CRA; Priloge 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 trgovsko ime ali registrirana znamka proizvajalca, poštni naslov, elektronski naslov ali drug digitalni stik ter spletno mesto, na katerem je proizvajalec dosegljiv, kadar je na voljo;

enotna kontaktna točka, kjer je mogoče sporočiti in prejeti informacije o ranljivostih izdelka z digitalnimi elementi in kjer je mogoče najti politiko proizvajalca o usklajenem razkrivanju ranljivosti;

ime, vrsta in vse dodatne informacije, ki omogočajo edinstveno identifikacijo izdelka z digitalnimi elementi;

predvideni namen uporabe izdelka z digitalnimi elementi, vključno z varnostnim okoljem, ki ga zagotavlja proizvajalec, ter ključne funkcije in informacije o varnostnih lastnostih;

vse znane ali predvidljive okoliščine, povezane z uporabo izdelka z digitalnimi elementi v skladu z njegovim predvidenim namenom ali v razmerah razumno predvidljive napačne uporabe, ki lahko pripeljejo do povečanega tveganja za kibernetsko varnost;

kadar je ustrezno, spletni naslov, kjer je na voljo EU izjava o skladnosti;

vrsta tehnične varnostne podpore, ki jo ponuja proizvajalec, in končni datum obdobja podpore, v katerem lahko uporabniki pričakujejo odpravo ranljivosti in prejemanje varnostnih posodobitev;

podrobna navodila ali spletni naslov s takimi podrobnimi navodili in informacijami o:

potrebnih ukrepih v času začetne uporabe in v celotnem življenjskem ciklu izdelka z digitalnimi elementi, da se zagotovi njegova varna uporaba;

tem, kako lahko spremembe izdelka z digitalnimi elementi vplivajo na varnost podatkov;

nameščanju posodobitev, ki so pomembne za varnost;

varnem prenehanju uporabe izdelka z digitalnimi elementi, vključno z informacijami o varni odstranitvi podatkov o uporabniku.

kako se lahko izklopi privzeta nastavitev, ki omogoča samodejno namestitev varnostnih posodobitev, kot se zahteva v delu I, točka (c), Priloge I;

kadar je izdelek z digitalnimi elementi namenjen vgradnji v druge izdelke z digitalnimi elementi, informacije, ki jih integrator potrebuje za izpolnjevanje bistvenih zahtev glede kibernetske varnosti iz Priloge I, in zahteve glede dokumentacije iz Priloge VII.

Če se proizvajalec odloči, da bo uporabniku dal na voljo kosovnico za programsko opremo, informacije o tem, kje je mogoče dobiti dostop do te kosovnice.

Programska oprema za sisteme za upravljanje identitete ter programska in strojna oprema za upravljanje privilegiranih dostopov, vključno z bralniki za avtentikacijo uporabnika in nadzor dostopa, vključno z biometričnimi bralniki

Samostojni in vgrajeni brskalniki

Upravitelji gesel

Programska oprema, ki išče, odstranjuje ali daje v karanteno zlonamerno programsko opremo

Izdelki z digitalnimi elementi s funkcijo navideznega zasebnega omrežja (VPN)

Sistemi za upravljanje omrežja

Varnostni sistemi za upravljanje informacij in dogodkov (SIEM)

Upravitelji zagona

Infrastruktura javnih ključev in programska oprema za izdajanje digitalnih certifikatov

Fizični in navidezni omrežni vmesniki

Operacijski sistemi

Usmerjevalniki, modemi, namenjeni povezovanju z internetom, in stikala

Mikroprocesorji z varnostnimi funkcijami

Mikrokrmilniki z varnostnimi funkcijami

Integrirana vezja za določen namen (ASIC) in programljive matrike logičnih vrat (FPGA) z varnostnimi funkcijami

Splošni virtualni pomočniki za pametni dom

Izdelki za pametni dom z varnostnimi funkcijami, vključno s pametnimi ključavnicami, varnostnimi kamerami, sistemi za spremljanje dojenčkov in alarmnimi sistemi

Z internetom povezane igrače, zajete v Direktivi 2009/48/ES Evropskega parlamenta in Sveta (1), ki imajo funkcije socialne interakcije (npr. govorjenje ali snemanje) ali imajo funkcije za sledenje lokaciji

Osebni nosljivi izdelki, ki so namenjeni nošenju ali namestitvi na človeško telo za namene spremljanja zdravja (kot je sledenje) in za katere se ne uporablja Uredba (EU) 2017/745 ali (EU) 2017/746, ali osebni nosljivi izdelki, namenjeni uporabi pri otrocih in za otroke

Hipernadzorniki in izvajalni sistemi vsebnika, ki podpirajo virtualizirano delovanje operacijskih sistemov in podobnih okolij

Požarni zidovi, sistemi za zaznavanje in preprečevanje vdorov

Mikroprocesorji, zavarovani pred nepooblaščenimi posegi

Mikrokrmilniki, zavarovani pred nepooblaščenimi posegi

ime, vrsto in vse dodatne informacije, ki omogočajo edinstveno identifikacijo izdelka z digitalnimi elementi

ime in naslov proizvajalca ali njegovega pooblaščenega zastopnika

izjavo, da je za izdajo EU izjave o skladnosti odgovoren izključno proizvajalec

predmet izjave (identifikacija izdelka z digitalnimi elementi, ki omogoča sledljivost; kadar je ustrezno, se lahko priloži fotografija)

izjavo, da je predmet zgoraj navedene izjave skladen z ustrezno harmonizacijsko zakonodajo Unije

sklice na morebitne uporabljene ustrezne harmonizirane standarde ali druge skupne specifikacije ali certifikacijske sheme kibernetske varnosti, v zvezi s katerimi se zatrjuje skladnost

kadar je ustrezno, ime in številko priglašenega organa, opis opravljenega postopka ugotavljanja skladnosti in identifikacijo izdanega potrdila

dodatne informacije:

splošni opis izdelka z digitalnimi elementi, ki vključuje:

njegov predvideni namen;

različice programske opreme, ki vplivajo na skladnost z bistvenimi zahtevami glede kibernetske varnosti;

kadar je izdelek z digitalnimi elementi izdelek strojne opreme, fotografije ali ilustracije, ki prikazujejo zunanje značilnosti, oznake in notranjo razporeditev;

informacije za uporabnika in navodila, kakor so navedena v Prilogi II;

opis zasnove, razvoja in proizvodnje izdelka z digitalnimi elementi ter postopkov obravnavanja ranljivosti, ki vključuje:

potrebne informacije o zasnovi in razvoju izdelka z digitalnimi elementi, vključno z, kadar je ustrezno, risbami in shemami in opisom strukture sistema, iz katerega izhaja, kako sestavni deli programske opreme temeljijo drug na drugem oziroma kako se dopolnjujejo ter kako se vključujejo v celotno delovanje;

potrebne informacije in specifikacije postopkov obravnavanja ranljivosti, ki jih je vzpostavil proizvajalec, vključno s kosovnico za programsko opremo, usklajeno politiko razkrivanja ranljivosti, dokazilom o zagotavljanju kontaktnega naslova za poročanje o ranljivostih ter opisom tehničnih rešitev, izbranih za varno razširjanje posodobitev;

potrebne informacije in specifikacije postopkov proizvodnje in spremljanja izdelka z digitalnimi elementi ter preverjanja teh postopkov;

oceno tveganja za kibernetsko varnost, ki je upoštevana pri zasnovi, razvoju, proizvodnji, dobavi in vzdrževanju izdelka z digitalnimi elementi na podlagi člena 13, vključno s tem, kako se uporabljajo bistvene zahteve glede kibernetske varnosti iz dela I Priloge I;

ustrezne informacije, ki so bile upoštevane pri določitvi obdobja podpore na podlagi člena 13(8) izdelka z digitalnimi elementi;

Seznam harmoniziranih standardov, ki se uporabljajo v celoti ali delno in katerih sklici so bili objavljeni v Uradnem listu Evropske unije, skupnih specifikacij, kakor so določene v členu 27 te uredbe, ali evropskih certifikacijskih shem kibernetske varnost, sprejetih na podlagi Uredba (EU) 2019/881 na podlagi člena 27(8) te uredbe ter, kadar ti harmonizirani standardi, skupne specifikacije ali evropske certifikacijske sheme kibernetske varnosti niso bili uporabljeni, opis rešitev, sprejetih za izpolnitev bistvenih zahtev glede kibernetske varnosti iz delov I in II Priloge I, vključno s seznamom drugih ustreznih tehničnih specifikacij, ki so bile uporabljene. V primeru delne uporabe harmoniziranih standardov, skupnih specifikacij ali evropskih certifikacijskih shem kibernetske varnosti se v tehnični dokumentaciji navedejo deli, ki so bili uporabljeni;

poročila o preskusih, opravljenih za preverjanje skladnosti izdelka in postopkov obravnavanja ranljivosti z veljavnimi bistvenimi zahtevami glede kibernetske varnosti, kakor so določene v delih I in II Priloge I;

izvod EU izjave o skladnosti;

kadar je ustrezno, kosovnico za programsko opremo na podlagi obrazložene zahteve organa za nadzor trga, če je to potrebno, da lahko navedeni organ preveri skladnost z bistvenimi zahtevami glede kibernetske varnosti iz Priloge 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

Pooblaščeni zastopniki

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