+Članak 104.
---+Article 104 (1)
---+Article 104 (2)
---+Article 104 (3)

Članak 104.

Članak 104.

Izmjena Uredbe (EU) 2024/2847

Uredba (EU) 2024/2847 mijenja se kako slijedi:

1. 

u članku 13., stavak 4. zamjenjuje se sljedećim:

„4.  
Pri stavljanju na tržište proizvoda s digitalnim elementima proizvođač u tehničku dokumentaciju koja se zahtijeva u skladu s člankom 31. i Prilogom VII. uključuje procjenu kibernetičkih sigurnosnih rizika iz stavka 3. ovoga članka. Za proizvode s digitalnim elementima iz članka 12. i članka 32. stavka 5.a koji podliježu i drugim pravnim aktima Unije procjena kibernetičkih sigurnosnih rizika može biti dio procjene rizika koja se zahtijeva tim pravnim aktima Unije. Ako određeni bitni zahtjevi u pogledu kibernetičke sigurnosti nisu primjenjivi na proizvod s digitalnim elementima, proizvođač u tu tehničku dokumentaciju uključuje jasno obrazloženje.”

;

2. 

u članku 31., stavak 3. zamjenjuje se sljedećim:

„3.  
Za proizvode s digitalnim elementima iz članka 12. i članka 32. stavka 5.a koji podliježu i drugim pravnim aktima Unije kojima se predviđa tehnička dokumentacija sastavlja se jedinstvena tehnička dokumentacija koja sadržava informacije iz Priloga VII. i informacije koje se zahtijevaju tim pravnim aktima Unije.”

;

3. 

u članku 32., umeće se sljedeći stavak:

„5.a  
Proizvođači proizvoda s digitalnim elementima koji su klasificirani kao sustavi elektroničkih zdravstvenih zapisa na temelju Uredbe (EU) 2025/327 Europskog parlamenta i Vijeća ( *1 ) sukladnost s bitnim zahtjevima utvrđenima u Prilogu I. ovoj Uredbi dokazuju primjenom odgovarajućeg postupka ocjenjivanja sukladnosti iz poglavlja III. Uredbe (EU) 2025/327.

1. Pregled

,
Article 104 (1)

in Article 13, paragraph 4 is replaced by the following:

‘4.   When placing a product with digital elements on the market, the manufacturer shall include the cybersecurity risk assessment referred to in paragraph 3 of this Article in the technical documentation required pursuant to Article 31 and Annex VII. For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts, the cybersecurity risk assessment may be part of the risk assessment required by those Union legal acts. Where certain essential cybersecurity requirements are not applicable to the product with digital elements, the manufacturer shall include a clear justification to that effect in that technical documentation.’
Article 104 (2)

in Article 31, paragraph 3 is replaced by the following:

‘3.   For products with digital elements as referred to in Article 12 and Article 32(5a), which are also subject to other Union legal acts which provide for technical documentation, a single set of technical documentation shall be drawn up containing the information referred to in Annex VII and the information required by those Union legal acts.’
Article 104 (3)

in Article 32, the following paragraph is inserted:

‘5a.   Manufacturers of products with digital elements that are classified as EHR systems under Regulation (EU) 2025/327 of the European Parliament and of the Council (*1) shall demonstrate conformity with the essential requirements set out in Annex I to this Regulation using the relevant conformity assessment procedure provided for in Chapter III of Regulation (EU) 2025/327.

(*1)  Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj).’."

1.1 Reference

1.2 Utvrđeni zahtjevi

1.3 Povezani standardi

2. Utvrđeni zahtjevi

Zahtjevi

3. Povezani standardi

Standardi
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