CRA; prilozi I.–VIII.

Products with digital elements shall be designed, developed and produced in such a way that they ensure an appropriate level of cybersecurity based on the risks.

On the basis of the cybersecurity risk assessment referred to in Article 13(2) and where applicable, products with digital elements shall:

be made available on the market without known exploitable vulnerabilities;

be made available on the market with a secure by default configuration, unless otherwise agreed between manufacturer and business user in relation to a tailor-made product with digital elements, including the possibility to reset the product to its original state;

ensure that vulnerabilities can be addressed through security updates, including, where applicable, through automatic security updates that are installed within an appropriate timeframe enabled as a default setting, with a clear and easy-to-use opt-out mechanism, through the notification of available updates to users, and the option to temporarily postpone them;

ensure protection from unauthorised access by appropriate control mechanisms, including but not limited to authentication, identity or access management systems, and report on possible unauthorised access;

protect the confidentiality of stored, transmitted or otherwise processed data, personal or other, such as by encrypting relevant data at rest or in transit by state of the art mechanisms, and by using other technical means;

protect the integrity of stored, transmitted or otherwise processed data, personal or other, commands, programs and configuration against any manipulation or modification not authorised by the user, and report on corruptions;

process only data, personal or other, that are adequate, relevant and limited to what is necessary in relation to the intended purpose of the product with digital elements (data minimisation);

protect the availability of essential and basic functions, also after an incident, including through resilience and mitigation measures against denial-of-service attacks;

minimise the negative impact by the products themselves or connected devices on the availability of services provided by other devices or networks;

be designed, developed and produced to limit attack surfaces, including external interfaces;

be designed, developed and produced to reduce the impact of an incident using appropriate exploitation mitigation mechanisms and techniques;

provide security related information by recording and monitoring relevant internal activity, including the access to or modification of data, services or functions, with an opt-out mechanism for the user;

provide the possibility for users to securely and easily remove on a permanent basis all data and settings and, where such data can be transferred to other products or systems, ensure that this is done in a secure manner.

identify and document vulnerabilities and components contained in products with digital elements, including by drawing up a software bill of materials in a commonly used and machine-readable format covering at the very least the top-level dependencies of the products;

in relation to the risks posed to products with digital elements, address and remediate vulnerabilities without delay, including by providing security updates; where technically feasible, new security updates shall be provided separately from functionality updates;

apply effective and regular tests and reviews of the security of the product with digital elements;

once a security update has been made available, share and publicly disclose information about fixed vulnerabilities, including a description of the vulnerabilities, information allowing users to identify the product with digital elements affected, the impacts of the vulnerabilities, their severity and clear and accessible information helping users to remediate the vulnerabilities; in duly justified cases, where manufacturers consider the security risks of publication to outweigh the security benefits, they may delay making public information regarding a fixed vulnerability until after users have been given the possibility to apply the relevant patch;

put in place and enforce a policy on coordinated vulnerability disclosure;

take measures to facilitate the sharing of information about potential vulnerabilities in their product with digital elements as well as in third-party components contained in that product, including by providing a contact address for the reporting of the vulnerabilities discovered in the product with digital elements;

provide for mechanisms to securely distribute updates for products with digital elements to ensure that vulnerabilities are fixed or mitigated in a timely manner and, where applicable for security updates, in an automatic manner;

ensure that, where security updates are available to address identified security issues, they are disseminated without delay and, unless otherwise agreed between a manufacturer and a business user in relation to a tailor-made product with digital elements, free of charge, accompanied by advisory messages providing users with the relevant information, including on potential action to be taken.

ime, registrirano trgovačko ime ili registrirani žig proizvođača, poštanska adresa, e-adresa ili drugi digitalni kontakt te, ako je dostupna, internetska stranica na kojoj se može stupiti u kontakt s proizvođačem;

jedinstvena kontaktna točka gdje se mogu dojaviti i dobiti informacije o ranjivostima proizvoda s digitalnim elementima te pronaći politika proizvođača u vezi s koordiniranim otkrivanjem ranjivosti;

naziv i vrsta proizvoda s digitalnim elementima te svi dodatni podaci na temelju kojih ga je moguće jedinstveno identificirati;

namjena proizvoda s digitalnim elementima, uključujući sigurnosno okruženje kako ga je uspostavio proizvođač, te bitne funkcionalnosti proizvoda i informacije o sigurnosnim svojstvima;

sve poznate i predvidljive okolnosti povezane s upotrebom proizvoda s digitalnim elementima u skladu s njegovom namjenom ili u uvjetima razumno predvidljive krive upotrebe zbog kojih mogu nastati znatni kibernetički sigurnosni rizici;

ako je primjenjivo, internetska adresa na kojoj se može pristupiti EU izjavi o sukladnosti;

vrsta tehničke sigurnosne podrške koju nudi proizvođač i datum završetka razdoblja potpore tijekom kojeg korisnici mogu očekivati postupanje s ranjivostima i sigurnosna ažuriranja;

detaljne upute ili internetska adresa za takve detaljne upute i informacije o:

potrebnim mjerama za sigurnu upotrebu proizvoda s digitalnim elementima tijekom njegova stavljanja u upotrebu i cijelog životnog vijeka;

mogućem utjecaju promjena proizvoda s digitalnim elementima na sigurnost podataka;

načinu instaliranja ažuriranja važnih za sigurnost;

sigurnom stavljanju proizvoda s digitalnim elementima izvan upotrebe, uključujući informacije o sigurnom uklanjanju korisničkih podataka;

pitanju kako se može isključiti zadana postavka koja omogućuje automatsku ugradnju sigurnosnih ažuriranja, kako se zahtijeva u dijelu I. točki 2. podtočki (c) Priloga I.;

ako je proizvod s digitalnim elementima namijenjen za integraciju u druge proizvode s digitalnim elementima, informacije potrebne kako bi se integrator uskladio s bitnim zahtjevima u pogledu kibernetičke sigurnosti utvrđenima u Prilogu I. i zahtjevima u pogledu dokumentacije utvrđenima u Prilogu VII.

Ako proizvođač odluči korisniku staviti na raspolaganje popis softverskog materijala, informacije o tome gdje se može pristupiti popisu softverskog materijala.

Sustavi za upravljanje identitetom te softver i hardver za upravljanje povlaštenim pristupom, uključujući čitače za provjeru autentičnosti i kontrolu pristupa, uključujući biometrijske čitače

Samostalni i ugrađeni preglednici

Upravitelji lozinki

Softver za traženje, uklanjanje ili izoliranje zlonamjernog softvera

Proizvodi s digitalnim elementima s funkcijom virtualne privatne mreže (VPN)

Sustavi za upravljanje mrežom

Sustavi za upravljanje sigurnosnim informacijama i događajima (SIEM)

Upravitelji pokretanja sustava

Infrastruktura javnih ključeva i softver za izdavanje digitalnih certifikata

Fizička i virtualna mrežna sučelja

Operativni sustavi

Ruteri, modemi namijenjeni za spajanje na internet i preklopnici

Mikroprocesori s funkcijama povezanima sa sigurnošću

Mikrokontroleri s funkcijama povezanima sa sigurnošću

Integrirani krugovi specijalizirane namjene (ASIC) i programirljivi logički sklopovi (FPGA) s funkcijama povezanima sa sigurnošću

Virtualni asistenti opće namjene za pametne kuće

Proizvodi za pametne kuće sa sigurnosnim funkcijama, uključujući pametne brave za vrata, sigurnosne kamere, sustave za nadzor male djece i alarmne sustave

Igračke povezane s internetom obuhvaćene Direktivom 2009/48/EZ Europskog parlamenta i Vijeća (1) koje imaju društvene interaktivne značajke (npr. govor ili snimanje) ili imaju značajke praćenja lokacije

Osobni nosivi proizvodi koje treba nositi ili staviti na ljudsko tijelo i koji imaju svrhu praćenja zdravlja (kao što je praćenje) i na koje se ne primjenjuju Uredba (EU) 2017/745 ili Uredba (EU) 2017/746 ili osobni nosivi proizvodi koji su namijenjeni za upotrebu od strane djece ili za djecu

Hipervizori i sustavi za izolirano izvršavanje koji omogućuju virtualizirano izvršavanje operativnih sustava i slična okruženja

Vatrozidovi, sustavi za otkrivanje i sprečavanje neovlaštenih upada

Mikroprocesori otporni na manipuliranje

Mikrokontroleri otporni na manipuliranje

naziv i vrstu proizvoda s digitalnim elementima te sve dodatne podatke na temelju kojih ga je moguće jedinstveno identificirati

ime i adresu proizvođača ili njegova ovlaštenog zastupnika

izjavu da je za izdavanje EU izjave o sukladnosti odgovoran isključivo dobavljač

predmet izjave (identifikacijski podaci proizvoda s digitalnim elementima koji omogućuju sljedivost, što prema potrebi može uključivati fotografiju)

izjavu da je opisani predmet izjave sukladan s relevantnim zakonodavstvom Unije o usklađivanju

upućivanje na sve relevantne primijenjene usklađene norme ili bilo koju drugu zajedničku specifikaciju ili kibernetičku sigurnosnu certifikaciju na temelju koje se izjavljuje sukladnost

ako je primjenjivo, ime i identifikacijski broj prijavljenog tijela, opis provedenog postupka ocjenjivanja sukladnosti te identifikacijsku oznaku izdane potvrde

dodatne informacije:

opći opis proizvoda s digitalnim elementima, uključujući:

njegovu namjenu;

verzije softvera koje utječu na sukladnost s bitnim zahtjevima u pogledu kibernetičke sigurnosti;

ako je proizvod s digitalnim elementima hardverski proizvod, fotografije ili ilustracije koje prikazuju vanjska obilježja, oznake i unutarnji raspored;

informacije i upute za korisnike kako su utvrđene u Prilogu II.;

opis projektiranja, razvoja i proizvodnje proizvoda s digitalnim elementima te procese postupanja s ranjivostima, uključujući:

potrebne informacije o projektiranju i razvoju proizvoda s digitalnim elementima, uključujući, ako je primjenjivo, crteže i sheme i/ili opis arhitekture sustava iz kojih se vidjeti međuovisnost ili odnos softverskih komponenti i kako su integrirane u cjelokupnu obradu;

potrebne informacije i specifikacije procesa postupanja s ranjivostima koje je uveo proizvođač, uključujući popis softverskog materijala, politiku koordiniranog otkrivanja ranjivosti, dokaz o uspostavljanju adrese za kontakt za prijavljivanje ranjivosti te opis tehničkih rješenja odabranih za sigurnu distribuciju ažuriranja;

potrebne informacije i specifikacije koje se odnose na procese proizvodnje i praćenja proizvoda s digitalnim elementima i validaciju tih procesa;

procjenu kibernetičkih sigurnosnih rizika koji su uzeti u obzir pri projektiranju, razvoju, proizvodnji, isporuci i održavanju proizvoda s digitalnim elementima u skladu s člankom 13., uključujući način na koji se primjenjuju bitni zahtjevi u pogledu kibernetičke sigurnosti utvrđeni u dijelu I. Priloga I.;

relevantne informacije koje su uzete u obzir pri utvrđivanju razdoblja potpore u skladu s člankom 13. stavkom 8. za proizvod s digitalnim elementima;

popis u cijelosti ili djelomično primijenjenih usklađenih normi na koje su upućivanja objavljena u Službenom listu Europske unije, zajedničkih specifikacija kako su utvrđene u članku 27. ove Uredbe ili europskih programa kibernetičke sigurnosne certifikacije donesenih u skladu s Uredbom (EU) 2019/881 u skladu s člankom 27. stavkom 8. ove Uredbe, a ako te usklađene norme, zajedničke specifikacije ili europski programi kibernetičke sigurnosne certifikacije nisu primijenjene, opise rješenja koja su prihvaćena kako bi se ispunili bitni zahtjevi u pogledu kibernetičke sigurnosti utvrđeni u dijelovima I. i II. Priloga I., uključujući popis drugih primijenjenih relevantnih tehničkih specifikacija. Ako su usklađene norme, zajedničke specifikacije ili europski programi kibernetičke sigurnosne certifikacije primijenjeni djelomično, u tehničkoj dokumentaciji navode se dijelovi koji su primijenjeni;

izvješća o ispitivanjima provedenima radi provjere sukladnosti proizvoda s digitalnim elementima i procesa postupanja s ranjivostima s primjenjivim bitnim zahtjevima u pogledu kibernetičke sigurnosti utvrđenima u dijelovima I. i II. Priloga I.;

primjerak EU izjave o sukladnosti;

ako je primjenjivo, popis softverskog materijala na obrazložen zahtjev tijela za nadzor tržišta pod uvjetom da je to potrebno kako bi to tijelo moglo provjeriti usklađenost s bitnim zahtjevima u pogledu kibernetičke sigurnosti utvrđenima u Prilogu I.

Internal control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 4 of this Part, and ensures and declares on its sole responsibility that the products with digital elements satisfy all the essential cybersecurity requirements set out in Part I of Annex I and the manufacturer meets the essential cybersecurity requirements set out in Part II of Annex I.

The manufacturer shall draw up the technical documentation described in Annex VII.

Design, development, production and vulnerability handling of products with digital elements

Conformity marking and declaration of conformity

Ovlašteni zastupnici

EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design and development of a product with digital elements and the vulnerability handling processes put in place by the manufacturer, and attests that a product with digital elements meets the essential cybersecurity requirements set out in Part I of Annex I and that the manufacturer meets the essential cybersecurity requirements set out in Part II of Annex I.

EU-type examination shall be carried out by assessing the adequacy of the technical design and development of the product with digital elements through the examination of the technical documentation and supporting evidence referred to in point 3, and the examination of specimens of one or more critical parts of the product (combination of production type and design type).

The manufacturer shall lodge an application for EU-type examination with a single notified body of its choice.

The notified body shall:

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

Where the type and the vulnerability handling processes meet the essential cybersecurity requirements set out in Annex I, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type and vulnerability handling processes. The certificate may have one or more annexes attached.

The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type and the vulnerability handling processes may no longer comply with the applicable essential cybersecurity requirements set out in Annex I, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

The notified body shall carry out periodic audits to ensure that the vulnerability handling processes as set out in Part II of Annex I are implemented adequately.

Each notified body shall inform its notifying authorities concerning the EU-type examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and any additions thereto refused, suspended or otherwise restricted.

The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer.

The manufacturer’s authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 10, provided that the relevant obligations are specified in the mandate.

Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2 and 3 of this Part, and ensures and declares that the products with digital elements concerned are in conformity with the type described in the EU-type examination certificate and satisfy the essential cybersecurity requirements set out in Part I of Annex I and that the manufacturer meets the essential cybersecurity requirements set out in Part II of Annex I.

Production

Conformity marking and declaration of conformity

Authorised representative

Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2 and 5 of this Part, and ensures and declares on its sole responsibility that the products with digital elements or product categories concerned satisfy the essential cybersecurity requirements set out in Part I of Annex I and that the vulnerability handling processes put in place by the manufacturer meet the requirements set out in Part II of Annex I.

Design, development, production and vulnerability handling of products with digital elements

Quality system

the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of that authorised representative;

the technical documentation for one model of each category of products with digital elements intended to be manufactured or developed. The technical documentation shall, wherever applicable, contain at least the elements as set out in Annex VII;

the documentation concerning the quality system; and

a written declaration that the same application has not been lodged with any other notified body.

the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design, development, product quality and vulnerability handling;

the technical design and development specifications, including standards, that will be applied and, where the relevant harmonised standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential cybersecurity requirements set out in Part I of Annex I that apply to the products with digital elements will be met;

the procedural specifications, including standards, that will be applied and, where the relevant harmonised standards or technical specifications will not be applied in full, the means that will be used to ensure that the essential cybersecurity requirements set out in Part II of Annex I that apply to the manufacturer will be met;

the design and development control, as well as design and development verification techniques, processes and systematic actions that will be used when designing and developing the products with digital elements pertaining to the product category covered;

the corresponding production, quality control and quality assurance techniques, processes and systematic actions that will be used;

the examinations and tests that will be carried out before, during and after production, and the frequency with which they will be carried out;

the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned;

the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

Surveillance under the responsibility of the notified body

the quality system documentation;

the quality records as provided for by the design part of the quality system, such as results of analyses, calculations and tests;

the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.

Conformity marking and declaration of conformity

The manufacturer shall, for a period ending at least 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer, keep at the disposal of the national authorities:

the technical documentation referred to in point 3.1;

the documentation concerning the quality system referred to in point 3.1;

the change referred to in point 3.5, as approved;

the decisions and reports of the notified body referred to in points 3.5 and 4.3.

Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted.

Authorised representative