CRA; bilag 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.

Fabrikantens navn, registrerede firmanavn eller registrerede varemærke og postadresse, e-mailadresse eller andre digitale kontaktoplysninger samt, hvis et sådant foreligger, det websted, hvor fabrikanten kan kontaktes

det centrale kontaktpunkt, hvor oplysninger om sårbarheder i produktet med digitale elementer kan indberettes og modtages, og hvor fabrikantens politik for koordineret offentliggørelse af sårbarheder kan findes

navn og type og eventuelle yderligere oplysninger, der gør det muligt entydigt at identificere produktet med digitale elementer

det tilsigtede formål med produktet med digitale elementer, herunder det sikkerhedsmiljø, som fabrikanten leverer, samt produktets væsentlige funktioner og oplysninger om sikkerhedsegenskaberne

alle kendte eller forudsigelige omstændigheder vedrørende anvendelsen af produktet med digitale elementer i overensstemmelse med dets tilsigtede formål eller ved fejlanvendelse, der med rimelighed kan forudses, der kan medføre betydelige cybersikkerhedsrisici

i givet fald den internetadresse, hvor der er adgang til EU-overensstemmelseserklæringen

den type tekniske sikkerhedsstøtte, som fabrikanten tilbyder, og slutdatoen for den supportperiode, hvor brugerne kan forvente, at sårbarheder håndteres, og hvor brugerne kan forvente at modtage sikkerhedsopdateringer

detaljerede anvisninger eller en internetadresse med henvisning til sådanne detaljerede anvisninger og oplysninger om:

de nødvendige foranstaltninger ved første ibrugtagning og i hele levetiden for produktet med digitale elementer for at sikre en sikker anvendelse heraf

hvordan ændringer af produktet med digitale elementer kan påvirke datasikkerheden

hvordan sikkerhedsrelevante opdateringer kan installeres

sikker nedlukning af produktet med digitale elementer, herunder oplysninger om, hvordan brugerdata kan fjernes sikkert

hvordan den standardindstilling, der muliggør automatisk installation af sikkerhedsopdateringer som krævet af bilag I, del I, nr. 2, litra c), kan slås fra

hvor produktet med digitale elementer er beregnet til at blive integreret i andre produkter med digitale elementer, de oplysninger, der er nødvendige for, at integratoren kan opfylde de væsentlige cybersikkerhedskrav, der er fastlagt i bilag I, og de dokumentationskrav, der er fastlagt i bilag VII

hvis fabrikanten beslutter at stille softwarekomponentlisten til rådighed for brugeren, oplysninger om, hvor softwarekomponentlisten kan tilgås.

Software og hardware til identitetsstyringssystemer og til styring af privilegeret adgang, herunder autentificerings- og adgangskontrollæsere, herunder biometriske læsere

Enkeltstående og indlejrede browsere

Adgangskoder

Software, der søger efter, fjerner eller sætter ondsindet software i karantæne

Produkter med digitale elementer, der fungerer som et virtuelt privat netværk (VPN)

Netstyringssystemer

Systemer til sikkerhedsinformations- og hændelseshåndtering (SIEM)

Boot-managere

Public key-infrastruktur og software for udstedelse af digitale certifikater

Fysiske og virtuelle netværksgrænseflader

Operativsystemer

Routere, modemmer til internetforbindelse og afbrydere

Mikroprocessorer med sikkerhedsrelaterede funktioner

Mikrocontrollere med sikkerhedsrelaterede funktioner

Applikationsspecifikke integrerede kredsløb (ASIC) og programmerbare porte (FPPT) med sikkerhedsrelaterede funktioner

Virtuelle assistenter til generelle formål i intelligente bygninger

Produkter til intelligente bygninger med sikkerhedsfunktioner, herunder intelligente dørlåse, sikkerhedskameraer, systemer til overvågning af spædbørn og alarmsystemer

Internetforbundet legetøj, der er omfattet af Europa-Parlamentets og Rådets direktiv 2009/48/EF (1), og som har sociale interaktive funktioner (f.eks. at det kan tale eller filme), eller som har lokaliseringsfunktioner

Personlige wearable-produkter, der skal bæres af eller anbringes på et menneskelegeme, og som har et sundhedsovervågningsformål (såsom sporing), og som forordning (EU) 2017/745 eller (EU) 2017/746 ikke finder anvendelse på, eller personlige wearable-produkter, der skal anvendes af og til børn.

Hypervisorer og container runtime-systemer, der understøtter virtuel udførelse af operativsystemer og lignende miljøer

Firewalls, systemer til opdagelse og forebyggelse af indtrængen

Mikroprocessorer, der er sikret mod manipulation

Mikrocontrollere, der er sikret mod manipulation.

Navn og type og eventuelle yderligere oplysninger, der gør det muligt entydigt at identificere produktet med digitale elementer.

Navn og adresse på fabrikanten eller dennes bemyndigede repræsentant.

En erklæring om, at EU-overensstemmelseserklæringen udstedes på udbyderens eksklusive ansvar.

Erklæringens genstand (identifikation af produktet med digitale elementer, så det kan spores, hvilket kan omfatte et foto, hvor det er relevant).

En erklæring om, at genstanden for erklæringen beskrevet ovenfor er i overensstemmelse med den relevante EU-harmoniseringslovgivning.

Henvisninger til de relevante anvendte harmoniserede standarder eller referencer til anden fælles specifikation eller cybersikkerhedscertificering, som der erklæres overensstemmelse med.

Hvis det er relevant, navnet og nummeret på det bemyndigede organ, en beskrivelse af den udførte overensstemmelsesvurderingsprocedure og identifikation af den udstedte attest.

Yderligere oplysninger:

en generel beskrivelse af produktet med digitale elementer, herunder:

dets tilsigtede formål

softwareversioner, der påvirker overholdelsen af de væsentlige cybersikkerhedskrav

hvis produktet med digitale elementer er et hardwareprodukt, fotografier eller illustrationer af dets eksterne elementer, mærkninger og intern indretning

oplysninger og anvisninger til brugeren som anført bilag II

en beskrivelse af design, udvikling og produktion af produktet med digitale elementer og af sårbarhedshåndteringsprocesser, herunder:

nødvendige oplysninger om design og udvikling af produktet med digitale elementer, herunder i givet fald tegninger og skemaer og en beskrivelse af systemarkitekturen, der forklarer, hvordan softwarekomponenter bygger på eller indgår i hinanden og integreres i den samlede behandling

nødvendige oplysninger om og specifikationer for de sårbarhedshåndteringsprocesser, som fabrikanten har indført, herunder softwarekomponentlisten, politikken for koordineret offentliggørelse af sårbarheder, dokumentation for angivelse af en kontaktadresse til indberetning af sårbarheder og en beskrivelse af de tekniske løsninger, der er valgt til sikker distribution af opdateringer

nødvendige oplysninger om og specifikationer for produktions- og overvågningsprocesserne for produktet med digitale elementer og validering af disse processer

en vurdering af de cybersikkerhedsrisici, som produktet med digitale elementer i henhold til artikel 13 designes, udvikles, produceres, leveres og vedligeholdes til at beskytte imod, herunder hvordan de væsentlige cybersikkerhedskrav i bilag I, del 1, finder anvendelse

relevante oplysninger, der blev taget i betragtning ved fastlæggelsen af supportperioden i henhold til artikel 13, stk. 8, for produktet med digitale elementer

en liste over de helt eller delvist anvendte harmoniserede standarder, hvis referencer er offentliggjort i Den Europæiske Unions Tidende, fælles specifikationer som fastsat i denne forordnings artikel 27 eller europæiske cybersikkerhedscertificeringsordninger, der er vedtaget i henhold til forordning (EU) 2019/881 i henhold til nærværende forordnings artikel 27, stk. 8, og, hvor disse harmoniserede standarder, fælles specifikationer eller europæiske cybersikkerhedscertificeringsordninger ikke er blevet anvendt, beskrivelser af de løsninger, der er anvendt for at opfylde de væsentlige cybersikkerhedskrav i bilag I, del I og II, herunder en liste over andre relevante tekniske specifikationer, som er anvendt. I tilfælde af delvis anvendelse af harmoniserede standarder, fælles specifikationer eller europæiske cybersikkerhedscertificeringsordninger skal den tekniske dokumentation angive, hvilke dele der er anvendt

rapporter om de afprøvninger, der er foretaget for at kontrollere, at produktet med digitale elementer og sårbarhedshåndteringsprocesserne opfylder de gældende væsentlige cybersikkerhedskrav som fastsat i bilag I, del I og II

en kopi af EU-overensstemmelseserklæringen

i givet fald softwarekomponentlisten efter en begrundet anmodning fra en markedsovervågningsmyndighed, forudsat at det er nødvendigt for, at denne myndighed kan kontrollere overholdelsen af de væsentlige cybersikkerhedskrav i bilag 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

Bemyndigede repræsentanter

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