA, Korea MFDS or China NMPA approval

statement: Cyprus, as an EU Member State, operates no abridged, fast track or recognition pathway for a foreign device approval. A device holding only a US FDA, Japan PMDA, Korea MFDS or Ch…

A manufacturer outside the Union must designate a sole authorised representative

A manufacturer of a device that is not established in an EU Member State may place the device on the Cypriot market only if it designates a sole authorised representative in the Union. Cypr…

CYMDA directs importers to MDR Article 13 and distributors to Article 14, plus EUDAMED, traceability and class III implantable duties

CYMDA states that the general obligations of importers are set out in Article 13 and those of distributors in Article 14 of Regulations (EU) 2017/745 / 2017/746 respectively. In addition to…

A distributor must verify compliance, importer details, CE marking and storage conditions before making a device available

Before making a device available on the Cypriot market, a distributor must verify that the device complies with the MDR/IVDR, check that an imported device carries the importer's details as…

Imported devices must carry the importer's name, trade mark, registered place of business and address

A device imported into Cyprus and placed on the market for the first time is compliant as regards labelling only if, in addition to the manufacturer's marking under MDR Annex I point 23.1 /…

A clinical investigation application must be accompanied by the Annex XV Chapter II documents

For the assessment and approval of a clinical investigation of a medical device, a fully completed application must be submitted to CYMDA, accompanied by all the necessary documents set out…

The Cypriot notification is a completed Excel file listing the devices, sent by e-mail to CYMDA

The Cypriot notification is documentary and light: an operator placing medical devices on the Cypriot market notifies CYMDA by sending the completed Excel notification file to cymda@mphs.mo…

CYMDA publishes its service and form list on a single portal page

CYMDA publishes the forms and services of the competent authority on its portal page under the heading «Υπηρεσίες & Έντυπα» (Services & Forms). The list covers the user report form for a vi…

CYMDA issues free-sale certificates for export to manufacturers or authorised representatives established in Cyprus

For export purposes, and on request from a manufacturer or authorised representative established in the Republic of Cyprus, the Cypriot competent authority issues a free sale certificate st…

Decree No. 6 requires the safe-use information in English and/or Greek, and in Greek for lay use

Under Decree No. 6, made under article 59(1)(ζ) of the Cypriot Basic Requirements laws and published in the Official Gazette of the Republic of Cyprus No. 4462 of 5 January 2012, the inform…

CYMDA restated the language requirement on 24 March 2026 and warned of administrative measures and fines

In a notice of 24 March 2026 CYMDA restated the language requirement for medical devices and in vitro diagnostic products: under Decree No. 6, made under article 59(1)(ζ) of the Basic Requi…

CYMDA inspects manufacturers, importers and distributors and their products

CYMDA's role is to monitor the market, protect consumers and safeguard public health, and it does so by inspecting manufacturers, importers and distributors, checking their products and tak…

Medical electrical equipment outside the Low Voltage Directive

Electrical safety

EMC Directive switched off by the more specific MDR essential requirements

EMC

Radio Communications (Radio Equipment) Regulations Κ.Δ.Π. 310/2016, as amended

Wireless / radio

No source-verified answer is published for this dimension yet.

Class I · Self-declaration (no notified body)

0 days

A notified-body certificate is valid for the period it indicates, not exceeding five years, and is renewable

Cyprus issues no national approval with a validity period. The certificate that governs a device's conformity — issued by a notified body under Regulation (EU) 2017/745 — is valid for the p…

MDR transitional periods run to 31 December 2027 / 31 December 2028 for Directive certificate holders

The extended MDR transitional periods run only for devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC, or whose pre 26 May 2021 declaration of conform…

Relabelling or repackaging by a distributor or importer requires 28 days' prior notice to the manufacturer and the competent authority

A distributor or importer that carries out the relabelling or repackaging activities described in Article 16(2) MDR must inform the manufacturer and the competent authority of the Member St…

A substantial modification of a clinical investigation must be notified to CYMDA on the relevant form

A sponsor that has made a substantial modification to a clinical investigation of a medical device must inform CYMDA by sending the relevant form (in Greek or English) to cymda@mphs.moh.gov…

Four EUDAMED modules have been mandatory since 28 May 2026

Following Commission Decision (EU) 2025/2371, the use of the first four functional modules of the European Database on Medical Devices (EUDAMED) has been mandatory since 28 May 2026 in the…

Importers must register in EUDAMED and product traceability is required

CYMDA lists the importer registration duty in EUDAMED (Article 31(1) MDR / Article 28(1) IVDR) and the product traceability obligation (Article 25 MDR / Article 22 IVDR) among the duties th…

A clinical investigation or performance study requires a licence from CYMDA

A clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device conducted in Cyprus requires a licence from CYMDA, provided that the Cyprus Nati…

Device clinical trials are governed by Articles 61 to 80 of Regulation (EU) 2017/745

For clinical trials of medical devices in Cyprus, the provisions of Articles 61 to 80 of Regulation (EU) 2017/745 apply.

Special access / derogation from conformity assessment in Cyprus

A device may be placed on the Cypriot market or put into service without the conformity assessment procedures of Article 52 only under an authorisation granted by the competent authority, t…

Manufacturers must actively collect post-market experience and update the technical file

CYMDA requires manufacturers whose products are placed on the Cypriot market to play an active role in systematically and actively collecting information from the experience of use of their…

Manufacturers must report every serious adverse incident to CYMDA on the Manufacturer incident report 2020 form

Manufacturers have the responsibility of informing the competent authority of every serious adverse incident relating to a product bearing their name, by completing and sending CYMDA the ap…

Suppliers must keep complaint records and inform the manufacturer

Suppliers of medical devices and in vitro diagnostic devices are required under Article 13(6) / Article 14(5) of Regulation (EU) 2017/745 and the corresponding provisions of Regulation (EU)…

CYMDA may recall, withdraw or destroy devices and impose fines or other sanctions

CYMDA's market surveillance actions include the recall of non compliant products from consumers, the withdrawal of products from the market, the destruction of dangerous products and the im…

Administrative measures and fines for non-compliant products are imposed under Cypriot Law 225(I)/2022

Where non compliant products are identified, CYMDA may impose administrative measures and/or fines under Cypriot Law 225(I)/2022 on market surveillance.

Advertising and claims for medical devices in Cyprus

Advertising of, and claims for, medical devices in Cyprus are governed directly by Article 7 of Regulation (EU) 2017/745, which prohibits the use of text, names, trademarks, pictures and fi…

Submission channel and appeal route for device decisions in Cyprus

Notification to the Cypriot competent authority is made by e mail: a person placing medical devices on the Cypriot market must notify the Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA) b…