NNGYK market access

Hungary medical device registration resources

Research NNGYK registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Hungary medical device resource.

5 free resources24/25 requirements coveredAug 2026 fees reviewed

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Hungary requirements.

Medical device regulation news

Follow recent National Center for Public Health and Pharmacy (NNGYK) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary NNGYK risk class with official rule references.

Government registration fees

Review current NNGYK application, review, and renewal fees.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 45 source-linked facts →

24 of 25 research dimensions currently covered · 29 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

Competent authority: NNGYK (Nemzeti Népegészségügyi és Gyógyszerészeti Központ, National Center for Public Health and Pharmacy), through its Medical Device Department (Orvostechnikai Főosztály, site still brand…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National MDR implementation decree: The MDR is directly applicable EU law in Hungary; the national implementation for medical devices was carried out by amending Decree 4/2009. (III. 17.) EüM rendelet on medical devices (cons…
National IVDR implementation decree: The national implementation for in vitro diagnostic devices was carried out by amending Decree 8/2003. (III. 13.) ESzCsM rendelet on in vitro diagnostic devices.

4 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Nursing technical devices covered by distributor notification: Nursing technical devices (ápolási technikai eszköz) within the meaning of 4/2009. (III. 17.) EüM rendelet 17. § (7) fall under the national distributor notification duty even though they a…
National medical-aids category (non-device aids): Hungary maintains a national product category of medical aids (gyógyászati segédeszköz), including aids that are not medical devices; for non device medical aids the classification pointer…

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

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

1 maintained scheme

Checked 2026-08-26

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D05

Registration pathways

Verified

Mandatory EUDAMED Actor registration: Until NNGYK officially declares each EUDAMED module functional, use of the EUDAMED Actor registration module is mandatory in Hungary for the registration of economic operators, fulfilling 4…
NOR registration scope for HU manufacturers and authorised representatives: Manufacturers and authorised representatives established in Hungary are entered in the national device register (NOR): this covers manufacture of Class I and custom made devices, assembly o…

5 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

EU CE under MDR/IVDR — single market validity: target: geo:hun · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

1 source-linked fact

Checked 2026-08-30

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D07

Economic-operator roles

Verified

Importer role triggers EUDAMED registration: An operator that brings the device into the EU market from outside the EU in the course of commercial activity also qualifies as an importer and has a registration duty in the EU device dat…

1 source-linked fact

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Distributor notification content including basic UDI-DI: The distributor notification must state the data elements listed in 4/2009. (III. 17.) EüM rendelet 17. § (3) a)–g), including the basic UDI DI of each distributed device per MDR Annex VI P…

1 source-linked fact

Checked 2026-08-25

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D09

Dossier requirements

Verified

Distributor notification attachments: The distributor notification under 17. § (3) must attach the device's Hungarian and English instructions for use, the EU declaration of conformity, the certificate where conformity assessme…
EUDAMED Actor registration uploads: EUDAMED Actor registration requires uploading a declaration named 'Declaration on Information Security Responsibilities', the LAA designation documents, and for non EU manufacturers an extr…

3 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

e-ügyintézés submission channel: National filings are submitted through Hungarian electronic administration (e ügyintézés under 2015. évi CCXXII. törvény, using Company Gate/cégkapu); the deviation permit application docum…
Current distributor notification form: The current official form for notifying MDR devices for distribution is 'Kérelem MDR szerinti orvostechnikai eszköz bejelentéséhez' dated 2025.09.15., published on the NNGYK distributor reg…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Hungarian language for end-user information: The information specified in MDR Annex I point 23 and the implant card per MDR Article 18 must be available to the end user in Hungarian.

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Periodic review duty: Devices listed in Annex 13 of 4/2009. (III. 17.) EüM rendelet (25 device groups) must undergo periodic technical review (időszakos felülvizsgálat) at intervals of 1, 2 or 3 years depending…
Periodic review organization authorization: Periodic technical reviews may only be performed by organizations holding a valid NNGYK decision (authorization) issued under 4/2009. (III. 17.) EüM rendelet 27. § (4).

2 source-linked facts

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Verified

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
2/2017. (I. 17.) NMHH rendelet on radio equipment, with Hungarian-language duties: Wireless / radio

9 maintained overlays

Checked 2026-09-07

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D14

Fees

Verified

EUDAMED actor registration: HUF 97,065
Custom-made-device manufacturer registration: HUF 8,100

11 maintained fee lines · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Actor certificate invalidation on change: When registered actor data change and the change is reported, the previously issued official certificate (hatósági bizonyítvány) of the EUDAMED Actor registration loses its validity.
Deviation permit territorial and temporal scope: A deviation permit (eltérési engedély) from conformity assessment procedures is granted for a defined period only and is valid only on the territory of one country (Hungary).

2 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Actor data changes within 7 days: Economic operators must report any change in their registered EUDAMED Actor data within 7 days of occurrence, via cégkapu e paper referencing the original case number (fee 21,600 Ft, fee ta…
Distributor data changes within 90 days: Distributors must report changes to their notified data — including newly distributed devices — within 90 days of the change occurring (fee 21,600 Ft).

2 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Central Implant Register reporting including UDI: Since 1 January 2014, healthcare providers must report implantation related interventions (implantation, removal, exchange) to the Central Implant Register (Központi Implantátumregiszter, K…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

National authorization for clinical investigations: Clinical investigations of medical devices in Hungary may be conducted only on the basis of an NNGYK authorizing decision, under the conditions specified in that decision and the approved i…
ETT TUKEB opinion prerequisite: A supporting opinion of the ETT TUKEB (ethics committee) must be attached to the clinical investigation application; it is a condition for issuing the investigation authorization.

3 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

MD deviation permit (MDR Art. 59): On duly justified public health/patient safety grounds, with conformity assessment already in progress and a determinable end date, NNGYK may permit deviation from conformity assessment pro…
IVD deviation permit (IVDR Art. 54): Where the conditions of IVDR Article 54(1) exist, NNGYK may upon application permit that the device be placed on the market without the conformity assessment procedures of IVDR Article 48 h…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-market surveillance reporting (Arts. 83-86): Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…

1 source-linked fact

Checked 2026-08-29

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D22

Vigilance & incident reporting

Verified

Incident reporting by providers; NNGYK informs manufacturer within 8 days: Healthcare providers and health workers must report incidents electronically in the format published by NNGYK; patients may also submit reports; NNGYK informs the manufacturer or authorised…
Incident reporting channel and forms: Until the EUDAMED vigilance modules become functional, incidents and accidents (including those arising in clinical investigations) are reported to the NNGYK mailbox amd.vig@nngyk.gov.hu st…

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Free Sale Certificates: NNGYK issues Free Sale Certificates (FSC) and English language certificates for devices manufactured in Hungary and distributed outside the EU (contact fsc@nngyk.gov.hu; fee per fee table i…
Market surveillance duty: Market surveillance (piacfelügyelet) of medical devices and IVDs in Hungary is a statutory duty of the NNGYK Medical Device Department.

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Advertising prohibitions for medical aids: Medical aids receiving social health insurance (TB) funding may not be advertised (except under Gyftv. 17. § (4a)), and medical aids that may not lawfully be marketed in Hungary may not be…
Mandatory advertising warning text: Advertisements for medical aids must carry the mandatory warning (per 3/2009 EüM rendelet 4. § (1)): 'A kockázatokról olvassa el a használati útmutatót, vagy kérdezze meg kezelőorvosát!' (R…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Remedy against rejecting decisions: NNGYK provides a remedy procedure (jogorvoslati eljárás) against rejecting decisions; stated for rejections of clinical investigation applications, e.g. for omitted fee payment.
Ákr. treatment of Actor data upload: NNGYK treats the EUDAMED Actor data upload as an application (kérelem) under the general administrative procedure code (2016. évi CL. törvény, Ákr.); deficiencies are communicated by decisi…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (11 lines) →

NNGYK registration fees in HUF · reviewed 2026-08-25

Fee line	Amount	Provenance
EUDAMED actor registration	HUF 97,065	Verified
Custom-made-device manufacturer registration	HUF 8,100	Verified
Conformity-assessment-body designation	HUF 167,000	Verified
Certificate for aids for individual measures	HUF 189,000–508,950	Verified