Annex I — the product route to high-riskPríloha I — produktová cesta k vysokému riziku
Most AI Act guidance stops at Annex III. But an AI system can also be high-risk because it is a product — Article 6(1) — and then the answer depends on a sectoral act, not on the AI Act. This page lists all 20 of them, which section each sits in, and the question that decides your case. Väčšina výkladov AI Actu končí pri Prílohe III. Systém AI ale môže byť vysokorizikový aj preto, že je produktom — článok 6 ods. 1 — a vtedy o všetkom rozhoduje sektorový predpis, nie AI Act. Táto stránka uvádza všetkých 20, ktorý je v ktorej sekcii, a otázku, ktorá rozhodne tvoj prípad.
Annex I Section A. Art 6(1): the AI system is high-risk if it is a product (or a safety component of a product) covered by this act AND that product must undergo third-party conformity assessment under it. Section A is not covered by the Art 2(2) carve-out, so the full Chapter III regime applies.Príloha I sekcia A. Čl. 6 ods. 1: systém AI je vysokorizikový, ak je produktom (alebo bezpečnostným komponentom produktu) podľa tohto predpisu A ZÁROVEŇ ten produkt musí podľa neho prejsť posudzovaním zhody treťou stranou. Na sekciu A sa výnimka podľa čl. 2 ods. 2 nevzťahuje — uplatní sa celá kapitola III.
Toy Safety Directive
The question we do not answerIs this product a toy within the meaning of the Directive, and do harmonised standards fully cover it?Je tento produkt hračkou v zmysle smernice a pokrývajú ju harmonizované normy v plnom rozsahu?
- When a third party is involved
- EU type-examination by a notified body is required where no harmonised standards cover the toy, or where the manufacturer did not apply them (or applied them only in part).Skúška typu EÚ notifikovanou osobou sa vyžaduje, ak hračku nepokrývajú harmonizované normy, alebo ak ich výrobca nepoužil (či použil len sčasti).
- Who decides
- notified body, national market surveillance authority
- Where to look
- Directive 2009/48/EC (EUR-Lex) · Commission — Toys sector · NANDO — official database of notified bodies
Recreational Craft Directive
The question we do not answerIs this craft (or its component) in scope, and which design category and conformity module apply?Spadá toto plavidlo (alebo jeho komponent) do rozsahu a ktorá konštrukčná kategória a modul posudzovania sa uplatnia?
- When a third party is involved
- Notified-body involvement depends on the design category and the conformity module chosen; post-construction assessment always involves a notified body.Vstup notifikovanej osoby závisí od konštrukčnej kategórie a zvoleného modulu posudzovania; pri posudzovaní po výrobe vstupuje vždy.
- Who decides
- notified body, national market surveillance authority
- Where to look
- Directive 2013/53/EU (EUR-Lex) · Commission — Maritime industries · NANDO — official database of notified bodies
Lifts Directive
The question we do not answerIs this a lift or a safety component for a lift within the meaning of the Directive?Ide o výťah alebo bezpečnostný komponent výťahu v zmysle smernice?
- When a third party is involved
- Every conformity assessment route under this Directive involves a notified body, for both lifts and their safety components.Každá cesta posudzovania zhody podľa tejto smernice zahŕňa notifikovanú osobu, a to pri výťahoch aj pri ich bezpečnostných komponentoch.
- Who decides
- notified body, national market surveillance authority
- Where to look
- Directive 2014/33/EU (EUR-Lex) · Commission — Lifts sector · NANDO — official database of notified bodies
ATEX
The question we do not answerDoes this equipment fall under ATEX, and in which equipment group and category?Spadá toto zariadenie pod ATEX a do ktorej skupiny a kategórie?
- When a third party is involved
- Notified-body involvement depends on the equipment group and category (the highest categories require it; the lowest may be self-assessed).Vstup notifikovanej osoby závisí od skupiny a kategórie zariadenia (najvyššie kategórie ju vyžadujú, najnižšie si výrobca posúdi sám).
- Who decides
- notified body, national market surveillance authority
- Where to look
- Directive 2014/34/EU (EUR-Lex) · Commission — ATEX · NANDO — official database of notified bodies
RED
The question we do not answerIs this radio equipment in scope, and were the harmonised standards applied in full?Spadá toto rádiové zariadenie do rozsahu a boli harmonizované normy použité v plnom rozsahu?
- When a third party is involved
- A notified body is required where the harmonised standards were not applied, or applied only in part.Notifikovaná osoba sa vyžaduje, ak harmonizované normy neboli použité alebo boli použité len čiastočne.
- Who decides
- notified body, national market surveillance authority
- Where to look
- Directive 2014/53/EU (EUR-Lex) · Commission — Radio Equipment Directive · NANDO — official database of notified bodies
PED
The question we do not answerIs this pressure equipment in scope, and in which hazard category?Spadá toto tlakové zariadenie do rozsahu a do ktorej kategórie nebezpečnosti?
- When a third party is involved
- Notified-body involvement depends on the hazard category derived from fluid, pressure and volume; the lowest category is self-assessed.Vstup notifikovanej osoby závisí od kategórie nebezpečnosti odvodenej od média, tlaku a objemu; najnižšiu kategóriu si výrobca posúdi sám.
- Who decides
- notified body, national market surveillance authority
- Where to look
- Directive 2014/68/EU (EUR-Lex) · Commission — Pressure equipment and gas appliances · NANDO — official database of notified bodies
Cableways
The question we do not answerIs this a subsystem or safety component of a cableway installation within the meaning of the Regulation?Ide o čiastkový systém alebo bezpečnostný komponent lanovkovej inštalácie v zmysle nariadenia?
- When a third party is involved
- Subsystems and safety components are assessed with a notified body.Čiastkové systémy a bezpečnostné komponenty sa posudzujú s notifikovanou osobou.
- Who decides
- notified body, national market surveillance authority
- Where to look
- Regulation (EU) 2016/424 (EUR-Lex) · Commission — Cableways · NANDO — official database of notified bodies
PPE
The question we do not answerIs this PPE in scope, and in which risk category?Spadá tento ochranný prostriedok do rozsahu a do ktorej rizikovej kategórie?
- When a third party is involved
- Notified-body involvement depends on the risk category the PPE falls in; the lowest category is self-certified by the manufacturer.Vstup notifikovanej osoby závisí od rizikovej kategórie prostriedku; najnižšiu kategóriu si výrobca certifikuje sám.
- Who decides
- notified body, national market surveillance authority
- Where to look
- Regulation (EU) 2016/425 (EUR-Lex) · Commission — Personal protective equipment · NANDO — official database of notified bodies
Gas Appliances
The question we do not answerIs this an appliance or fitting burning gaseous fuels within the meaning of the Regulation?Ide o spotrebič alebo armatúru spaľujúcu plynné palivá v zmysle nariadenia?
- When a third party is involved
- Appliances and fittings in scope are assessed with a notified body (EU type-examination and a production-phase module).Spotrebiče a armatúry v rozsahu sa posudzujú s notifikovanou osobou (skúška typu EÚ a modul pre výrobnú fázu).
- Who decides
- notified body, national market surveillance authority
- Where to look
- Regulation (EU) 2016/426 (EUR-Lex) · Commission — Pressure equipment and gas appliances · NANDO — official database of notified bodies
MDR
The question we do not answerIs this software a medical device (MDSW) under Regulation (EU) 2017/745 given its declared intended purpose, and in which class does it fall?Je tento softvér zdravotníckou pomôckou (MDSW) podľa nariadenia (EÚ) 2017/745 vzhľadom na deklarovaný účel určenia, a do ktorej triedy patrí?
- When a third party is involved
- Notified-body involvement depends on the device class: the lowest class is self-certified by the manufacturer, higher classes are not. Software is classified under the Regulation's own rules.Vstup notifikovanej osoby závisí od triedy pomôcky: najnižšiu triedu si výrobca certifikuje sám, vyššie nie. Softvér sa klasifikuje podľa vlastných pravidiel nariadenia.
- Who decides
- notified body, national competent authority for medical devices, regulatory affairs / MDR consultant
- Note
- The declared intended purpose drives this answer — write it down before seeking an opinion. COM(2025) 1023 (16 Dec 2025) proposes moving MDR/IVDR from Annex I Section A to Section B, which would remove Chapter III via Art 2(2); it is a separate pending proposal, not part of the adopted Omnibus (see check_deadlines: mdr_ivdr_annex_shift).Odpoveď stojí na deklarovanom účele určenia — napíš ho skôr, než si vypýtaš stanovisko. COM(2025) 1023 (16. 12. 2025) navrhuje presun MDR/IVDR z prílohy I sekcie A do sekcie B, čo by cez čl. 2 ods. 2 odstránilo kapitolu III; je to samostatný návrh, nie súčasť schváleného Omnibusu (pozri check_deadlines: mdr_ivdr_annex_shift).
- Where to look
- Regulation (EU) 2017/745 — MDR (EUR-Lex) · MDCG endorsed documents and other guidance (incl. MDCG 2019-11 on qualification and classification of software) (link not machine-verified) · NANDO — official database of notified bodies
IVDR
The question we do not answerIs this software an in vitro diagnostic medical device under Regulation (EU) 2017/746, and in which class?Je tento softvér diagnostickou zdravotníckou pomôckou in vitro podľa nariadenia (EÚ) 2017/746 a do ktorej triedy patrí?
- When a third party is involved
- Notified-body involvement depends on the device class; the lowest class is self-certified where it is neither sterile nor a measuring device.Vstup notifikovanej osoby závisí od triedy pomôcky; najnižšiu triedu si výrobca certifikuje sám, ak nie je sterilná ani meracia.
- Who decides
- notified body, national competent authority for medical devices, regulatory affairs / IVDR consultant
- Note
- Same COM(2025) 1023 proposal as MDR — see check_deadlines: mdr_ivdr_annex_shift.Rovnaký návrh COM(2025) 1023 ako pri MDR — pozri check_deadlines: mdr_ivdr_annex_shift.
- Where to look
- Regulation (EU) 2017/746 — IVDR (EUR-Lex) · MDCG endorsed documents and other guidance (link not machine-verified) · NANDO — official database of notified bodies
Annex I Section B. Art 2(2) as amended by the Omnibus: for AI systems classified as high-risk under Art 6(1) that relate to products covered by a Section B act, ONLY Art 6(1), Art 60a and Arts 102 to 112 apply — Chapter III does NOT. Arts 57, 58 and 59 (regulatory sandboxes) apply in addition, but only in so far as this Regulation's high-risk requirements have been integrated into that Union harmonisation legislation. The AI Act's requirements otherwise reach this sector through the amending article listed below, which obliges the Commission to take them into account when adopting delegated or implementing acts under the sectoral regime.Príloha I sekcia B. Čl. 2 ods. 2 v znení Omnibusu: pri systémoch AI, ktoré sú vysokorizikové podľa čl. 6 ods. 1 a týkajú sa produktov podľa predpisu zo sekcie B, sa uplatnia LEN čl. 6 ods. 1, čl. 60a a čl. 102 až 112 — kapitola III NIE. Čl. 57, 58 a 59 (regulačné sandboxy) sa uplatnia navyše, ale len v rozsahu, v akom boli požiadavky tohto nariadenia na vysokorizikové systémy začlenené do daného harmonizačného predpisu Únie. Požiadavky AI Actu sa do tohto sektora inak dostávajú cez novelizačný článok uvedený nižšie, ktorý Komisii ukladá zohľadniť ich pri prijímaní delegovaných a vykonávacích aktov podľa sektorového režimu.
Aviation security
The question we do not answerDoes this system fall under the civil aviation security regime, and which implementing act governs it?Spadá tento systém pod režim bezpečnostnej ochrany civilného letectva a ktorý vykonávací akt ho upravuje?
- When a third party is involved
- Conformity is handled through the aviation-security regime and its implementing acts rather than through a notified-body module.Zhoda sa rieši režimom bezpečnostnej ochrany letectva a jeho vykonávacími aktmi, nie modulom s notifikovanou osobou.
- Who decides
- national civil aviation authority, European Commission (DG MOVE)
- AI Act reaches this sector through
- Art 102
- Where to look
- Regulation (EC) No 300/2008 (EUR-Lex) · Commission — Aviation security
L-category vehicles
The question we do not answerIs this system part of a vehicle subject to EU type-approval under this Regulation?Je tento systém súčasťou vozidla podliehajúceho typovému schváleniu EÚ podľa tohto nariadenia?
- When a third party is involved
- Conformity runs through EU type-approval by an approval authority with technical services, not through a notified-body module.Zhoda ide cez typové schválenie EÚ schvaľovacím orgánom s technickými službami, nie cez modul s notifikovanou osobou.
- Who decides
- national type-approval authority, technical service
- AI Act reaches this sector through
- Art 104
- Where to look
- Regulation (EU) No 168/2013 (EUR-Lex) · Commission — Automotive industry
Agricultural vehicles
The question we do not answerIs this system part of a vehicle subject to EU type-approval under this Regulation?Je tento systém súčasťou vozidla podliehajúceho typovému schváleniu EÚ podľa tohto nariadenia?
- When a third party is involved
- Conformity runs through EU type-approval by an approval authority with technical services.Zhoda ide cez typové schválenie EÚ schvaľovacím orgánom s technickými službami.
- Who decides
- national type-approval authority, technical service
- AI Act reaches this sector through
- Art 103
- Where to look
- Regulation (EU) No 167/2013 (EUR-Lex) · Commission — Automotive industry
Marine equipment
The question we do not answerIs this equipment listed as marine equipment subject to the wheel-mark regime?Je toto vybavenie uvedené ako námorné vybavenie podliehajúce režimu značky kormidlového kolesa?
- When a third party is involved
- Conformity runs through the wheel-mark regime, assessed by notified bodies against international instruments.Zhoda ide cez režim značky kormidlového kolesa, ktorý posudzujú notifikované osoby voči medzinárodným nástrojom.
- Who decides
- notified body, flag State administration
- AI Act reaches this sector through
- Art 105
- Where to look
- Directive 2014/90/EU (EUR-Lex) · Commission — Maritime industries · NANDO — official database of notified bodies
Rail interoperability
The question we do not answerIs this an interoperability constituent or part of a subsystem under the applicable TSI?Ide o komponent interoperability alebo časť subsystému podľa príslušnej TSI?
- When a third party is involved
- Interoperability constituents and subsystems are verified by notified bodies against the technical specifications for interoperability (TSIs); vehicle authorisation is issued by ERA or a national safety authority.Komponenty interoperability a subsystémy overujú notifikované osoby voči technickým špecifikáciám interoperability (TSI); povolenie vozidla vydáva ERA alebo národný bezpečnostný orgán.
- Who decides
- European Union Agency for Railways (ERA), national safety authority, notified body
- AI Act reaches this sector through
- Art 106
- Where to look
- Directive (EU) 2016/797 (EUR-Lex) · European Union Agency for Railways · NANDO — official database of notified bodies
Vehicle type-approval
The question we do not answerIs this system a vehicle system, component or separate technical unit subject to EU type-approval?Je tento systém systémom vozidla, komponentom alebo samostatnou technickou jednotkou podliehajúcou typovému schváleniu EÚ?
- When a third party is involved
- Conformity runs through EU type-approval by an approval authority with technical services, not through a notified-body module.Zhoda ide cez typové schválenie EÚ schvaľovacím orgánom s technickými službami, nie cez modul s notifikovanou osobou.
- Who decides
- national type-approval authority, technical service
- AI Act reaches this sector through
- Art 107
- Where to look
- Regulation (EU) 2018/858 (EUR-Lex) · Commission — Automotive industry
General Safety Regulation
The question we do not answerIs this system one of the advanced safety systems required by this Regulation?Je tento systém niektorým z pokročilých bezpečnostných systémov vyžadovaných týmto nariadením?
- When a third party is involved
- Conformity runs through EU type-approval; this Regulation sets the mandatory advanced safety systems that approval must cover.Zhoda ide cez typové schválenie EÚ; toto nariadenie určuje povinné pokročilé bezpečnostné systémy, ktoré schválenie musí pokryť.
- Who decides
- national type-approval authority, technical service
- AI Act reaches this sector through
- Art 109
- Where to look
- Regulation (EU) 2019/2144 (EUR-Lex) · Commission — Automotive industry
EASA
The question we do not answerDoes this system require EASA certification or fall under an EASA implementing rule (including the UAS rules)?Vyžaduje tento systém certifikáciu EASA alebo spadá pod vykonávací predpis EASA (vrátane pravidiel pre bezpilotné systémy)?
- When a third party is involved
- Conformity runs through EASA certification, design/production organisation approvals and the implementing rules, not through a notified-body module.Zhoda ide cez certifikáciu EASA, schválenia projekčných/výrobných organizácií a vykonávacie predpisy, nie cez modul s notifikovanou osobou.
- Who decides
- European Union Aviation Safety Agency (EASA), national aviation authority
- AI Act reaches this sector through
- Art 108
- Where to look
- Regulation (EU) 2018/1139 (EUR-Lex) · European Union Aviation Safety Agency
Machinery Regulation
The question we do not answerDoes this product fall under Regulation (EU) 2023/1230 (as machinery, a related product or a safety component), and in which conformity assessment category?Spadá tento produkt pod nariadenie (EÚ) 2023/1230 (ako strojové zariadenie, súvisiaci výrobok alebo bezpečnostný komponent) a do ktorej kategórie posudzovania zhody?
- When a third party is involved
- Conformity runs through the machinery regime: a notified body is involved only for the categories listed in Annex I Part A of that Regulation, and otherwise the manufacturer assesses conformity itself.Zhoda ide režimom strojových zariadení: notifikovaná osoba vstupuje len pri kategóriách uvedených v prílohe I časti A tohto nariadenia, inak posudzuje zhodu výrobca sám.
- Who decides
- notified body, national market surveillance authority, the manufacturer's own conformity assessment where permitted
- AI Act reaches this sector through
- omni:Art 3
- Note
- Until 26 July 2026 machinery sat in Annex I Section A point 1, citing the now-repealed Directive 2006/42/EC, so the full Chapter III regime applied. The Omnibus moved it to Section B point 21 and pointed it at Regulation (EU) 2023/1230; the AI Act's requirements now reach machinery through delegated acts under Article 8 of that Regulation, which apply by 2 August 2028. Answers about earlier dates follow the old route.Do 26. 7. 2026 boli strojové zariadenia v prílohe I sekcii A bode 1 s odkazom na už zrušenú smernicu 2006/42/ES, takže platil celý režim kapitoly III. Omnibus ich presunul do sekcie B bodu 21 a naviazal na nariadenie (EÚ) 2023/1230; požiadavky AI Actu sa k strojovým zariadeniam dostávajú cez delegované akty podľa článku 8 tohto nariadenia, ktoré sa uplatnia do 2. 8. 2028. Pre skoršie dátumy platí pôvodná cesta.
- Where to look
- Regulation (EU) 2023/1230 — Machinery Regulation (EUR-Lex) · Regulation (EU) 2026/1744 — Digital Omnibus on AI (EUR-Lex) · Commission — Machinery sector · NANDO — official database of notified bodies
Pointers verified 2026-07-22. The corpus watcher tracks the AI Act only — sectoral acts and their guidance change without notice here.Ukazovatele overené 2026-07-22. Watcher sleduje len AI Act — sektorové predpisy a ich usmernenia sa menia bez toho, aby sa to sem premietlo.