Pure Global AI
NNGYK · Europe

Hungary medical device regulatory resources

Every Hungary dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources23/25 topics with recordsAug 2026 fees reviewed
Run the classification agent

Everything we track for Hungary

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 46 source-linked facts →

23 of 25 research dimensions currently covered · 31 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
NNGYK (Nemzeti NĂ©pegĂ©szsĂ©gĂŒgyi Ă©s GyĂłgyszerĂ©szeti Központ, National Center for Public Health and Pharmacy), through its Medical Device Department (Orvostechnikai FƑosztĂĄly, site still brand

1 source-linked fact
Checked 2026-08-25
Open details →
D02

Legal basis & guidance

Verified
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.
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.) EĂŒM rendelet on medical devices (cons

4 source-linked facts
Checked 2026-08-25
Open details →
D03

Device definition & scope

Verified
National medical-aids category (non-device aids)
Hungary maintains a national product category of medical aids (gyĂłgyĂĄszati segĂ©deszköz), including aids that are not medical devices; for non device medical aids the classification pointer

Nursing technical devices covered by distributor notification
Nursing technical devices (ĂĄpolĂĄsi technikai eszköz) within the meaning of 4/2009. (III. 17.) EĂŒM rendelet 17. § (7) fall under the national distributor notification duty even though they a

2 source-linked facts
Checked 2026-08-25
Open details →
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
Open details →
D05

Registration pathways

Verified
Custom-made manufacturer NOR registration
Manufacturers of custom made devices must register in NOR; the duty has applied since 26 May 2021 independently of NEAK (health insurance) accounting, and manufacturing activity cannot be l

Distributor NOR notification before distribution
A distributor established in Hungary must notify the authority (NNGYK) before starting to distribute devices on the Hungarian market; distributors are registered in the national register NO

5 source-linked facts
Checked 2026-08-25
Open details →
D06

Reliance & recognition

Verified
NMPA certificate does not replace EU conformity assessment
statement: For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and proce

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

2 source-linked facts
Checked 2026-09-15
Open details →
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
Open details →
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.) EĂŒM 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
Open details →
D09

Dossier requirements

Verified
Clinical investigation application checklist
Clinical investigation applications follow an official checklist of roughly 30 documents aligned with MDCG 2021 08 and MDCG 2021 28, submitted via e ĂŒgyintĂ©zĂ©s with the SRN stated; the inst

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

3 source-linked facts
Checked 2026-08-25
Open details →
D10

Official forms & portals

Verified
Current distributor notification form
The current official form for notifying MDR devices for distribution is 'KĂ©relem MDR szerinti orvostechnikai eszköz bejelentĂ©sĂ©hez' dated 2025.09.15., published on the NNGYK distributor reg

e-ĂŒgyintĂ©zĂ©s submission channel
National filings are submitted through Hungarian electronic administration (e ĂŒgyintĂ©zĂ©s under 2015. Ă©vi CCXXII. törvĂ©ny, using Company Gate/cĂ©gkapu); the deviation permit application docum

2 source-linked facts
Checked 2026-08-25
Open details →

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
Open details →
D12

QMS, audit & inspection

Verified
Periodic review duty
Devices listed in Annex 13 of 4/2009. (III. 17.) EĂŒM rendelet (25 device groups) must undergo periodic technical review (idƑszakos felĂŒlvizsgĂĄlat) 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.) EĂŒM rendelet 27. § (4).
2 source-linked facts
Checked 2026-08-25
Open details →
D13

Standards, testing & ancillary approvals

Unresolved
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
Open details →
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
Open details →
D15

Review clocks

Unresolved
Class I · Self-declaration (no notified body)
0 days
1 maintained pathway · 1 related fact
Checked 2026-08-29
Open details →
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 (hatĂłsĂĄgi bizonyĂ­tvĂĄny) 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
Open details →

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
Open details →
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 ImplantĂĄtumregiszter, K

1 source-linked fact
Checked 2026-08-25
Open details →
D19

Clinical investigation & performance

Verified
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.
IVD performance-evaluation devices: notify but no marketing
IVDs intended for performance evaluation are subject to notification to the authority but may not be placed on the market.
3 source-linked facts
Checked 2026-08-25
Open details →
D20

Special access & derogation

Verified
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

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

2 source-linked facts
Checked 2026-08-25
Open details →
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
Open details →
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
Open details →
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 (piacfelĂŒgyelet) 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
Open details →
D24

Advertising, claims & promotion

Verified
Mandatory advertising warning text
Advertisements for medical aids must carry the mandatory warning (per 3/2009 EĂŒM rendelet 4. § (1)): 'A kockĂĄzatokrĂłl olvassa el a hasznĂĄlati ĂștmutatĂłt, vagy kĂ©rdezze meg kezelƑorvosĂĄt!' (R

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

2 source-linked facts
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Remedy against rejecting decisions
NNGYK provides a remedy procedure (jogorvoslati eljĂĄrĂĄs) 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 (kĂ©relem) under the general administrative procedure code (2016. Ă©vi CL. törvĂ©ny, Ákr.); deficiencies are communicated by decisi

2 source-linked facts
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (11 lines) →

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

Fee lineAmountProvenance
EUDAMED actor registrationHUF 97,065Verified
Custom-made-device manufacturer registrationHUF 8,100Verified
Conformity-assessment-body designationHUF 167,000Verified
Certificate for aids for individual measuresHUF 189,000–508,950Verified
7 more fee lines on the full schedule · 11 of 11 rows source-verified

Registration timeline

Full registration timeline →

National Public Health and Medical Officer Service (NNGYK) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU MDR classification

Class / pathwayReview clockPlanning totalProvenance
Class I(Self-declaration (no notified body))0 days6-9 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(0 days)
  5. 5Registration Approval(1-2 weeks)
Continue with this market

Turn Hungary research into practical work

The target market is carried into each tool. Add the product, evidence, or regulatory change you want to assess.

View every AI workpaper →

Build a reusable product master

Structure company, product, model, approval, certificate, and evidence facts before starting Hungary work.

Hungary market-launch workpaper

Connect the NNGYK route, evidence, labels, local role, timing, and dependencies to a wider launch plan.

Hungary dossier reuse and delta

Compare an existing authorization and evidence set against NNGYK administrative, testing, labeling, and dossier needs.

Hungary change notification workpaper

Map a product or manufacturing change to NNGYK evidence, notification, timing, and implementation questions.

Hungary regulatory change impact

Assess a current NNGYK update against one product and turn it into an owner-ready action workpaper.

Hungary cybersecurity evidence review

Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Hungary (NNGYK).

Country hubs in other markets

Other Europe markets

AlbaniaArmeniaAustriaAzerbaijanBelarusBelgiumBosnia and HerzegovinaBulgariaCroatiaCyprusCzech RepublicDenmarkEstoniaEuropean UnionFinlandFranceGeorgiaGermanyGreeceIcelandIrelandItalyKazakhstanLatviaLiechtensteinLithuaniaLuxembourgMaltaMoldovaMontenegroNetherlandsNorth MacedoniaNorwayPolandPortugalRomaniaRussiaSerbiaSlovakiaSloveniaSpainSwedenSwitzerlandTurkeyUkraineUnited KingdomAll 114 markets →
DJ Fang
Entering the Hungary market?
Local representation, NNGYK submissions, and lifecycle maintenance — handled with an expert.
Pricing