Explore the IVD requirements currently available for Hungary, organized by topic and linked to official sources.
Source-linked rules for common changes to a registered IVD. Read the scope and conditions with each rule; unverified details are listed separately.
A change to the registered brand name and a change to logo artwork can follow different rules. The legal manufacturer, device design and intended purpose remain the same.
A source-verified answer for this specific scenario is not yet published.
The same legal manufacturer changes its name, potentially alongside the device brand. A transfer to another legal entity is a separate question; permission to combine filings needs its own evidence.
A source-verified answer for this specific scenario is not yet published.
An office address change for the same legal entity, potentially alongside name and brand changes. This does not cover moving a factory or manufacturing site, and a combined filing cannot be assumed.
A source-verified answer for this specific scenario is not yet published.
Check which identifier actually changes. A commercial catalogue, REF or order code is not automatically a device model, registered identifier, GTIN or UDI-DI. Rules for one identifier do not establish the route for another.
A source-verified answer for this specific scenario is not yet published.
A real change of legal manufacturer, registration holder or owner. This differs from renaming the same entity; a change of local representative or importer alone does not establish a registration transfer route. Where other changes occur with the transfer, the exact combination and sequence need separate evidence.
A source-verified answer for this specific scenario is not yet published.
Changes to brand, manufacturer name, office address and reference codes may occur together, including with a real transfer to another legal manufacturer, registration holder or owner. Assess transfer with each single change, and transfer with brand plus reference, manufacturer name plus reference, or office address plus reference changes: seven transfer combinations in total. Evidence must establish the exact combination and the order of filings and approvals. These combinations and their sequence are not all verified by the rules below; a rule for one change does not prove that a single application, fee or review period covers the combination.
A source-verified answer for this specific scenario is not yet published.
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?
IVDs intended for performance evaluation are subject to notification to the authority but may not be placed on the market.
Which evidence, local deltas, formats, and signatures are required?
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).
What regulator fee applies to this class, route, event, and date?
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 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.
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.
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 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?
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.
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
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.
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)).
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
What is reportable, by whom, where, in what format, and by what deadline?
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.
No maintained 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.
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
✅
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.
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
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.
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
