Il-CRA; Annessi 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.

l-isem, l-isem kummerċjali rreġistrat jew it-trademark irreġistrata tal-manifattur, u l-indirizz postali, l-indirizz tal-posta elettronika jew kuntatt diġitali ieħor kif ukoll, fejn ikun disponibbli, is-sit web fejn jista’ jiġi kkuntattjat il-manifattur;

il-punt uniku ta’ kuntatt fejn tista’ tiġi rrapportata u riċevuta informazzjoni dwar il-vulnerabbiltajiet tal-prodott b’elementi diġitali, u fejn tista’ tinstab il-politika tal-manifattur dwar id-divulgazzjoni kkoordinata tal-vulnerabbiltajiet;

l-isem u t-tip u kwalunkwe informazzjoni addizzjonali li tippermetti l-identifikazzjoni unika tal-prodott b’elementi diġitali;

l-iskop maħsub tal-prodott b’elementi diġitali, inkluż l-ambjent tas-sigurtà pprovdut mill-manifattur, kif ukoll il-funzjonalitajiet essenzjali tal-prodott u u l-informazzjoni dwar il-proprjetajiet tas-sigurtà;

kwalunkwe ċirkostanza magħrufa jew prevedibbli, relatata mal-użu tal-prodott b’elementi diġitali f’konformità mal-iskop maħsub tiegħu jew f’kundizzjonijiet ta’ użu ħażin raġonevolment prevedibbli, li tista’ twassal għal riskji sinifikanti għaċ-ċibersigurtà;

fejn ikun applikabbli, l-indirizz tal-Internet li fih tista’ tiġi aċċessata d-dikjarazzjoni ta’ konformità tal-UE;

it-tip ta’ appoġġ tekniku għas-sigurtà offrut mill-manifattur u d-data tat-tmiem tal-perjodu ta’ appoġġ li matulu l-utenti jistgħu jistennew li l-vulnerabbiltajiet jiġu ġestiti u li jirċievu aġġornamenti tas-sigurtà;

istruzzjonijiet dettaljati jew indirizz tal-Internet li jirreferi għal tali istruzzjonijiet dettaljati u informazzjoni dwar:

il-miżuri meħtieġa matul l-ikkummissjonar inizjali u matul il-ħajja tal-prodott b’elementi diġitali biex jiġi żgurat l-użu sikur tiegħu;

kif il-bidliet fil-prodott b’elementi diġitali jistgħu jaffettwaw is-sigurtà tad-data;

kif jistgħu jiġu installati aġġornamenti rilevanti għas-sigurtà;

id-dekummissjonar sikur tal-prodott b’elementi diġitali, inkluża informazzjoni dwar kif id-data tal-utent tista’ titneħħa b’mod sikur;

kif il-konfigurazzjoni prestabbilita li tippermetti l-installazzjoni awtomatika ta’ aġġornamenti tas-sigurtà, kif meħtieġ mill-Parti I, il-punt (2)(c), tal-Anness I, tista’ tiġi diżattivata;

fejn il-prodott b’elementi diġitali jkun maħsub biex jiġi integrat fi prodotti oħra b’elementi diġitali, l-informazzjoni meħtieġa biex l-integratur ikun konformi mar-rekwiżiti essenzjali taċ-ċibersigurtà stabbiliti fl-Anness I u r-rekwiżiti ta’ dokumentazzjoni stabbiliti fl-Anness VII.

Jekk il-manifattur jiddeċiedi li jqiegħed il-lista ta’ materjali tas-software disponibbli għall-utent, informazzjoni dwar fejn tista’ tiġi aċċessata l-lista ta’ materjali tas-software.

Sistemi ta’ ġestjoni tal-identità u software u hardware ta’ ġestjoni tal-aċċess privileġġat, inklużi l-qarrejja tal-awtentikazzjoni u tal-kontroll tal-aċċess, inklużi qarrejja bijometriċi

Browsers indipendenti u inkorporati

Maniġers tal-passwords

Software li jfittex għal software malizzjuż, ineħħih, jew jitfgħu fi kwarantina

Prodotti b’elementi diġitali bil-funzjoni ta’ network privat virtwali (VPN)

Sistemi ta’ ġestjoni tan-network

Sistemi ta’ informazzjoni dwar is-sigurtà u ta’ ġestjoni tal-avvenimenti (SIEM)

Maniġers tal-ibbutjar

Infrastruttura tal-kjavi pubblika u software għall-ħruġ ta’ ċertifikati diġitali

Interfaċċi fiżiċi u virtwali tan-network

Sistemi operattivi

Routers, modems maħsuba għall-konnessjoni mal-Internet, u swiċċijiet

Mikroproċessuri b’funzjonalitajiet relatati mas-sigurtà

Mikrokontrolluri b’funzjonalitajiet relatati mas-sigurtà

Ċirkwiti integrati speċifiċi għall-applikazzjoni (ASIC) u matriċi ta’ gates programmabbli mill-utent (FPGA) b’funzjonalitajiet relatati mas-sigurtà

Assistenti virtwali intelliġenti bi skop ġenerali għad-dar

Prodotti intelliġenti għad-dar b’funzjonalitajiet tas-sigurtà, inklużi serraturi intelliġenti tal-bibien, kameras tas-sigurtà, sistemi ta’ monitoraġġ tat-trabi u sistemi tal-allarm

Ġugarelli konnessi mal-Internet koperti mid-Direttiva 2009/48/KE tal-Parlament Ewropew u tal-Kunsill (1) li għandhom karatteristiċi interattivi soċjali (eż. taħdit jew iffilmjar) jew li għandhom karatteristiċi ta’ trekkjar tal-pożizzjoni

Prodotti personali li jintlibsu maħsuba biex jintlibsu jew jitqiegħdu fuq ġisem uman li għandhom skop ta’ monitoraġġ tas-saħħa (bħat-trekkjar) u li għalihom ma japplikax ir-Regolament (UE) 2017/745 jew (UE) 2017/746, jew prodotti personali li jintlibsu li huma maħsuba għall-użu mit-tfal u għat-tfal

Iperviżieri u sistemi ta’ runtime tal-kontenituri li jappoġġjaw l-eżekuzzjoni virtwalizzata ta’ sistemi operattivi u ambjenti simili

Firewalls, sistemi ta’ detezzjoni tal-intrużjoni u ta’ prevenzjoni

Mikroproċessuri reżistenti għat-tbagħbis

Mikrokontrolluri reżistenti għat-tbagħbis

L-isem u t-tip u kwalunkwe informazzjoni addizzjonali li tippermetti l-identifikazzjoni unika tal-prodott b’elementi diġitali

L-isem u l-indirizz tal-manifattur jew tar-rappreżentant awtorizzat tiegħu

Stqarrija li d-dikjarazzjoni ta’ konformità tal-UE qed tinħareġ bir-responsabbiltà unika tal-fornitur

L-għan tad-dikjarazzjoni (identifikazzjoni tal-prodott b’elementi diġitali li tippermetti t-traċċabbiltà, li tista’ tinkludi ritratt, fejn ikun xieraq)

Stqarrija li l-għan tad-dikjarazzjoni deskritta hawn fuq huwa konformi mal-leġiżlazzjoni rilevanti tal-Unjoni dwar l-armonizzazzjoni

Referenzi għal kwalunkwe standard armonizzat rilevanti użat jew għal kwalunkwe speċifikazzjoni komuni jew ċertifikazzjoni taċ-ċibersigurtà oħra li fir-rigward tagħhom tiġi ddikjarata l-konformità

Fejn ikun applikabbli, l-isem u n-numru tal-korp notifikat, deskrizzjoni tal-proċedura tal-valutazzjoni ta’ konformità mwettqa u identifikazzjoni taċ-ċertifikat maħruġ

Informazzjoni addizzjonali:

deskrizzjoni ġenerali tal-prodott b’elementi diġitali, inklużi:

l-iskop maħsub tiegħu;

il-verżjonijiet ta’ software li jaffettwaw il-konformità mar-rekwiżiti essenzjali taċ-ċibersigurtà;

fejn il-prodott b’elementi diġitali huwa prodott tal-hardware, ritratti jew illustrazzjonijiet li juru karatteristiċi esterni, immarkar u tqassim intern;

l-informazzjoni u l-istruzzjonijiet għall-utent kif stabbiliti fl-Anness II;

deskrizzjoni tad-disinn, tal-iżvilupp u tal-produzzjoni tal-prodott b’elementi diġitali u tal-proċessi tal-ġestjoni tal-vulnerabbiltà, inklużi:

l-informazzjoni meħtieġa dwar id-disinn u l-iżvilupp tal-prodott b’elementi diġitali, inkluż, fejn ikun applikabbli, tpinġijiet u skemi u deskrizzjoni tal-arkitettura tas-sistema li tispjega kif il-komponenti tas-software jibnu fuq xulxin u jintegraw fl-ipproċessar ġenerali, jew jalimentaw lil xulxin;

l-informazzjoni u l-ispeċifikazzjonijiet meħtieġa tal-proċessi ta’ ġestjoni tal-vulnerabbiltà stabbiliti mill-manifattur, inklużi l-lista ta’ materjali tas-software, il-politika dwar id-divulgazzjoni kkoordinata tal-vulnerabbiltajiet, evidenza tal-għoti ta’ indirizz ta’ kuntatt għar-rapportar tal-vulnerabbiltajiet u deskrizzjoni tas-soluzzjonijiet tekniċi magħżula għad-distribuzzjoni sigura tal-aġġornamenti;

l-informazzjoni u l-ispeċifikazzjonijiet meħtieġa tal-proċessi ta’ produzzjoni u monitoraġġ tal-prodott b’elementi diġitali u l-validazzjoni ta’ dawk il-proċessi;

valutazzjoni tar-riskji għaċ-ċibersigurtà li kontra tagħhom il-prodott b’elementi diġitali huwa ddisinjat, żviluppat, prodott, ikkonsenjat u miżmum skont l-Artikolu 13, inkluż kif ir-rekwiżiti essenzjali taċ-ċibersigurtà stabbiliti fil-Parti I tal-Anness I huma applikabbli;

informazzjoni rilevanti li tkun ittieħdet inkunsiderazzjoni biex jiġi ddeterminat il-perjodu ta’ appoġġ skont l-Artikolu 13(8) tal-prodott b’elementi diġitali;

lista tal-istandards armonizzati applikati kompletament jew parzjalment, li r-referenzi tagħhom ġew ippubblikati f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea, speċifikazzjonijiet komuni kif stabbilit fl-Artikolu 27 ta’ dan ir-Regolament jew skemi Ewropej ta’ ċertifikazzjoni taċ-ċibersigurtà adottati skont ir-Regolament (UE) 2019/881 skont l-Artikolu 27(8) ta’ dan ir-Regolament, u, fejn dawk l-istandards armonizzati, l-ispeċifikazzjonijiet komuni jew l-iskemi Ewropej ta’ ċertifikazzjoni taċ-ċibersigurtà ma jkunux ġew applikati, deskrizzjonijiet tas-soluzzjonijiet adottati biex jiġu ssodisfati r-rekwiżiti essenzjali taċ-ċibersigurtà stabbiliti fil-Partijiet I u II tal-Anness I, inkluża lista ta’ speċifikazzjonijiet tekniċi rilevanti oħra applikati. Fil-każ ta’ standards armonizzati li jkunu ġew applikati parzjalment, speċifikazzjonijiet komuni jew skemi Ewropej ta’ ċertifikazzjoni taċ-ċibersigurtà, id-dokumentazzjoni teknika għandha tispeċifika l-partijiet li jkunu ġew applikati;

rapporti tat-testijiet imwettqa biex tiġi vverifikata l-konformità tal-prodott b’elementi diġitali u tal-proċessi tal-ġestjoni tal-vulnerabbiltà mar-rekwiżiti essenzjali taċ-ċibersigurtà applikabbli kif stabbilit fil-Partijiet I u II tal-Anness I;

kopja tad-dikjarazzjoni ta’ konformità tal-UE;

fejn ikun applikabbli, il-lista ta’ materjali tas-software, wara talba motivata minn awtorità tas-sorveljanza tas-suq dment li tkun meħtieġa sabiex dik l-awtorità tkun tista’ tivverifika l-konformità mar-rekwiżiti essenzjali taċ-ċibersigurtà stabbiliti fl-Anness 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

Rappreżentanti awtorizzati

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