Explore the medical device requirements currently available for Hungary, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
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!' (Read the instructions for use about the risks, or ask your treating physician.)
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 advertised; NNGYK/OGYÉI is the advertising-control authority under the Gyftv. (2006. évi XCVIII. tv.) and Grtv. (2008. évi XLVIII. tv.).
What expires, what is retained periodically, and when must renewal start?
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.
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).
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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 table II.5), and must simultaneously make the change in EUDAMED.
Distributors must report changes to their notified data — including newly distributed devices — within 90 days of the change occurring (fee 21,600 Ft).
Which clinical or IVD performance evidence or study is required and accepted?
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.
IVDs intended for performance evaluation are subject to notification to the authority but may not be placed on the market.
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 investigation plan, per 33/2009. (X. 20.) EüM rendelet 1. § (3) and 16. § (1).
Is the product a device, IVD, accessory, software, or borderline product locally?
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 is 14/2007 EüM rendelet 2. § (4) h).
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 are not medical devices under the MDR.
National scope extension beyond the MDR device definition.
Which evidence, local deltas, formats, and signatures are required?
Clinical investigation applications follow an official checklist of roughly 30 documents aligned with MDCG 2021-08 and MDCG 2021-28, submitted via e-ügyintézés with the SRN stated; the instructions for use must be supplied in Hungarian and in the original English.
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 assessment requires one, and a registration certificate where the manufacturer is not yet registered in EUDAMED.
EUDAMED Actor registration requires uploading a declaration named 'Declaration on Information Security Responsibilities', the LAA designation documents, and for non-EU manufacturers an extract of the authorised-representative contract.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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 database (EUDAMED).
Which establishment licences, importer permissions, and distribution controls apply?
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 Part C point 1.
What regulator fee applies to this class, route, event, and date?
If the fee payment is omitted, the application/notification is rejected (visszautasítás); stated for clinical investigation applications and notifications to NNGYK.
Administrative service fees for fee-charged device/IVD procedures must be transferred to the NNGYK bank account from 31 July 2023; the payment reference must start with 'ORVOSTECHNIKA' followed by the case (APP) number, and proof of payment must be attached to the submission.
Effective from 2023-07-31
Distinct legal rule on payment mechanics; the individual fee amounts are recorded as typed findings under government-fees.
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
Which current law, regulation, guidance, and transition provisions apply?
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.
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 (consolidated text maintained on NJT).
Consolidated on NJT most recently with 32/2025. (VIII. 11.) BM rendelet; the MDR-implementing amendment package was 35/2021. (VIII. 17.) EMMI rendelet.
NNGYK (Nemzeti Népegészségügyi és Gyógyszerészeti Központ), Medical Device Department (Orvostechnikai Főosztály); official site ogyei.gov.hu
National filings go through Hungarian e-administration (e-ügyintézés under 2015. évi CCXXII. törvény, Company Gate cégkapu); economic-operator registration uses the mandatory EUDAMED Actor module; current national forms are published on the ogyei.gov.hu Orvostechnika pages
Corrects the baseline fact: the national legal delta and the actual submission surfaces (cégkapu/e-ügyintézés, EUDAMED Actor module, ogyei.gov.hu forms) are now identified from official NNGYK pages.
Detailed rules for periodic technical reviews (időszakos felülvizsgálat) of devices are set by Decree 12/2025. (III. 31.) BM rendelet, in force from 1 April 2025, replacing the earlier 34/2009 EüM rendelet.
Effective from 2025-04-01
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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 (Art. 84). Class I devices require a post-market surveillance report summarising results and conclusions (Art. 85); class IIa, IIb and III devices require a periodic safety update report (PSUR) per device or category, updated at least annually for class IIb and III devices and at least every two years for class IIa devices, forming part of the technical documentation (Art. 86).
Effective from 2021-05-26
Which current form, portal, account, and submission package must be used?
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 registration page.
National filings are submitted through Hungarian electronic administration (e-ügyintézés under 2015. évi CCXXII. törvény, using Company Gate/cégkapu); the deviation-permit application document must be completed and sent via e-ügyintézés, with large files via transfer.ogyei.gov.hu.
Submission portal referenced on the page: https://ogyei.gov.hu/eugyintezes.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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 on the group; the duty rests on the provider handing over the device and on the operator.
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).
Which recall, FSCA, notice, and authority-coordination duties apply?
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 item II.6).
Market surveillance (piacfelügyelet) of medical devices and IVDs in Hungary is a statutory duty of the NNGYK Medical Device Department.
Which registration, notification, listing, reliance, or conformity route applies?
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 lawful without registration.
Effective from 2021-05-26
Official form: rendelésre_készült_gyártó_reg_kérelem_v12.xlsx.
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 NOR, not in EUDAMED.
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 4/2009 EüM rendelet 17. § (1), MDR Article 31, 8/2003 ESzCsM rendelet 7/A. § (1) and IVDR Article 27.
SRN example format on the page: HU-MF-123456789; registration via the EUDAMED webgate with EU Login; NNGYK issues an official certificate (hatósági bizonyítvány) via cégkapu.
IVD notification/registration under 8/2003. (III. 13.) ESzCsM rendelet 7/A. § uses an official notification form with attachments that vary by IVD tier; for general IVDs the manufacturer's declaration of conformity per Annex 3 of the decree must be attached.
Changes to notified data are submitted on the same form.
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 of systems and procedure packs, and sterilization, with a Class I declaration of competence; OGYÉI enters the data into EUDAMED. An administrative service fee is payable for the registration.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
Prior approval / evidence record
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
Prior approval / evidence record
País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, Sweden
Yes
The Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.
None published — the TUPA period is set by class, not by origin
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
geo:hun
EU CE under MDR/IVDR
Single Market Validity
direct
Product Marketing
Yes
No
No
Hungary states MDR direct applicability on its own regulatory page and names the two national implementing decrees, 4/2009 (III. 17.) EüM rendelet for devices and 8/2003 (III. 13.) ESzCsM rendelet for IVDs. Their content is notification and registration, not re-assessment.
Prior approval / evidence record
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
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 procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
hungary
All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes
No Reliance Route
none
Product Marketing
null
null
Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.
What review, validation, and applicant stop-clock rules apply?
The authorization procedure for clinical investigations under the MDR is not governed by the general administrative procedure code (2016. évi CL. törvény, Ákr.); its deadlines follow the special national rules (33/2009 EüM rendelet) and the MDR-derived timelines instead.
Distinct stop-clock-style legal rule; the concrete day counts are recorded as typed findings under registration-timelines.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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 having been carried out (deviation permit under 8/2003. (III. 13.) ESzCsM rendelet 4. § (1)).
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 procedures (eltérési engedély) under MDR Article 59(1) via 4/2009. (III. 17.) EüM rendelet 22. § (1); the permit may relate to a specific patient or be general for a manufacturer's specific device.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
NNGYK provides a remedy procedure (jogorvoslati eljárás) against rejecting decisions; stated for rejections of clinical investigation applications, e.g. for omitted fee payment.
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 decision (végzés) via cégkapu and are remedied by editing the original APP request in EUDAMED.
Which UDI, device listing, database, and traceability duties apply?
Since 1 January 2014, healthcare providers must report implantation-related interventions (implantation, removal, exchange) to the Central Implant Register (Központi Implantátumregiszter, KIR) at impreg.neak.gov.hu, operated by NEAK, within 8 days of the patient's discharge; the data list under Eütv. 101/C § a)–g) includes lot/serial number, manufacturer, distributor, the performing physician/provider and the device UDI.
Effective from 2014-01-01
The data list includes point g): the device UDI identifier; OGYÉI receives only a connection code (kapcsolati kód) for its procedures.
What is reportable, by whom, where, in what format, and by what deadline?
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 representative of the report, at the latest within 8 days of the report.
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 stating the case number (iktatószám) and CIV-ID; NNGYK publishes separate reporting forms for manufacturer, distributor and healthcare-provider reporters.
The separate per-role forms are published on the varatlan_esemeny_jelentes_formanyomtatvanyok page.
hungary:medical-device
hungary
EU MDR classes I, Is, Im, Ir, IIa, IIb and III
National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas.
i
Class I
low
is
Class Is
low
im
Class Im
low
ir
Class Ir
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
NNGYK
official-source-verified
eu:medical-device
Regulation (EU) 2017/745, Art. 51 and Annex VIII
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-26
Hungary
hungary
HU
🇭🇺
National Public Health and Medical Officer Service
NNGYK
europe
3
4-class (I, IIa, IIb, III) — EU MDR
class-i
Class I
low
Self-declaration (no notified body)
0
0
days
official-verified
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
6
9
months
No
No
Yes
FDA 510(k)/PMA
No
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file
Yes
EU Authorized Representative
No
ISO 13485 accepted as QMS evidence
5 years (CE certificate)
2026-08-29
partially-verified
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
2027-02-25
2026-08-29
EUR-Lex Regulation (EU) 2017/745 (MDR)
https://eur-lex.europa.eu/eli/reg/2017/745/oj
2026-08-25
EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110
2026-08-29
2026-08-29
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by NNGYK. Appoint a EU Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to NNGYK including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
NNGYK reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. NNGYK may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, NNGYK issues Hungary market authorization certificate.
1-2 weeks
✅
hungary
Hungary
HU
NNGYK
8100
8100
HUF
No
97065
97065
HUF
No
eudamed-actor-registration
EUDAMED actor registration
HUF
97065
HUF 97,065
Per registration
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
custom-made-manufacturer-registration
Custom-made-device manufacturer registration
HUF
8100
HUF 8,100
Per registration
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
cab-designation
Conformity-assessment-body designation
HUF
167000
HUF 167,000
Per designation
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
individual-measure-aids-certificate
Certificate for aids for individual measures
HUF
189000
189000
508950
HUF 189,000–508,950
Per certificate
Tiered by headcount: 189,000 / 276,000 / 508,950.
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
change-notification
Notification of changes
HUF
21600
HUF 21,600
Per notification
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
english-language-certificate
English-language certificate
HUF
47250
HUF 47,250
Per 60 products
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
deviation-permit
Deviation permit
HUF
81810
HUF 81,810
Per permit
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
clinical-performance-application
Clinical-investigation / performance-study application
HUF
243000
HUF 243,000
Per application
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
ionizing-radiation-investigation
Clinical investigation of devices with ionizing radiation
HUF
397845
HUF 397,845
Per application
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
distributor-notification
Distributor notification
HUF
89100
HUF 89,100
Per notification
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
article-74-1-notification
Notification under MDR Art. 74(1)
HUF
99000
HUF 99,000
Per notification
exact-current
official-verified
https://ogyei.gov.hu/eljarasi_dijak
Hungary OGYEI procedural fee table for medical devices
2026-08-25
2026-08-25
official-verified
Hungary OGYEI procedural fee table for medical devices
https://ogyei.gov.hu/eljarasi_dijak
2026-08-25
2026-08-25
exact-current
Yes
hungary
Hungary
high
lvd-medical-exclusion-mdr-electrical-safety
MDR electrical safety in place of the Low Voltage Directive
Medical Electrical Safety
Included In Medical Registration
Finished Device
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate for a medical device. Electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity.
candidate
emc-directive-disapplied-by-mdr
MDR electromagnetic compatibility in place of the EMC Directive
emc
Included In Medical Registration
Finished Device
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. EMC is therefore dossier evidence inside the CE route and not a separate national EMC conformity step.
candidate
nmhh-2-2017-radio-conformity-and-hungarian-language
2/2017. (I. 17.) NMHH rendelet on radio equipment, with Hungarian-language duties
Radio Spectrum
Mandatory If Feature
Radio Equipment
The Hungarian transposition of Directive 2014/53/EU, consolidated on the Nemzeti Jogszabálytár. 3. § (1) a) imports the safety requirements of the NGM decree on low-voltage electrical products expressly without applying its voltage limit, 3. § (1) b) imports the essential requirements of the NMHH EMC decree, and the same subsection ties radio-equipment design back to the national RoHS and WEEE decrees, so those obligations are not separable from the radio assessment. There is no Hungarian type approval. What is genuinely national is the language layer, and it is the part most often missed: 7. § (8) requires the manufacturer's name and contact address to appear in Hungarian on the equipment, its packaging or the accompanying documentation; 7. § (9) requires the operating instructions and safety information to accompany the equipment in both English and Hungarian; 15. § (3) and (5) require the EU declaration of conformity, and the simplified declaration, to be drawn up in Hungarian; and 7. § (14) lets the market-surveillance authority demand the whole compliance file in Hungarian. The market-surveillance authority is the Hivatal of the Nemzeti Média- és Hírközlési Hatóság, and 10. § (1) makes the distributor verify the Hungarian-language documentation before placing the equipment on the market.
candidate
korm-374-2012-rohs
374/2012. (XII. 18.) Korm. rendelet restricting hazardous substances in electrical equipment
Environmental And Batteries
Evidence Only No Separate Certificate
Electrical Electronic Medical Device
Consolidated to 22 July 2026 on the Nemzeti Jogszabálytár. 1. § (2) h) excludes active implantable medical devices, and 2. § now defines that term by reference to Regulation (EU) 2017/745 rather than the repealed directives, so the decree is current. The Hungarian-specific dates sit in the transitional text: the DEHP, BBP, DBP and DIBP marketing restriction under 3. § (1) applies to medical devices including in vitro diagnostics, and to monitoring and control instruments including industrial ones, only from 22 July 2021, while the general date is 22 July 2019; and the restriction does not reach medical devices placed on the market up to 21 July 2014, in vitro diagnostics up to 21 July 2016 or industrial monitoring and control instruments up to 21 July 2017. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.
candidate
korm-197-2014-weee-scope-and-producer-takeback
197/2014. (VIII. 1.) Korm. rendelet on waste electrical and electronic equipment
Environmental And Batteries
Mandatory If Feature
Electrical Electronic Medical Device
1. § (2) j) keeps out of scope medical devices and in vitro diagnostic medical devices expected to become infective before the end of their life cycle, together with active implantable medical devices; every other medical device inside the 1. melléklet categories is covered, with equipment defined in 2. § (1) 2. as working at up to 1000 V AC or 1500 V DC. The operative duty for a manufacturer is take-back rather than a certificate: under 4. § (1) the producer under individual compliance, or the concession company under collective compliance, must take back its own waste equipment and equipment of the same nature and function placed on the market by others, and 3. § lets the producer refuse a used device only where it presents a serious risk to the health or physical safety of the person taking it back, in which case the item is treated as waste. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.
candidate
korm-445-2012-batteries-regulation-implementation
445/2012. (XII. 29.) Korm. rendelet implementing the Batteries Regulation
Environmental And Batteries
Mandatory If Feature
Battery Producer Or Authorised Representative
Worth contrasting with neighbours that have not moved: the Hungarian battery decree, consolidated to 18 August 2026, has already been rebuilt around Regulation (EU) 2023/1542 rather than left on the repealed Directive 2006/66/EC. 2. § (2) makes the Regulation's definitions directly applicable inside the decree, 5. § (2) sets the collection duty by reference to Articles 59(3) and 60(3) of the Regulation, 14. § sets the producer's record-keeping content by reference to Article 75, 24/A. § designates the országos hulladékgazdálkodási hatóság as the control and competent authority for Article 69(2)–(5), and 30. § (1a) states in terms that the decree lays down the provisions needed to implement the Regulation. 15. § (1) requires the annual data return to that authority by 20 February following the reference year. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.
candidate
epr-80-2023-registration-before-first-placing
80/2023. (III. 14.) Korm. rendelet extended producer responsibility registration
Environmental And Batteries
Mandatory If Feature
Producer Or Authorised Representative
This is the single registration gate for a device that is electrical equipment or contains batteries, and its timing is stricter than the neighbouring one-month regimes. 23. § (1) requires the producer to apply to the országos hulladékgazdálkodási hatóság for entry in the register before starting activity with the circular product, declaring whether extended producer responsibility will be met collectively or individually under 8. §. 6. § a) adds a first step before that application: the producer must supply the 3. melléklet point 1 data to the concession company on its electronic platform, which is why practitioners describe the Hungarian entry as a double registration. 23. § (9) gives the authority 15 days to register a conforming application, 23. § (3) lets it register a producer as a collective performer of its own motion where no individual declaration or valid concession contract is produced, and 23. § (8) closes the obvious gap by making the extended producer responsibility fee payable on quantities placed on the market before registration was completed.
reviewed
kornyezetvedelmi-termekdij-no-longer-covers-eee-or-batteries
Környezetvédelmi termékdíj, which no longer reaches electrical equipment or batteries
Environmental And Batteries
Mandatory If Feature
Producer Or Authorised Representative
Recorded because the opposite is widely repeated and would send a manufacturer to the wrong authority. Hungary used to charge a környezetvédelmi termékdíj on electrical and electronic equipment and on batteries alongside the waste duties, but the tax authority's own current information booklet number 48, published 23 January 2026, lists only three categories of fee-liable product: egyéb kőolajtermék, egyéb műanyagtermék and egyéb vegyipari termék. Neither electrical and electronic equipment nor batteries appears anywhere in the fee-liable scope of that booklet. The residual product-fee mechanics still described there, such as the TKORNY notification to NAV within 15 days of starting the activity under Ktdt. 10. § (1), therefore bite only if the device business also places one of those three product groups on the Hungarian market; the waste-side obligation for the device itself now runs through the extended producer responsibility register and the concession company instead.
candidate
cmo-radiation-opinion-for-clinical-investigations
Chief Medical Officer radiation opinion for clinical investigations
Ionizing Radiation
Mandatory If Feature
Ionizing Radiation Device In Clinical Investigation
A clinical investigation with a device emitting ionizing radiation additionally requires the radiation documentation and the opinion of the országos tisztifőorvos (Chief Medical Officer) under 235/2009. (X. 20.) Korm. rendelet 3/A. cím and 37/C. § (1)-(2); such applications also carry the distinct II.10 fee (HUF 397,845).
candidate
EUR-Lex
Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope
https://eur-lex.europa.eu/eli/dir/2014/35/oj
EUR-Lex
EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive
https://eur-lex.europa.eu/eli/dir/2014/30/oj
EUR-Lex
RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates
https://eur-lex.europa.eu/eli/dir/2011/65/oj
EUR-Lex
WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register
https://eur-lex.europa.eu/eli/dir/2012/19/oj
EUR-Lex
Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register
https://eur-lex.europa.eu/eli/reg/2023/1542/oj
Nemzeti Jogszabálytár (njt.jog.gov.hu)
2/2017. (I. 17.) NMHH rendelet a rádióberendezésekről — 3. §, 7. §, 10. § and 15. §
https://njt.jog.gov.hu/jogszabaly/2017-2-20-3H
Nemzeti Jogszabálytár (njt.jog.gov.hu)
374/2012. (XII. 18.) Korm. rendelet — scope exclusions and the phthalate application dates for medical devices
https://njt.jog.gov.hu/jogszabaly/2012-374-20-22
Nemzeti Jogszabálytár (njt.jog.gov.hu)
197/2014. (VIII. 1.) Korm. rendelet — 1. § (2) j) medical-device exclusions, 2. § definitions and 3.–4. § take-back
https://njt.jog.gov.hu/jogszabaly/2014-197-20-22
Nemzeti Jogszabálytár (njt.jog.gov.hu)
445/2012. (XII. 29.) Korm. rendelet — 2. §, 5. §, 14.–15. §, 24/A. § and 30. § (1a) implementing Regulation (EU) 2023/1542
https://njt.jog.gov.hu/jogszabaly/2012-445-20-22
Nemzeti Jogszabálytár (njt.jog.gov.hu)
80/2023. (III. 14.) Korm. rendelet — 6. § and 23. § extended producer responsibility registration
https://njt.jog.gov.hu/jogszabaly/2023-80-20-22
Nemzeti Adó- és Vámhivatal (NAV)
Információs füzet 48. Környezetvédelmi termékdíj, 23 January 2026 — the fee-liable product list and the TKORNY notification
https://nav.gov.hu/pfile/file?path=/ugyfeliranytu/nezzen-utana/inf_fuz/2026/48.-Kornyezetvedelmi-termekdij-2026.-01.-23
OGYÉI
MDR clinical-investigation guide — ionizing-radiation devices, CMO opinion
https://ogyei.gov.hu/utmutato_az_mdr_szerinti_klinikai_vizsgalathoz
