CRA; I–VIII lisa

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.

tootja nimi, registreeritud kaubanimi või registreeritud kaubamärk ning postiaadress, e-posti aadress või muud digitaalsed kontaktandmed, ja kui see on olemas, veebisait, mille kaudu saab tootjaga ühendust võtta;

ühtne kontaktpunkt, kuhu võib saata ja kus võetakse vastu teavet digielemente sisaldava toote nõrkuste kohta ning kust võib leida tootja nõrkuste koordineeritud avalikustamise põhimõtted;

nimi ja tüüp ning mis tahes lisateave, mille põhjal saab digielemente sisaldava toote kordumatult tuvastada;

digielemente sisaldava toote sihtotstarve, sh tootja poolt ette nähtud turvakeskkond, ning toote olulised funktsioonid ja teave turvaomaduste kohta;

kõik teadaolevad või prognoositavad asjaolud, mis on seotud digielemente sisaldava toote kasutamisega vastavalt selle sihtotstarbele või mõistlikult prognoositava väärkasutamise tingimustes, mis võivad põhjustada olulisi küberriske;

kui see on asjakohane, siis internetiaadress, kus saab juurde pääseda ELi vastavusdeklaratsioonile;

see, millist liiki tehnilist turvatuge tootja pakub, ja toe kestuse, mille jooksul võivad kasutajad eeldada, et nõrkustega tegeletakse ja neile pakutakse turvauuendusi, lõppkuupäev;

üksikasjalikud juhised või internetiaadress, mis viitab sellistele üksikasjalikele juhistele ja teabele selle kohta:

millised on vajalikud meetmed toote esmasel kasutuselevõtmisel ja toote kasutusea jooksul, et tagada digielemente sisaldava toote turvaline kasutamine;

kuidas digielemente sisaldava toote muutmine võib mõjutada andmete turvalisust;

kuidas saab paigaldada turvalisuse seisukohast olulisi uuendusi;

kuidas digielemente sisaldav toode turvaliselt kasutusest kõrvaldada, sh teave selle kohta, kuidas kasutaja andmed turvaliselt eemaldada;

kuidas saab I lisa I osa punktis c nõutud turvauuenduste automaatset paigaldamist võimaldava vaikesätte välja lülitada;

kui digielemente sisaldav toode on ette nähtud integreerimiseks muudesse digielemente sisaldavatesse toodetesse, siis teave, mis on vajalik integreerija jaoks, et järgida I lisas sätestatud olulisi küberturvalisuse nõudeid ja VII lisas sätestatud dokumenteerimisnõudeid;

kui tootja otsustab teha tarkvara koostenimekirja kasutajale kättesaadavaks, siis teave selle kohta, kust on võimalik tarkvara koostenimekirjale juurde pääseda.

Identiteedihalduse süsteemide ja eelisjuurdepääsu haldamise tarkvara ja riistvara, sh autentimis- ja juurdepääsu kontrolli lugerid, kaasa arvatud biomeetriliste andmete lugerid

Autonoomsed ja sisseehitatud veebibrauserid

Paroolihaldurid

Tarkvara, mis otsib pahavara, kõrvaldab selle või paneb karantiini

Digielemente sisaldavad tooted, millel on virtuaalse privaatvõrgu (VPN) funktsioon

Võrguhalduse süsteemid

Turvateabe ja -sündmuste haldamise (SIEM) süsteemid

Buutimishaldurid

Avaliku võtme taristu ja digisertifikaatide väljaandmise tarkvara

Füüsilised ja virtuaalsed võrguliidesed

Operatsioonisüsteemid

Ruuterid, internetiühenduse jaoks mõeldud modemid ja kommutaatorid

Turvafunktsioonidega mikroprotsessorid

Turvafunktsioonidega mikrokontrollerid

Turvafunktsioonidega rakendusspetsiifilised integraallülitused (ASIC) ja programmeeritavad ventiilimaatriksid (FPGA)

Nutikodu üldotstarbelised virtuaalassistendid

Turvafunktsioonidega nutikodu tooted, sh arukad ukselukud, turvakaamerad, beebimonitorisüsteemid ja häiresüsteemid

Euroopa Parlamendi ja nõukogu direktiiviga 2009/48/EÜ (1) hõlmatud internetiühendusega mänguasjad, millel on interaktiivsed sotsiaalfunktsioonid (nt rääkimine või filmimine) või millel on asukoha jälgimise funktsioonid

Inimkehal kantavad või inimkehale paigutatavad isiklikud kantavad tooted, millel on terviseseire (nt jälgimise) eesmärk ja mille suhtes ei kohaldata määrust (EL) 2017/745 või määrust (EL) 2017/746, või isiklikud kantavad tooted, mis on ette nähtud kasutamiseks laste poolt ja lastel

Hüperviisorid ja konteinerite käigusüsteemid, mis toetavad operatsioonisüsteemide ja samalaadsete keskkondade virtualiseeritud käitamist

Tulemüürid, sissetungi tuvastamise ja ennetamise süsteemid

Muukimiskindlad mikroprotsessorid

Muukimiskindlad mikrokontrollerid

Nimi ja tüüp ning mis tahes lisateave, mille põhjal saab digielemente sisaldava toote kordumatult tuvastada

Tootja või tema volitatud esindaja nimi ja aadress

Märge, et ELi vastavusdeklaratsioon on väljastatud üksnes pakkuja vastutusel

Deklareeritav toode (digielemente sisaldava toote identifitseerimine, mis võimaldab toodet jälgida, millega võib olla kaasas ka foto, kui see on asjakohane)

Kinnitus, et eelkirjeldatud deklareeritav toode on kooskõlas asjaomaste liidu ühtlustamisõigusaktidega

Viited kasutatud asjaomastele harmoneeritud standarditele või muule ühtsele spetsifikatsioonile või küberturvalisuse sertifitseerimisele, millele vastavust deklareeritakse

Kui see on asjakohane, siis teada antud asutuse nimi ja number, vastavushindamismenetluse kirjeldus ja väljastatud sertifikaadi tunnusnumber

Lisateave:

digielemente sisaldava toote üldine kirjeldus, sealhulgas:

selle sihtotstarve;

tarkvara versioonid, mis mõjutavad seadme vastavust olulistele küberturvalisuse nõuetele;

kui digielemente sisaldav toode on riistvaratoode, siis fotod või illustratsioonid, mis kujutavad toote väliseid tunnuseid, märgistust ja sisemist struktuuri;

II lisas sätestatud kasutajatele mõeldud teave ja juhised;

digielemente sisaldava toote projekteerimise, arendamise ja tootmise ning nõrkuste käsitlemise protsesside kirjeldus, sealhulgas:

vajalik teave digielemente sisaldava toote projekteerimise ja arendamise kohta, sh, kui see on asjakohane, joonised ja skeemid ja süsteemi arhitektuuri kirjeldus, mis selgitavad, kuidas tarkvarakomponendid üksteisele tuginevad või üksteisele sisendit annavad ja kuidas need on üldisesse töötlemisse integreeritud;

vajalik teave ja spetsifikatsioonid tootja kehtestatud nõrkuste käsitlemise protsesside kohta, sh tarkvara koostenimekiri, nõrkuste koordineeritud avalikustamise põhimõtted, tõendid selle kohta, et on esitatud kontaktaadress, millele nõrkustest teatada, ja uuenduste turvaliseks levitamiseks valitud tehniliste lahenduste kirjeldus;

vajalik teave ja spetsifikatsioonid digielemente sisaldava toote tootmise ja seire protsesside ning nende protsesside valideerimise kohta;

käesoleva määruse artikli 13 kohane hinnang küberriskidele, mille tõrjumiseks digielemente sisaldav toode on projekteeritud, arendatud, toodetud, tarnitud ja hooldatud, nagu on sätestatud artiklis 13, sealhulgas see, kuidas on kohaldatavad I lisa I osas sätestatud olulised küberturvalisuse nõuded;

asjakohane teave, mida võeti artikli 13 lõike 8 kohaselt arvesse digielemente sisaldava toote toe kestuse kindlaksmääramisel;

loetelu täielikult või osaliselt kohaldatavatest harmoneeritud standarditest, mille viitenumbrid on avaldatud Euroopa Liidu Teatajas, käesoleva määruse artiklis 27 sätestatud ühtsetest spetsifikatsioonidest või määruse (EL) 2019/881 kohaselt vastu võetud Euroopa küberturvalisuse sertifitseerimise kavadest vastavalt käesoleva määruse artikli 27 lõikele 8, ning kui kõnealuseid harmoneeritud standardeid, ühtseid spetsifikatsioone või Euroopa küberturvalisuse sertifitseerimise kavasid ei ole kohaldatud, siis nende lahenduste kirjeldused, mis on vastu võetud, et järgida I lisa I ja II osas sätestatud olulisi küberturvalisuse nõudeid, sealhulgas muude kohaldatud asjakohaste tehniliste spetsifikatsioonide loetelu. Osaliselt kohaldatud harmoneeritud standardite, ühtsete spetsifikatsioonide või Euroopa küberturvalisuse sertifitseerimise kavade puhul täpsustatakse tehnilises dokumentatsioonis osad, mida on kohaldatud;

aruanded testide kohta, mis on tehtud, et kontrollida digielemente sisaldava toote ja nõrkuste käsitlemise protsesside vastavust I lisa I ja II osas sätestatud kohaldatavatele olulistele küberturvalisuse nõuetele;

ELi vastavusdeklaratsiooni koopia;

kui see on asjakohane, tarkvara koostenimekiri turujärelevalveasutuse põhjendatud taotluse korral, kui see on vajalik, et kõnealune asutus saaks kontrollida vastavust I lisas sätestatud olulistele küberturvalisuse nõuetele.

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

Volitatud esindajad

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