Ministry of Health · structured requirements

🇨🇾 Cyprus IVD regulatory data

Explore the IVD requirements currently available for Cyprus, organized by topic and linked to official sources.

34 facts19 dimensions17 official sourceslatest verification 2026-09-18

Changes after registration

Common questions about changing a registered IVD in Cyprus. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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

validity.ce-certificate-maximum-five-years

Fact-level verified

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 period it indicates, which may not exceed five years, and on application by the manufacturer its validity may be extended for further periods each not exceeding five years, based on a re-assessment under the applicable conformity assessment procedure. The parallel rule for in vitro diagnostic medical devices is Article 51(2) of Regulation (EU) 2017/746.

Conditions

The Cypriot notification under Decree No. 7 has no stated expiry and CYMDA's pages set no renewal cycle for it; the notification is a listing, not an approval.
The five-year cap applies to notified-body certificates; a class I device that needs no notified body has no certificate and therefore no renewal date under this rule.

Effective from 2021-05-26

English source (Regulation (EU) 2017/745). The excerpt is the Union rule; the statement that Cyprus issues no national approval with a validity period rests on CYMDA's portal, which publishes no approval or renewal procedure, and on Decree No. 7, which sets no term for the notification.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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

authority.cymda-designates-and-supervises-notified-bodies

Fact-level verified

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) 2017/745 and 2017/746 in respect of those notified bodies.

Conditions

CYMDA states that Cyprus has one notified body (HTCert). The authoritative list of notified bodies designated under the MDR/IVDR is the European Commission's NANDO database; that list is maintained by the Commission, not by CYMDA.

Greek source. Translation of the excerpt: 'The Competent Authority for Medical Devices 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) 2017/745 and 2017/746 in respect of those notified bodies.'

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

authority.cymda-is-the-competent-authority

Fact-level verified

The competent Cypriot government authority for medical devices and in vitro diagnostic medical devices is the Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού — the Cyprus Medical Devices Authority (CYMDA) — a unit of the Department of Medical Services and Public Health Services (Ιατρικές Υπηρεσίες και Υπηρεσίες Δημόσιας Υγείας) of the Ministry of Health, seated at Prodromou 1 & Cheilonos 17, 1449 Agios Andreas, Nicosia, and reachable at cymda@mphs.moh.gov.cy. It is a distinct body from the Ministry of Health's Pharmaceutical Services, which handles medicines. CYMDA describes itself as the competent government authority responsible for ensuring that medical devices comply with Cypriot and European legislation.

Conditions

CYMDA signs its instruments as «Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού» under the heading «ΥΠΟΥΡΓΕΙΟ ΥΓΕΙΑΣ — Ιατρικές Υπηρεσίες και Υπηρεσίες Δημόσιας Υγείας».
CYMDA's portal carries a standing notice that the site is being restructured and that current information is published in its Ανακοινώσεις (announcements) section; several reference pages have not been updated, so the announcements and the decree PDFs are the reliable layer.

Greek source. Translation of the excerpt: 'The Competent Authority for Medical Devices is the competent government authority, which is responsible for ensuring medical devices comply with Cypriot and European legislation.' The address and e-mail address are reproduced in the footer of every CYMDA notice consulted in this round.

CYMDA is the market-surveillance authority under Cypriot law and a member of the European market-surveillance group

authority.cymda-market-surveillance-mandate

Fact-level verified

CYMDA is the regulatory authority for market surveillance of medical devices under Cypriot legislation, charged with inspecting manufacturers, importers and distributors and their products and taking the appropriate action where non-compliant products are found. In that role it is a member of the European market-surveillance group, through which national competent authorities notify each other of actions taken on non-compliant products, and it exchanges information and data through the vigilance system.

Conditions

The same page states that national competent authorities investigate consumer complaints about the safety of and problems with products.

Greek source. Translation of the excerpt: 'The Competent Authority for Medical Devices is the regulatory authority, under the legislation, for market surveillance in relation to medical devices, charged with inspecting manufacturers, importers and distributors and also their products, taking the appropriate action when non-compliant products are found. In this context, it is a member of the European Market Surveillance Group through which the national competent authorities inform one another when actions are taken on non-compliant products.'

Classification rules

What local class follows from which rules and decisive product facts?

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Four medical device classes (I, IIa, IIb, III) and four IVD classes (A, B, C, D)

classification.four-device-classes-and-four-ivd-classes

Fact-level verified

Cyprus applies the Union classification: medical devices fall into four classes — I, IIa, IIb and III — and in vitro diagnostic medical devices also fall into four classes — A, B, C and D. Specimen receptacles are also treated as in vitro diagnostic medical devices. CYMDA writes the device classes with Roman numerals (Ι, ΙΙα, ΙΙβ, ΙΙΙ) and the IVD classes with Greek letters (Α, Β, Γ, Δ).

Conditions

The Cypriot page states the classes but does not reproduce the MDR Annex VIII classification rules that assign a class to a given device; those rules are in Regulation (EU) 2017/745 Annex VIII.
The page separately reproduces the Article 2(1) MDR and Article 2(2) IVDR definitions, so a borderline product is classified under the Union rules rather than under any Cypriot rule.

Greek source. Translation of the excerpt: 'Specimen receptacles are also considered in vitro diagnostic medical devices; Medical devices are divided into 4 classes, I, IIa, IIb and III. Medical devices used in in vitro diagnosis are also divided into 4 classes, A, B, C and D.' The exact characters were confirmed against the page's rendered HTML, which reads «τις Ι, ΙΙα, ΙΙβ και ΙΙΙ» and «τις Α, Β, Γ και Δ».

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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A clinical investigation or performance study requires a licence from CYMDA

clinical.cymda-licence-required

Fact-level verified

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 National Bioethics Committee has not issued a negative opinion. Clinical investigations are designed, authorised, conducted, recorded and reported under Article 62 and Articles 63 to 80 of Regulation (EU) 2017/745 and the acts adopted under its Article 81, and under Annex XV; performance studies are conducted under Articles 56 to 57 and 59 to 77 of Regulation (EU) 2017/746, the acts adopted under its Article 107, and Annexes XII and XIV.

Conditions

The licence and the bioethics opinion are cumulative: CYMDA grants the licence on the footing that the National Bioethics Committee has not issued a negative opinion.
The Cypriot page states the legal basis for clinical investigations as Article 62 and Articles 63 to 80 MDR, while the clinical investigation application page states Articles 61 to 80 MDR; the two differ at the lower bound and both are reproduced here as published.

Greek source. Translation of the excerpt: 'It is noted that the clinical investigation/performance study is subject to the granting of a licence by the Competent Authority for Medical Devices provided that the Cyprus National Bioethics Committee has not issued a negative opinion.'

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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

scope.union-definitions-and-annex-xvi-products

Fact-level verified

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 medical device definition of Article 2(2) of Regulation (EU) 2017/746, and records that the MDR also applies, from the date of application of the common specifications adopted under Article 9, to the product groups without an intended medical purpose listed in Annex XVI, taking account of the latest technological developments and in particular the existing harmonised standards for analogous medical-use products based on similar technology.

Conditions

The Cypriot page reproduces the Union definitions with their article anchors but does not restate the full Annex XVI list; the list itself is in Regulation (EU) 2017/745 Annex XVI.

Greek source. Translation of the excerpt: 'Regulation (EU) 2017/745 on medical devices also applies, from the date of application of the common specifications laid down under Article 9, to the product groups without an intended medical purpose referred to in Annex XVI, taking into account the latest developments in technology and in particular the existing harmonised standards for analogous medical-use products based on similar technology.'

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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

operators.importer-and-distributor-general-obligations

Fact-level verified

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 those general obligations it lists: the duty of importers to register in EUDAMED (Article 31(1) MDR / Article 28(1) IVDR); the obligations of an importer that also acts as a manufacturer (Article 16 MDR and IVDR); product traceability (Article 25 MDR / Article 22 IVDR); and the obligations of economic operators involved with class III implantable devices (Article 27(8) MDR).

Conditions

CYMDA also refers distributors and importers to MDCG guidance document 2021-27 on the obligations of distributors and importers, which it describes as providing guidance with examples.
The same notice states that movement of devices within the European market — the EU, the EEA and Turkey — is not an import within the meaning of the MDR/IVDR but a distribution activity; import means entry from a third country, and Switzerland is treated as a third country for this purpose.
The obligations themselves are Union obligations, cited here as CYMDA cites them; the Cypriot element is CYMDA's identification of them as the duties it enforces.

Effective from 2025-11-06

MDR consolidated text, 19 July 2026

UDI retention for class III implantable devices is MDR Article 27(8), independently checked against the consolidated Regulation; the former Article 28(8) citation was incorrect.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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

import.distributor-verification-duty

Fact-level verified

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 required, check that the device bears the appropriate marking under the MDR/IVDR, and ensure that while the device is under its responsibility the storage or transport conditions meet the terms set by the manufacturer — a requirement CYMDA says concerns all the economic operators involved.

Conditions

The duty applies to every distributor, including a distributor of an imported device, and is stated as a condition of making the device available on the market.
CYMDA refers distributors to MDCG guidance 2021-27 for the detail of the distributor and importer obligations.

Effective from 2025-11-06

Greek source, notice of 6 November 2025. Translation of the excerpt: 'Distributors, before making a product — and consequently also an imported product — available on the market, must verify its compliance with the MDR/IVDR Regulations and check that the importer's details are written on the imported product in accordance with the above requirements.'

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

import.importer-details-must-appear-on-the-device

Fact-level verified

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 / IVDR Annex I point 20.2, the importer's name, registered trade name or registered trade mark, registered place of business and address appear on the device, on its packaging or in a document accompanying it. Any additional labelling must not cover any of the information provided by the manufacturer.

Conditions

CYMDA states that on its physical inspections the absence of the importer's details, where required, together with incomplete manufacturer labelling and the absence of instructions for use in Greek where required for lay use, makes the device non-compliant with the MDR/IVDR and makes its import and/or movement an infringement of Article 5(1) that may lead to fines.
Import means entry from outside the European market; movement within the EU, the EEA and Turkey is distribution, and Switzerland is treated as a third country for this purpose (source res-cy-importer-notice-2025).

Effective from 2025-11-06

Greek source, notice of 6 November 2025. Translation of the excerpt: 'Medical devices that are imported and placed on the market for the first time are compliant, as regards labelling, with the MDR/IVDR Regulations, provided that in addition to the marking affixed by the manufacturer (Annex I paragraph 23.1 MDR / Annex I paragraph 20.2 IVDR), the following details of the importer are written on the products or their packaging or in an accompanying document: Name, registered trade name or registered trade mark, Registered place of business and Address.'

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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

label.decree-no-6-english-and-greek-requirement

Fact-level verified

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 information required for the safe and proper use of the product that accompanies each product must be provided in the English and/or Greek language. For products intended for use by non-healthcare professionals, that information must necessarily also be provided in Greek.

Conditions

The decree was made by the Director of Medical Services and Public Health Services on 22 December 2011 and published in Official Gazette No. 4462 of 5 January 2012.
The gazette PDF is a two-page extract: page 1 carries an unrelated decree (Decree No. 1) and page 2 carries Decree No. 6; the citation is to page 2.
English alone is sufficient for a device intended for healthcare professionals; Greek is compulsory in addition only for a device intended for use by non-healthcare professionals.

Effective from 2012-01-05

Greek source, scanned gazette extract read as an image. Translation of the excerpt: 'The information required for the safe and proper use of the product, and which accompanies each product, must be provided in the English and/or Greek language. For products intended for use by non-healthcare professionals this information must necessarily also be provided in Greek.'

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

label.language-notice-march-2026-restates-and-enforces

Fact-level verified

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 Requirements laws 2002 to 2011, the information required for safe and proper use must be provided in English and/or Greek; for products intended for use by non-healthcare professionals it must necessarily also be provided in Greek; and instructions for use must meet the relevant requirements of Regulations (EU) 2017/745 and 2017/746. Importers, distributors, pharmacies, retail points of sale and companies making online sales are told that placing non-compliant products on the market is prohibited, and that where non-compliant products are identified CYMDA may impose administrative measures and/or fines under Law 225(I)/2022 on market surveillance.

Conditions

The notice is an information notice and does not replace the legislation it restates.
The notice cites Decree No. 6 but its stated legal basis is article 59(1)(ζ) of the Basic Requirements laws 2002 to 2011 — a slightly later consolidation date than the 2002 to 2013 list on CYMDA's legislation page.

Effective from 2026-03-24

Greek source, notice of 24 March 2026. Translation of points 1–3: '1. According to Decree No. 6, by virtue of article 59(1)(ζ) of the Basic Requirements which Specified Categories of Products must satisfy Laws of 2002 to 2011, the information required for the safe and proper use of the products must be provided in the English and/or Greek language. 2. For products intended for use by non-healthcare professionals, this information must necessarily also be provided in Greek. 3. The instructions for use must meet the relevant requirements of Regulations (EU) 2017/745 and 2017/746.'

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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

legal-basis.national-implementing-instruments

Fact-level verified

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 Απαιτήσεων που πρέπει να πληρούν Καθορισμένες Κατηγορίες Προϊόντων Νόμοι του 2002 έως 2013), together with the Basic Requirements (Medical Devices) Regulations 2003 to 2013, the Basic Requirements (Active Implantable Medical Devices) Regulations 2003 to 2009, and the Basic Requirements (In Vitro Diagnostic Medical Devices) Regulations 2003. Decree No. 6 (language) and Decree No. 7 (notification) were made under article 59(1)(ζ) of those laws.

Conditions

The page is stale and has not been updated for the MDR/IVDR: it still describes the three repealed Directives as the current Union instruments and gives May 2020 / May 2022 as the implementation deadlines.
Market-surveillance measures and fines are imposed under Cypriot Law 225(I)/2022 on market surveillance (source res-cy-language-notice-2026); that law is not listed on this page.

Greek source. The excerpt is the list as rendered on the page; the items are separate list entries and are reproduced here verbatim.

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

legal-basis.union-regulations-apply-directly

Fact-level verified

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 competent authority for the safety and compliance of medical devices and in vitro diagnostic medical devices placed on the Cypriot market and for the application of Regulations (EU) 2017/745 and 2017/746 and the relevant national legislation.

Conditions

The MDR has applied since 26 May 2021 and the IVDR since 26 May 2022; neither was transposed into Cypriot law, because both are directly applicable regulations.
CYMDA's legislation page has not been updated: it still presents the repealed Directives 90/385/EEC, 93/42/EEC and 98/79/EC as the instruments currently regulating devices in the European Union and gives May 2020 and May 2022 as the MDR/IVDR implementation deadlines, so it must not be relied on for the current legal basis.

Effective from 2026-03-24

Greek source, notice of 24 March 2026. Translation of the excerpt: 'The Competent Authority for Medical Devices, as the competent authority for supervising the safety and compliance of medical devices and in vitro diagnostic products placed on the Cypriot market, and for the application of Regulations (EU) 2017/745 and 2017/746 and the relevant national legislation, points out the following:'

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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

pms.manufacturer-active-post-market-data-collection

Fact-level verified

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 devices after they are placed on the market, in order to update their technical file and to cooperate with the competent authority.

Conditions

The Cypriot page states the duty but does not set a reporting cycle; the underlying obligations, including the post-market surveillance plan and the periodic safety update report, are in MDR Chapter VII and Annex III.
A separate page of the same section refers readers to Commission guidance 2.12 Post-Market Surveillance for the forms and explanatory text of the vigilance system.

Greek source. Translation of the excerpt: 'Manufacturers whose products are placed on the Cypriot market should play an active role by systematically and actively collecting information from the experience of use of their technological products after they are placed on the market, in order to update their technical file and to cooperate with the competent authority.'

Official forms & portals

Which current form, portal, account, and submission package must be used?

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

forms.cymda-services-and-forms-list

Fact-level verified

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 vigilance incident (adverse incident) with a medical device, the form for complaining about a breach of the medical device legislation, the notification of medical devices placed on the Cypriot market, the start of a clinical investigation of a medical device, and the substantial modification of a clinical investigation of a medical device. The portal page also points to the announcements section and to the authority's information material as the current source of information.

Conditions

The portal carries a standing notice that the website is being restructured and updated, and asks readers to follow the announcements section for the latest developments; the forms list may therefore be incomplete relative to the announcements.
The clinical investigation forms are published on separate pages in Greek and English; the notification and vigilance forms are reached from the same list.

Greek source. Translation of the opening sentence of the relevant passage: 'In addition, below you will find links to the main services of the Competent Authority, which concern the notification of economic operators, clinical investigations and performance studies, the submission of complaints and the reporting of incidents.' The excerpt is the rendered form list that follows it.

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

forms.free-sale-certificate-for-export

Fact-level verified

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 stating that the manufacturer or authorised representative, as the case may be, has its registered place of business in Cyprus and that the device bearing the CE marking under the Regulation may be placed on the Union market. The certificate is an outbound export document issued to a Cyprus-established applicant; it is not a market-access requirement for importing a device into Cyprus.

Conditions

The applicant must be established in the Republic of Cyprus; a foreign manufacturer without a Cypriot establishment cannot apply directly.
The certificate presupposes that the device already bears the CE marking, so it adds nothing to the CE route into the Cypriot market.

Greek source. Translation of the excerpt: 'For the purposes of export and following a request by the manufacturer/authorised representative established in the Republic of Cyprus, the Cypriot Competent Authority issues a free-sale certificate stating that the manufacturer/authorised representative, as the case may be, has its registered place of business in the territory of the Republic of Cyprus and that the said technological product bearing the CE marking in accordance with the present regulation may be made available on the market of the Union.'

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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CYMDA inspects manufacturers, importers and distributors and their products

qms.cymda-inspects-manufacturers-importers-distributors

Fact-level verified

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 taking the appropriate action when non-compliant products are found. The inspection is carried out by the competent authority itself; Cyprus has no separate device inspectorate.

Conditions

The Cypriot page describes the inspection role but does not state an inspection frequency, a fee or a notice period.
The actions that follow an inspection are recall of non-compliant products from consumers, withdrawal from the market, destruction of dangerous products and the imposition of fines or other sanctions (source res-cy-market-surveillance).

Greek source. Translation of the excerpt: 'The role of the Competent Authority is to monitor the market and to ensure the protection of consumers and to safeguard public health. This is achieved by inspecting manufacturers, importers and distributors, checking their products and taking the appropriate action when non-compliant products are found.'

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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

recall.cymda-recall-withdrawal-destruction-and-fines

Fact-level verified

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 imposition of fines or other sanctions, and it exchanges information and data through the vigilance system so that other countries can take comparable safety measures.

Conditions

The Cypriot page describes the powers but does not set out a recall procedure, a recall classification or a reporting deadline for corrective actions; those follow the MDR field-safety-corrective-action rules (Article 87 and Chapter VII).
National competent authorities investigate consumer complaints about the safety of and problems with products (source res-cy-cymda-role).

Greek source. Translation of the excerpt: 'Such actions include recall of non-compliant products from consumers, withdrawal of products from the market, destruction of dangerous products and the imposition of fines or other sanctions. In addition, information and data are exchanged through the vigilance system.'

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

recall.law-225-2022-administrative-measures-and-fines

Fact-level verified

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

Conditions

Law 225(I)/2022 is the Cypriot market-surveillance law named in CYMDA's own notices; it is not listed on CYMDA's (stale) legislation page.
The notices state the penalty power but do not set the amount of any fine; no Cypriot device fee or penalty schedule was located.

Effective from 2026-03-24

Greek source, notice of 24 March 2026. Translation of the excerpt: 'In the event that non-compliant products are identified, the Competent Authority may impose administrative measures and/or fines, in accordance with Law 225(I)/2022 on market surveillance.'

Missing importer details or a missing Greek IFU for lay use makes a device non-compliant on inspection

recall.missing-importer-details-or-greek-ifu-non-compliant

Fact-level verified

CYMDA states that during its physical inspections the absence of the importer's details (where required), incomplete labelling by the manufacturer, and the absence of instructions for use in Greek (where required and where the product is intended for non-healthcare professionals) make the medical device non-compliant with the MDR/IVDR; the notice continues that its import and/or movement is an infringement of Article 5(1) and may lead to the imposition of fines.

Conditions

This is stated as the position CYMDA takes on physical inspections, i.e. as an enforcement practice rather than as a separate offence created by Cypriot law; the penalty power is Law 225(I)/2022 (source res-cy-language-notice-2026).
The passage is split by a page break in the source; the excerpt quotes the part on page 1 and the continuation (infringement of Article 5(1), fines) is on page 2.

Effective from 2025-11-06

Greek source, notice of 6 November 2025. Translation of the excerpt: 'It is noted that during the physical inspections of the Competent Authority, the absence of the importer's details (where required), incomplete labelling by the manufacturer and the absence of instructions for use in Greek (where required and where the product is intended for non-healthcare professionals), makes the medical device non-compliant with the MDR/IVDR ...'. The sentence continues on page 2 with '... and its import and/or movement constitutes an infringement of Article 5(1) and may lead to the imposition of fines.'

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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

registration.no-national-approval-before-ce-marking

Fact-level verified

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 procedure: the manufacturer must document that the device bearing its name meets the essential requirements of Annex I of the relevant legislation, following the conformity assessment procedure that the legislation lays down for the type of device, and where that procedure requires a notified body the manufacturer may approach a body of its choice within the body's notified scope. The manufacturer then affixes the CE marking, accompanied by the notified body's four-digit number where a notified body was involved, and draws up a declaration of conformity.

Conditions

The only pre-market interaction with CYMDA for a CE-marked device is the Decree No. 7 notification, which is a listing duty and not an assessment of the device.
CYMDA refers manufacturers to the European Commission's list of notified bodies and to the list of harmonised standards rather than maintaining its own approval list.
The Cypriot page states the CE-marking route but does not reproduce the Annex II technical documentation requirements; those are in Regulation (EU) 2017/745 Annex II.

Greek source. Translation of the excerpt: 'In order to affix the necessary CE marking the manufacturer must document that the medical device bearing its name meets the essential requirements of Annex I of the relevant legislation, following, depending on the type of product, the appropriate Conformity Assessment Procedure laid down in that legislation, as shown in the table below.' The negative half of the claim (that Cyprus issues no national approval) is corroborated by the absence of any such procedure on CYMDA's portal and by the statement that CYMDA has imposed no requirement beyond Union and national law (source res-cy-importer-notice-2025).

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Cyprus approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Cyprus (3 records)

CyprusEU conformity assessment

Prior approval / evidence record

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

reliance.eu-ce-marking-is-the-domestic-route

Fact-level verified

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 that it has so far imposed no additional requirement beyond those provided for by Union and national legislation. What a CE holder still owes Cyprus is local: notify each device to CYMDA under Decree No. 7, ensure the importer is identified on the device, its packaging or an accompanying document, supply the information needed for safe and proper use in English and/or Greek (Greek mandatory for use by non-healthcare professionals), register in EUDAMED, and accept the market-surveillance and penalty powers under Law 225(I)/2022.
Source Approval: EU CE Marking under Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic medical devices
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: No

Conditions

The device notification under Decree No. 7 (Official Gazette No. 4462, 5 January 2012) must be made by each economic operator separately: CYMDA states that the notification of a device by one economic operator is independent of its notification of the same device by another economic operator.
The importer's name, registered trade name or registered trade mark, registered place of business and address must appear on the device, its packaging or an accompanying document, in addition to the manufacturer's marking under MDR Annex I point 23.1 / IVDR Annex I point 20.2, and any additional labelling must not cover information provided by the manufacturer.
Information required for the safe and proper use of the product must be provided in English and/or Greek; for products intended for use by non-healthcare professionals it must necessarily also be provided in Greek (Decree No. 6).
Economic operators (manufacturers, authorised representatives and importers) must register in the EUDAMED Actor module and manufacturers must register their devices in the UDI/Devices module; as at 15 September 2026 the first four EUDAMED modules have been mandatory since 28 May 2026.
A manufacturer without an establishment in a Member State may place the device on the Union market only by designating a sole authorised representative (Regulation (EU) 2017/745 Article 11(1)).
CYMDA states that on physical inspections the absence of the importer's details where required, incomplete manufacturer labelling, and the absence of instructions for use in Greek where required for lay use, make the device non-compliant with the MDR/IVDR and make its import and/or movement an infringement of Article 5(1) that may lead to fines.

Effective from 2025-11-06

Greek source, notice of 6 November 2025. Translation of the excerpt: 'the Competent Authority, responsible for market surveillance and the safety of medical devices in the Republic of Cyprus, and for supervising the application of the relevant Regulations, has so far not imposed any additional requirement beyond those provided for by Union and national legislation.' The excerpt supports the bounded claim that Cyprus itself adds nothing to the Union route; the CE mark's EU/EEA-wide effect rests on Regulation (EU) 2017/745 (source res-cy-mdr-2017-745).

CyprusUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)MDR Annex IX — conformity assessment based on a quality management system and on assessment of technical documentation (§5.1 expert-panel consultations, §5.2(d) medicinal-products authority opinion)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)CYMDA notice of 6 November 2025 on recording the importer's details and other distributor and importer duties — restates Decree No. 7 published in the Third Supplement of the Official Gazette of 5 January 2012 CYMDA announcement of 24 March 2026 on language requirements — Decree No. 6 under article 59(1)(ζ) of the Basic Requirements Laws 2002 to 2011 CYMDA notice of 8 January 2026 — compulsory use of the first four EUDAMED modules (actor registration, UDI/devices registration, notified bodies and certificates) from 28 May 2026 under Commission Decision (EU) 2025/2371 CYMDA — commencement of a clinical investigation or performance study in Cyprus: MDR Articles 62 and 63 to 80 with Annex XV; IVDR Articles 56 to 57 and 59 to 77 with Annexes XII and XIV; CYMDA authorisation granted where the Cyprus National Bioethics Committee has not issued a negative opinion

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

CyprusUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

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

reliance.no-route-for-non-ce-approvals

Fact-level verified

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 China NMPA approval cannot be placed on the Cypriot market: Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are directly applicable and permit placing on the market only of a device that complies with them, and CYMDA's own description of how a manufacturer affixes the CE marking describes only the Union conformity assessment procedure, with no national pre-market approval step and no reference to any third-country approval.
Source Approval: none
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Premarket Review
Local Application Required: No
Target Decision Retained: Yes

Conditions

Regulation (EU) 2017/745 has applied since 26 May 2021 and Regulation (EU) 2017/746 since 26 May 2022; both are binding in their entirety and directly applicable in Cyprus, so there is no Cypriot transposition act and no Cypriot approval decision for a CE-marked device.
The only Union exception is the public-health derogation (Article 59 MDR / Article 54 IVDR), by which a Member State may authorise a device that has not undergone the applicable conformity assessment; that authorisation rests on a public-health or patient-safety ground, is not recognition of a third-country approval, and does not extend outside the authorising Member State.
The extended transitional periods of Regulation (EU) 2023/607 benefit only devices covered by a Directive 90/385/EEC or 93/42/EEC certificate, or whose pre-26 May 2021 declaration of conformity did not require a notified body; an FDA, PMDA, MFDS or NMPA approval confers nothing under those provisions.
Cyprus has no separate national device-approval instrument: the only national acts located are Decree No. 6 (language) and Decree No. 7 (notification), both made under article 59(1)(ζ) of the Basic Requirements laws, plus market-surveillance penalties under Law 225(I)/2022.

Effective from 2021-05-26

English source (Regulation (EU) 2017/745). The excerpt is the Union rule that governs placing on the Cypriot market. The Cypriot side of the same answer is CYMDA's conformity-assessment page (source res-cy-conformity-assessment), which describes only the Annex I essential-requirements plus notified-body route, and CYMDA's statement that it has imposed no additional requirement beyond Union and national law (source res-cy-importer-notice-2025). No Cypriot or Union instrument consulted names an FDA, PMDA, MFDS or NMPA approval as a basis for placing a device on the Cypriot market.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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The Notifying Authority decides on a conformity assessment body's application within 30 days and notifies it within 10 days

clock.conformity-assessment-body-approval-30-days

Fact-level verified

A conformity assessment body established in Cyprus applies to the Notifying Authority, composed of a representative of the Coordinating Authority and of the competent authority for the product, on the form published by the Minister. The Notifying Authority examines the application and decides within 30 days whether to approve or reject it; the decision is communicated to the applicant within 10 days of being taken and, if approved, notified to the European Commission within 30 days.

Conditions

General national rule for notified-body approval under the Market Surveillance Law; for medical devices the designation assessment also follows the joint-assessment procedure and periods of MDR Articles 38–39 / IVDR Articles 34–35.
Applications are accepted only from legal persons established in the Republic (Article 11(3)).

Effective from 2022-12-22

Greek source. Translation: '(4) The Notifying Authority examines the application of an interested conformity assessment body and decides within thirty (30) days whether to approve or reject it. (5)(a) The decision provided for in subsection (4) is communicated to the interested conformity assessment body within ten (10) days of its adoption. (b) Where the application is approved, the Notifying Authority notifies its decision to the Commission within thirty (30) days.' Revocation of an approval may be challenged by hierarchical appeal to the Minister within 30 days, decided within 60 days (Article 15).

Hierarchical appeal against administrative fines or cost recovery: 30 days to lodge, Minister decides within 90 days, court within 75 days

clock.hierarchical-appeal-against-fines-30-days-decision-90-days

Fact-level verified

Any decision imposing an administrative fine and/or recovering costs under the Law may be challenged by hierarchical appeal to the Minister within 30 days of the interested person becoming aware of it. The Minister examines the appeal immediately, may hear the appellant, and notifies the decision, which may confirm, annul or amend the fine, within 90 days of the appeal being lodged; a person dissatisfied with that decision may apply to the Administrative Court within 75 days. Unpaid fines are recovered as a civil debt to the Republic.

Conditions

Administrative fines under Article 30 of the Law are the sanction CYMDA's notices refer to for non-compliant devices; criminal offences under Article 33 are separate.

Effective from 2022-12-22

Greek source. Translation: '(1) Any decision imposing an administrative fine and/or recovering costs issued under this Law is subject to hierarchical appeal before the Minister within thirty (30) days of the date on which the interested person becomes aware of the decision. (3)(b) The Minister decides on every appeal as quickly as possible and notifies the decision to the appellant within ninety (90) days of the date the appeal was lodged. (5) A person not satisfied with the decision issued by the Minister under subsection (4) may apply, within seventy-five (75) days, to the Administrative Court.'

Hierarchical appeal against market-surveillance measures: 15 days to lodge, Minister decides within 60 days, court within 75 days

clock.hierarchical-appeal-against-measures-15-days-decision-60-days

Fact-level verified

An interested person may lodge a hierarchical appeal to the Minister against a competent-authority decision imposing measures under Articles 24 and 25 within 15 days of notification of the measure. The Minister examines the appeal immediately, may hear the appellant, and notifies the decision, which may confirm, annul or amend the contested decision, within 60 days of the appeal being lodged. A person dissatisfied with the Minister's decision may apply to the Administrative Court within 75 days.

Conditions

The 'Minister' under the Law is the Minister of Energy, Commerce and Industry (Article 2), even where the competent authority is CYMDA in the Ministry of Health.
The Minister may require the operator to produce evidence within a set period and treat factual claims as inaccurate if it is not produced in time (Article 27(2)).

Effective from 2022-12-22

Greek source. Translation: '(1) An interested person may lodge a hierarchical appeal against a decision of the competent authority to take measures under Articles 24 and 25 before the Minister within fifteen (15) days of the date the measure is notified to the interested person. (3)(b) The Minister decides on every appeal as quickly as possible and notifies the decision to the appellant within sixty (60) days of the date the appeal was lodged. (5) A person not satisfied with the decision issued by the Minister under subsection (4) may apply within seventy-five (75) days to the Administrative Court.' The existing Article 146 constitutional-recourse fact records the general 75-day court route.

Restrictive market-surveillance measures are notified within 15 days and preceded by a hearing period of at least 10 working days

clock.market-surveillance-measures-notified-15-days-hearing-10-working-days

Fact-level verified

Measures taken by the competent authority under Part IV of the Law that restrict the making available or putting into service of products must be adequately reasoned and are notified to the economic operator within 15 days of the decision, with a statement of the remedies and their deadlines. Before a measure is applied the interested party may submit its views in writing or orally within the period set in the notice, which may not be shorter than 10 working days, except where the measure is taken urgently for public health, safety or other public-interest reasons, in which case the operator is heard as soon as possible and the measure is reviewed immediately.

Conditions

Applies to CYMDA acting as competent authority for medical devices and IVDs under the Annex to the Law; the urgent-measure exception in Article 25 covers products presenting a serious risk.

Effective from 2022-12-22

Greek source. Translation: '(2) The measures provided for in subsection (1) are notified to the economic operator at the latest within fifteen (15) days of the decision, with reference to the judicial or other remedies available to challenge the competent authority's decision and the deadlines within which they must be exercised. (3) The interested party is entitled to submit its opinion in writing or orally before the competent authority prior to the application of the measure and within the period set in the notice, which may not be shorter than ten (10) working days, except in the case of urgent adoption of the measure for reasons of public health or safety and/or any other public-interest reasons as provided in the relevant legislation and/or Article 25 of this Law.'

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

Conformity may be presumed from correspondence with the relevant harmonised European standards

standards.harmonised-standards-presumption-of-conformity

Fact-level verified

CYMDA states that the conformity of a product with the relevant legislation may be presumed to a degree where the product corresponds to the relevant harmonised European standards, giving EN ISO 13485:2016 as an example, and it links to the list of harmonised standards.

Conditions

CYMDA links to the European Commission's list of harmonised standards rather than publishing its own list.
The Cypriot page expresses the presumption as partial ('to a degree'), and does not restate the MDR Article 8 presumption-of-conformity rule.

Greek source. Translation of the excerpt: 'The conformity of a product with the relevant legislation may be presumed to a degree by the correspondence of the product with the relevant harmonised European standards (e.g. EN ISO 13485:2016).'

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Four EUDAMED modules have been mandatory since 28 May 2026

udi.four-eudamed-modules-mandatory-from-28-may-2026

Fact-level verified

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 application of Regulations (EU) 2017/745 and 2017/746: actor registration (Articles 30 MDR / 27 IVDR), the UDI database and electronic device registration system (Articles 28–29 MDR / 25–26 IVDR), notified bodies and certificates (Articles 57 MDR / 52 IVDR) and market surveillance (Article 100 MDR / 95 IVDR). Economic operators — manufacturers, authorised representatives and importers — must register in the actor module, manufacturers must register their devices in the UDI database and the device registration module, and notified bodies must attach their issued certificates in the notified bodies and certificates module.

Conditions

State as of 2026-09-15: the four modules have been mandatory for some three and a half months; the vigilance and clinical investigation modules had not been declared functional.
Manufacturers must first register as economic operators and obtain an SRN before registering devices.
The Commission notice of 27 November 2025 started the six-month clock, so the modules became mandatory on 28 May 2026.

Effective from 2026-05-28

Greek source, CYMDA notice of 8 January 2026. Translation of the excerpt: 'From the date of 28 May 2026, the following electronic modules of EUDAMED, which have been confirmed as fully functional, must be used compulsorily: • Registration of economic operators (Actor registration, articles 30 MDR/27 IVDR). • UDI database and electronic system for registration of medical devices (UDI/Devices registration, articles 28-29 MDR/25-26 IVDR). • Notified Bodies and certificates (Notified Bodies & Certificates, articles 57 MDR/52 IVDR). • Market surveillance (Market Surveillance, article 100 MDR/95 IVDR).'

Importers must register in EUDAMED and product traceability is required

udi.importer-registration-and-traceability

Fact-level verified

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 that apply to operators importing and distributing medical devices in Cyprus, alongside the obligations of an importer acting as manufacturer (Article 16 MDR/IVDR) and the obligations of economic operators involved with class III implantable devices (Article 28(8) MDR).

Conditions

The duties are Union duties that CYMDA identifies as those it enforces on the Cypriot market; the Cypriot element is CYMDA's own listing of them.
From 28 May 2026 the EUDAMED actor module is mandatory, so importer registration is no longer optional (source res-cy-eudamed-notice-2026).

Effective from 2025-11-06

Greek source, notice of 6 November 2025. Translation of the excerpt: '- Obligation for Importers to register in EUDAMED (Article 31(1) MDR/28(1) IVDR) - Obligations of an importer operating as a manufacturer (Article 16 MDR and 16 IVDR), - Obligation for product traceability (Article 25 MDR and 22 IVDR), - Obligations for economic operators involved with class III implantable products (Article 28(8) MDR),'

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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

vigilance.manufacturer-serious-incident-reporting

Fact-level verified

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 appropriate form (Manufacturer incident report 2020). CYMDA directs readers to Chapter VII of Regulations (EU) 2017/745 and 2017/746 for the reporting procedure and for post-market surveillance.

Conditions

The Cypriot page names the reporting form but does not state the reporting deadlines; those are in MDR Article 87: not later than 15 days after becoming aware of a serious incident (Article 87(3)), not later than 2 days for a serious public-health threat (Article 87(4)), and not later than 10 days in the event of death or an unanticipated serious deterioration in a person's state of health (Article 87(5)).
The same source states that national competent authorities exchange information and data through the vigilance system so that other countries can take comparable safety measures.

Greek source. Translation of the excerpt: '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 us the appropriate form (Manufacturer incident report 2020).'

Suppliers must keep complaint records and inform the manufacturer

vigilance.supplier-complaint-records

Fact-level verified

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) 2017/746 to keep records of complaints, to inform the manufacturer and to provide any useful information at the manufacturer's request. CYMDA states that managing the incidents, problems and complaints arising from the use of the devices they supply is therefore an obligation of suppliers.

Conditions

The same notice places on healthcare professionals a duty to report to the manufacturer, directly or through the supply chain; the supplier's records are the distribution-side counterpart.
The notice describes an incident, problem or complaint as any occurrence concerning the operation, performance or safety of a product, such as malfunction, inaccuracy of results (particularly with IVDs), premature wear, or any unexpected behaviour that may endanger the health of patients or users.

Effective from 2025-07-30

Greek source, notice of 30 July 2025. The sentence quoted begins on page 1 and continues on page 2, so the excerpt starts mid-sentence at the page break; the passage is verbatim and contiguous in the source. Translation: '... of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) to keep records of complaints, to inform the manufacturer and to provide any useful information at his request. Consequently it is an obligation of suppliers to manage the incidents, problems and complaints arising from the use of the MDs/IVDs they supply.'

Healthcare professionals may report incidents to CYMDA by user report form or Microsoft Forms

vigilance.user-report-channel-to-cymda

Fact-level verified

Healthcare professionals may report incidents, problems or complaints arising from the use of medical devices and in vitro diagnostic devices to CYMDA by two channels: completing the attached Medical Devices Adverse Incident User Report Form and sending it to cymda@mphs.moh.gov.cy, or completing the Microsoft Forms electronic form linked from the notice. CYMDA recommends that users also report every incident, problem, complaint or event relating to a device to the manufacturer, directly or through the supply chain.

Conditions

The user report channel is supplementary to the manufacturer's own reporting duty: CYMDA asks users to notify the manufacturer directly or through the supply chain, and offers the CYMDA channel as an additional route.
The notice asks healthcare professionals to give full product identification when reporting (product name, serial number, UDI, model, lot number, batch number, date of manufacture, expiry date) and recommends retaining the device in question in case the manufacturer asks to examine it.

Effective from 2025-07-30

Greek source, notice of 30 July 2025. Translation of the excerpt: 'The reporting of incidents, complaints and problems to the Competent Authority may be carried out in the following ways: 1. Completion of the attached form (Medical-Devices-Adverce-Incident-User-Report-Form) and sending to the Competent Authority by electronic mail: cymda@mphs.moh.gov.cy 2. Completion of the electronic Microsoft Forms form at the following link: https://forms.cloud.microsoft/e/pG2ZrYFivk'. The misspelling 'Adverce' is as printed in the source.

Related structured datasets

Classification systems · 1 record

Open EU IVDR classes A, B, C and D →

cyprus:ivd

Jurisdiction Id

cyprus

Domains

Name

EU IVDR classes A, B, C and D

Description

National projection of the directly applicable EU IVDR classification. The canonical class axis and rules are maintained in eu:ivd; the Cypriot references describe only administration — the separate CYMDA registration form for in-vitro diagnostic products and the language rule, which the CYMDA applies to in-vitro diagnostic products expressly.

Classes

Id
a
Label
IVD Class A
Normalized Risk Level
low
Id
b
Label
IVD Class B
Normalized Risk Level
medium
Id
c
Label
IVD Class C
Normalized Risk Level
high
Id
d
Label
IVD Class D
Normalized Risk Level
highest

Regulator

CYMDA

Official Domains

gov.cy
eur-lex.europa.eu

Source Status

official-source-verified

Reference Sources

Title
CYMDA — Registration for IVD products
Url
https://www.gov.cy/moh-mphs/documents/registration-for-ivd-products/
Reviewed On
2026-09-16
Supports
In-vitro diagnostic devices have their own national route rather than sharing the medical-device spreadsheet: the CYMDA publishes a separate 'REGISTRATION-FOR-IVD-PRODUCTS' application form alongside the medical-device notification form, both filed under the Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού. No class is assigned in that procedure.
Title
CYMDA announcement of 24 March 2026 — ΑΝΑΚΟΙΝΩΣΗ ΓΙΑ ΓΛΩΣΣΙΚΕΣ ΑΠΑΙΤΗΣΕΙΣ ΙΑΤΡΟΤΕΧΝΟΛΟΓΙΚΩΝ ΚΑΙ IN-VITRO ΔΙΑΓΝΩΣΤΙΚΩΝ ΠΡΟΙΟΝΤΩΝ
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%91%CE%9D%CE%91%CE%9A%CE%9F%CE%99%CE%9D%CE%A9%CE%A3%CE%97-%CE%91%CE%A0%CE%9F-CYMDA-%CE%93%CE%99%CE%91-%CE%93%CE%9B%CE%A9%CE%A3%CE%A3%CE%99%CE%9A%CE%95%CE%A3-%CE%91%CE%A0%CE%91%CE%99%CE%A4%CE%97%CE%A3%CE%95%CE%99%CE%A3.pdf
Reviewed On
2026-09-16
Supports
The CYMDA applies the same operative language rule to in-vitro diagnostic products by name: the announcement is addressed to ιατροτεχνολογικών και in-vitro διαγνωστικών προϊόντων, cites Regulation (EU) 2017/746 alongside 2017/745, and states that the information for safe and proper use must be in English and/or Greek, necessarily also in Greek where the product is intended for non-healthcare professionals.
Title
CYMDA notice of 6 November 2025 — importer details on medical devices and other distributor/importer duties
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%91%CE%9D%CE%91%CE%9A%CE%9F%CE%99%CE%9D%CE%A9%CE%A3%CE%97-%CE%93%CE%99%CE%91-%CE%A4%CE%97%CE%9D-%CE%91%CE%9D%CE%91%CE%93%CE%A1%CE%91%CE%A6%CE%97-%CE%A4%CE%A9%CE%9D-%CE%A3%CE%A4%CE%9F%CE%99%CE%A7%CE%95%CE%99%CE%A9%CE%9D-%CE%A4%CE%9F%CE%A5-%CE%95%CE%99%CE%A3%CE%91%CE%93%CE%A9%CE%93%CE%95%CE%91-6-11-25.pdf
Reviewed On
2026-09-16
Supports
The notice fixes the importer-details duty for in-vitro diagnostic devices by reference to IVDR Annex I paragraph 20.2 in the same terms as MDR Annex I paragraph 23.2 — name, registered trade name or trade mark, registered place of business and address — and states that the absence of the importer details, incomplete manufacturer marking, or the absence of Greek instructions for use where the product is intended for non-healthcare professionals makes the product non-compliant and can lead to fines.

Inherited From Scheme Id

eu:ivd

Source Title

Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Art. 47 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/746/oj

Verified On

2026-09-16

Source Supports

ivd-class-axis
ivd-classification-rules

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Cyprus registration →

Country

Cyprus

Jurisdiction Id

cyprus

Country Code

Flag

🇨🇾

Regulator

Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Medical Services and Public Health Services, Ministry of Health

Regulator Abbrev

Ministry of Health

Region

europe

Tier

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Self-declaration (no notified body)
Official Timeline
Min
0
Max
0
Unit
days
Verification Status
official-verified
Official Source
Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-09-16
Realistic Timeline
Min
6
Max
9
Notes
MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so neither the CYMDA nor a notified body reviews the file and there is no review clock
Elapsed time is EUDAMED actor and device registration, mandatory since 28 May 2026 and carrying no guaranteed processing time, plus the Cypriot notification duty under Decree No. 7, for which the CYMDA publishes no period
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes

Prior Approvals

Authority
FDA 510(k)/PMA
Accepted
No
Benefit
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Key Requirements

EU Authorized Representative (for non-EU manufacturers)
Notification of the medical devices an operator places on or makes available on the Cypriot market to the CYMDA, by sending the CYMDA spreadsheet to cymda@mphs.moh.gov.cy; the duty derives from Decree No. 7 published in Part II of the Third Supplement of the Official Gazette of 5 January 2012 and is restated in the CYMDA notice of 6 November 2025
The notification is per economic operator and not per product: the CYMDA states that one economic operator's notification of a device is independent of another economic operator's notification of the same device
Importer details — name, registered trade name or trade mark, registered place of business and address — on the device, its packaging or an accompanying document, without covering any of the manufacturer's markings (MDR Annex I §23.2 / IVDR Annex I §20.2)
Information for safe and proper use in English and/or Greek, and necessarily also in Greek for products intended for use by non-healthcare professionals (Decree No. 6 under article 59(1)(ζ) of the Basic Requirements Laws 2002 to 2011); the instructions for use must also meet the requirements of Regulations (EU) 2017/745 and 2017/746
Distributors must verify a device's conformity and the presence of the importer details before making it available, and must keep storage and transport conditions within the manufacturer's terms
EUDAMED actor registration (MDR Art. 31(1) / IVDR Art. 28(1)) and device registration in the UDI database (MDR Arts. 28-29 / IVDR Arts. 25-26), compulsory since 28 May 2026 under Commission Decision (EU) 2025/2371
A clinical investigation or performance study requires authorisation from the CYMDA, which is granted where the Cyprus National Bioethics Committee has not issued a negative opinion (MDR Arts. 62 and 63 to 80 with Annex XV; IVDR Arts. 56 to 57 and 59 to 77 with Annexes XII and XIV)
In-vitro diagnostic products are registered with the CYMDA on the separate 'Registration for IVD products' form rather than on the medical-device notification spreadsheet
Non-compliant devices may attract administrative measures and/or fines under Law 225(I)/2022 on market surveillance

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources

Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-09-16
Title
MDR Annex IX — conformity assessment based on a quality management system and on assessment of technical documentation (§5.1 expert-panel consultations, §5.2(d) medicinal-products authority opinion)
Url
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
Accessed Date
2026-09-16
Title
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
Url
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
Effective Date
2027-02-25
Accessed Date
2026-09-16
Title
CYMDA notice of 6 November 2025 on recording the importer's details and other distributor and importer duties — restates Decree No. 7 published in the Third Supplement of the Official Gazette of 5 January 2012
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%91%CE%9D%CE%91%CE%9A%CE%9F%CE%99%CE%9D%CE%A9%CE%A3%CE%97-%CE%93%CE%99%CE%91-%CE%A4%CE%97%CE%9D-%CE%91%CE%9D%CE%91%CE%93%CE%A1%CE%91%CE%A6%CE%97-%CE%A4%CE%A9%CE%9D-%CE%A3%CE%A4%CE%9F%CE%99%CE%A7%CE%95%CE%99%CE%A9%CE%9D-%CE%A4%CE%9F%CE%A5-%CE%95%CE%99%CE%A3%CE%91%CE%93%CE%A9%CE%93%CE%95%CE%91-6-11-25.pdf
Accessed Date
2026-09-16
Title
CYMDA announcement of 24 March 2026 on language requirements — Decree No. 6 under article 59(1)(ζ) of the Basic Requirements Laws 2002 to 2011
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%91%CE%9D%CE%91%CE%9A%CE%9F%CE%99%CE%9D%CE%A9%CE%A3%CE%97-%CE%91%CE%A0%CE%9F-CYMDA-%CE%93%CE%99%CE%91-%CE%93%CE%9B%CE%A9%CE%A3%CE%A3%CE%99%CE%9A%CE%95%CE%A3-%CE%91%CE%A0%CE%91%CE%99%CE%A4%CE%97%CE%A3%CE%95%CE%99%CE%A3.pdf
Accessed Date
2026-09-16
Title
CYMDA notice of 8 January 2026 — compulsory use of the first four EUDAMED modules (actor registration, UDI/devices registration, notified bodies and certificates) from 28 May 2026 under Commission Decision (EU) 2025/2371
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%A5%CF%80%CE%BF%CF%87%CF%81%CE%B5%CF%89%CF%84%CE%B9%CE%BA%CE%AE-%CF%87%CF%81%CE%AE%CF%83%CE%B7-%CF%84%CE%B5%CF%83%CF%83%CE%AC%CF%81%CF%89%CE%BD-%CE%B5%CE%BD%CE%BF%CF%84%CE%AE%CF%84%CF%89%CE%BD-%CF%84%CE%B7%CF%82-EUDAMED.pdf
Accessed Date
2026-09-16
Title
CYMDA — commencement of a clinical investigation or performance study in Cyprus: MDR Articles 62 and 63 to 80 with Annex XV; IVDR Articles 56 to 57 and 59 to 77 with Annexes XII and XIV; CYMDA authorisation granted where the Cyprus National Bioethics Committee has not issued a negative opinion
Url
https://www.gov.cy/moh-mphs/documents/enarxi-klinikis-ereynas-meleti-epidoseon-stin-kypro/
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ministry of Health. Appoint a EU Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Ministry of Health including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Ministry of Health reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Ministry of Health may issue questions.
Duration
0 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Ministry of Health issues Cyprus market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 0 records

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

No maintained record.

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Cyprus certifications →

Slug

cyprus

Market

Cyprus

Confidence

high

Schemes

Id
lvd-medical-exclusion-mdr-electrical-safety
Name
Medical electrical equipment outside the Low Voltage Directive
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Annex II of Directive 2014/35/EU, headed 'Equipment and phenomena outside the scope of this Directive', places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so a medical device attracts no separate Cypriot low-voltage certificate; electrical safety is assessed inside the MDR conformity assessment against MDR Annex I rather than by a low-voltage authority. Low-voltage electrical equipment in Cyprus is the responsibility of the Electrical and Mechanical Services Department (Τμήμα Ηλεκτρομηχανολογικών Υπηρεσιών) of the Ministry of Transport, Communications and Works, which publishes its harmonising legislation; the Cypriot low-voltage instrument itself was not located, so this row is bound to the Directive and to the MDR at candidate grade.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/35/oj
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Source Binding
candidate
Id
emc-directive-disapplied-by-mdr
Name
EMC Directive switched off by the more specific MDR essential requirements
Category
emc
Status
Included In Medical Registration
Object
Finished Device
Note
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices, so electromagnetic compatibility is dossier evidence inside the CE route and not a separate Cypriot conformity step. Cyprus harmonises the Directive through the Basic Requirements (Electromagnetic Compatibility) Regulations Κ.Δ.Π. 181/2017 and Κ.Δ.Π. 589/2020, published on the legislation index of the Electrical and Mechanical Services Department of the Ministry of Transport, Communications and Works; the Directive text that carries the disapplication was not re-read this round, so the row is bound at candidate grade.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/30/oj
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Source Binding
candidate
Id
dec-radio-equipment-regulations
Name
Radio Communications (Radio Equipment) Regulations Κ.Δ.Π. 310/2016, as amended
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Note
Radio equipment placed on the Cypriot market is governed by the Radio Communications (Radio Equipment) (Basic) Regulations of 2016, Κ.Δ.Π. 310/2016, made under the Radio Communications legislation and harmonising Directive 2014/53/EU, together with the first amending regulations of 2026, Κ.Δ.Π. 231/2026. The Department of Electronic Communications (Τμήμα Ηλεκτρονικών Επικοινωνιών) of the Deputy Ministry of Research, Innovation and Digital Policy publishes the basic regulation and all amending regulations together as the set in force for radio equipment. The instrument was published in the Official Gazette No. 2154 of 4 November 2016 under Part III(I). There is no Cypriot type approval; where a device has a radio function the RED conformity assessment is required in addition to the MDR route. The Cypriot text is in Greek with an unusable PDF encoding, so no article number is cited.
Source Urls
https://www.gov.cy/dmrid-dec/documents/kanonismoi/2-oi-peri-radioepikoinonion-radioexoplismos-kanonismoi/
https://www.gov.cy/media/sites/15/2024/03/2KDP310_2016.pdf
Source Binding
reviewed
Id
department-of-environment-weee-batteries-epr
Name
Department of Environment extended producer responsibility for WEEE and batteries
Category
Environmental And Batteries
Status
Mandatory Pre Market
Object
Producer Or Authorised Representative
Note
Cyprus regulates extended producer responsibility by legislation for four waste streams — packaging, waste electrical and electronic equipment, batteries and accumulators, and tyres; applications for collective and individual systems are submitted to the Department of Environment (Τμήμα Περιβάλλοντος) and the resulting permits are signed by the Minister of Agriculture, Rural Development and Environment, with regular inspections of the systems. The WEEE stream is harmonised by the Waste (Waste Electrical and Electronic Equipment) Regulations of 2015, Κ.Δ.Π. 73/2015, under which those who place electrical and electronic equipment on the market are obliged, collectively or individually, to bear the cost of managing their products once they become waste, and the Department applies the Union target of separate collection for that stream on the Directive 2012/19/EU basis. For batteries and accumulators the Department keeps a register of producers and publishes the annual producer registration application. Which electrical and electronic equipment is inside the stream, and the medical-device exclusions that apply to it, are recorded on the Union rows of this atlas rather than restated here.
Source Urls
https://www.moa.gov.cy/moa/environment/environmentnew.nsf/page21_gr/page21_gr?OpenDocument=
Source Binding
reviewed
Id
weights-and-measures-service-legal-metrology
Name
Weights and Measures Service — legal metrology authority
Category
Legal Metrology
Status
Mandatory For Use Site
Object
In Use Device Inspection
Note
The Weights and Measures Service (Υπηρεσία Μέτρων και Σταθμών) of the Ministry of Energy, Commerce and Industry states on its page that it 'is the competent authority for the application of the Weights and Measures legislation', with the aim of securing the accuracy of measurements both in commercial and in scientific measurement. Its listed activities are verification of fuel-dispenser meters, of meters installed on fuel delivery tankers, of weighbridges of 3 t and above and of scales below 3 t, reference testing of prepacked goods for net content and marking, complaint investigation and the drafting of weights-and-measures legislation. A device with a measuring function therefore meets the Cypriot legal-metrology regime at the point of use and in trade rather than through a separate pre-market device certificate; the metrological function itself is assessed inside the CE route.
Source Urls
https://www.gov.cy/meci/ypiresia-metron-kai-stathmon
Source Binding
reviewed
Id
department-of-labour-inspection-ionizing-radiation
Name
Department of Labour Inspection — ionizing radiation protection and nuclear safety
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Radiation Equipment Source And Use Site
Note
The Department of Labour Inspection (Τμήμα Επιθεώρησης Εργασίας) of the Ministry of Labour and Social Insurance states that protection of the health of workers, the public and patients, and protection of property and the environment, from the hazards of exposure to ionizing radiation or of the release or dispersal of radioactive material or radioactive contamination of the environment, 'ρυθμίζεται από ειδική νομοθεσία που εφαρμόζει το Τμήμα Επιθεώρησης Εργασίας για Ακτινοπροστασία και Πυρηνική Ασφάλεια'. A medical device that emits ionizing radiation therefore adds this use-site regime to the CE route. That special legislation was not opened, so no instrument number or article is cited.
Source Urls
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/F76E865526298C1DC2257E850019F178?OpenDocument=
Source Binding
reviewed
Id
department-of-labour-inspection-non-ionizing-radiation
Name
Department of Labour Inspection — non-ionizing radiation in the working environment
Category
Non Ionizing Radiation
Status
Mandatory For Use Site
Object
Radiation Emitting Electronic Product
Note
The same Department of Labour Inspection page states that protection of workers and other persons in the working environment from the hazards of exposure to non-ionizing radiation — electromagnetic fields and artificial optical radiation — 'διέπεται γενικά από τους Νόμους για Ασφάλεια και Υγεία στην Εργασία και ειδικούς Κανονισμούς που έχουν εκδοθεί κάτω απο τους Νόμους αυτούς'. Devices whose clinical or diagnostic use exposes staff to electromagnetic fields or artificial optical radiation therefore carry an occupational use-site duty in addition to the CE route. The specific regulations were not opened, so no instrument number or article is cited.
Source Urls
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/F76E865526298C1DC2257E850019F178?OpenDocument=
Source Binding
reviewed

Official Sources

Authority
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Topic
Notification of medical devices placed on the Cypriot market — CYMDA spreadsheet filed to cymda@mphs.moh.gov.cy
Url
https://www.gov.cy/moh-mphs/documents/notification-of-medical-devices/
Authority
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Topic
Decree No. 6 language requirements for medical and in-vitro diagnostic devices — English and/or Greek, Greek compulsory for use by non-healthcare professionals, enforced under Law 225(I)/2022
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%91%CE%9D%CE%91%CE%9A%CE%9F%CE%99%CE%9D%CE%A9%CE%A3%CE%97-%CE%91%CE%A0%CE%9F-CYMDA-%CE%93%CE%99%CE%91-%CE%93%CE%9B%CE%A9%CE%A3%CE%A3%CE%99%CE%9A%CE%95%CE%A3-%CE%91%CE%A0%CE%91%CE%99%CE%A4%CE%97%CE%A3%CE%95%CE%99%CE%A3.pdf
Authority
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Topic
Notice of 6 November 2025 on recording the importer's details on medical devices and other distributor and importer duties — restates Decree No. 7 of the Official Gazette of 5 January 2012
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%91%CE%9D%CE%91%CE%9A%CE%9F%CE%99%CE%9D%CE%A9%CE%A3%CE%97-%CE%93%CE%99%CE%91-%CE%A4%CE%97%CE%9D-%CE%91%CE%9D%CE%91%CE%93%CE%A1%CE%91%CE%A6%CE%97-%CE%A4%CE%A9%CE%9D-%CE%A3%CE%A4%CE%9F%CE%99%CE%A7%CE%95%CE%99%CE%A9%CE%9D-%CE%A4%CE%9F%CE%A5-%CE%95%CE%99%CE%A3%CE%91%CE%93%CE%A9%CE%93%CE%95%CE%91-6-11-25.pdf
Authority
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Topic
Notice of 8 January 2026 — compulsory use of the first four EUDAMED modules from 28 May 2026 under Commission Decision (EU) 2025/2371
Url
https://www.gov.cy/media/sites/190/2026/07/%CE%A5%CF%80%CE%BF%CF%87%CF%81%CE%B5%CF%89%CF%84%CE%B9%CE%BA%CE%AE-%CF%87%CF%81%CE%AE%CF%83%CE%B7-%CF%84%CE%B5%CF%83%CF%83%CE%AC%CF%81%CF%89%CE%BD-%CE%B5%CE%BD%CE%BF%CF%84%CE%AE%CF%84%CF%89%CE%BD-%CF%84%CE%B7%CF%82-EUDAMED.pdf
Authority
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Topic
Definitions and classification of medical devices — MDR Article 2(1) adopted as the Cypriot definition
Url
https://www.gov.cy/moh-mphs/documents/orismoi-kai-katigoriopoiisi-iatrotechnologikon-proionton-el/
Authority
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Topic
Commencement of a clinical investigation or performance study in Cyprus — CYMDA authorisation and the National Bioethics Committee opinion
Url
https://www.gov.cy/moh-mphs/documents/enarxi-klinikis-ereynas-meleti-epidoseon-stin-kypro/
Authority
Αρμόδια Αρχή Ιατροτεχνολογικού Εξοπλισμού (CYMDA), Ministry of Health
Topic
Registration for IVD products — CYMDA application form
Url
https://www.gov.cy/moh-mphs/documents/registration-for-ivd-products/
Authority
EUR-Lex
Topic
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
Url
https://eur-lex.europa.eu/eli/dir/2014/35/oj
Authority
EUR-Lex
Topic
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
Url
https://eur-lex.europa.eu/eli/dir/2014/30/oj
Authority
EUR-Lex
Topic
Regulation (EU) 2017/745 (MDR) — Annex I electrical-safety and electromagnetic-compatibility essential requirements
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Authority
Τμήμα Ηλεκτρομηχανολογικών Υπηρεσιών (Electrical and Mechanical Services Department), Ministry of Transport, Communications and Works
Topic
Electromagnetic Compatibility Regulations Κ.Δ.Π. 181/2017 and Κ.Δ.Π. 589/2020
Url
https://www.mcw.gov.cy/mcw/ems/ems.nsf/All/2E8259A0BADF8D1B4325795E0020F6F8?OpenDocument=
Authority
Τμήμα Ηλεκτρονικών Επικοινωνιών (Department of Electronic Communications), Deputy Ministry of Research, Innovation and Digital Policy
Topic
Radio Communications (Radio Equipment) Regulations — basic regulation Κ.Δ.Π. 310/2016 with the first amendment Κ.Δ.Π. 231/2026
Url
https://www.gov.cy/dmrid-dec/documents/kanonismoi/2-oi-peri-radioepikoinonion-radioexoplismos-kanonismoi/
Authority
Τμήμα Ηλεκτρονικών Επικοινωνιών (Department of Electronic Communications), Deputy Ministry of Research, Innovation and Digital Policy
Topic
Radio Communications (Radio Equipment) (Basic) Regulations of 2016, Κ.Δ.Π. 310/2016, Official Gazette No. 2154 of 4 November 2016
Url
https://www.gov.cy/media/sites/15/2024/03/2KDP310_2016.pdf
Authority
Τμήμα Περιβάλλοντος (Department of Environment), Ministry of Agriculture, Rural Development and Environment
Topic
Extended producer responsibility for packaging, WEEE, batteries and accumulators, and tyres — permits signed by the Minister; WEEE Regulations Κ.Δ.Π. 73/2015; register of producers of batteries and accumulators
Url
https://www.moa.gov.cy/moa/environment/environmentnew.nsf/page21_gr/page21_gr?OpenDocument=
Authority
Υπηρεσία Μέτρων και Σταθμών (Weights and Measures Service), Ministry of Energy, Commerce and Industry
Topic
Competent authority for the Weights and Measures legislation — verification of weighbridges and scales and reference testing of prepacked goods
Url
https://www.gov.cy/meci/ypiresia-metron-kai-stathmon
Authority
Τμήμα Επιθεώρησης Εργασίας (Department of Labour Inspection), Ministry of Labour and Social Insurance
Topic
Ionizing radiation protection and nuclear safety, and non-ionizing radiation in the working environment
Url
https://www.mlsi.gov.cy/mlsi/dli/dliup.nsf/All/F76E865526298C1DC2257E850019F178?OpenDocument=

Keep researching this market

View the Cyprus resource hub →

Continue with this market

Need to apply Cyprus's requirements to a product?

Confirm the current Ministry of Health pathway, evidence, and local-role details for the actual device before filing.

Pricing

Changes after registration

Approval validity & renewal

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

Authority & regime

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

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

CYMDA is the market-surveillance authority under Cypriot law and a member of the European market-surveillance group

Classification rules

Four medical device classes (I, IIa, IIb, III) and four IVD classes (A, B, C, D)

Clinical investigation & performance

A clinical investigation or performance study requires a licence from CYMDA

Device definition & scope

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

Economic-operator roles

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

Establishment, import & distribution

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

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

Label, IFU & language

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

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

Legal basis & guidance

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

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

Manufacturer PMS

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

Official forms & portals

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

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

QMS, audit & inspection

CYMDA inspects manufacturers, importers and distributors and their products

Recall, FSCA & market surveillance

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

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

Missing importer details or a missing Greek IFU for lay use makes a device non-compliant on inspection

Registration pathways

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

Reliance & recognition

Cyprus approvals and evidence in other markets (0 records)

Prior approvals and evidence for Cyprus (3 records)

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

FDA 510(k)/PMA

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

Review clocks

The Notifying Authority decides on a conformity assessment body's application within 30 days and notifies it within 10 days

Hierarchical appeal against administrative fines or cost recovery: 30 days to lodge, Minister decides within 90 days, court within 75 days

Hierarchical appeal against market-surveillance measures: 15 days to lodge, Minister decides within 60 days, court within 75 days

Restrictive market-surveillance measures are notified within 15 days and preceded by a hearing period of at least 10 working days

Standards, testing & ancillary approvals

Conformity may be presumed from correspondence with the relevant harmonised European standards

UDI, listing & traceability

Four EUDAMED modules have been mandatory since 28 May 2026

Importers must register in EUDAMED and product traceability is required

Vigilance & incident reporting

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

Suppliers must keep complaint records and inform the manufacturer

Healthcare professionals may report incidents to CYMDA by user report form or Microsoft Forms

Related structured datasets

More Cyprus medical device resources