From 9dda826c3d544c5e7ce817f5591e3c7ea53948c5 Mon Sep 17 00:00:00 2001 From: eric-intuitem <71850047+eric-intuitem@users.noreply.github.com> Date: Tue, 7 Jan 2025 21:35:53 +0100 Subject: [PATCH] Update cra-regulation-annexes.yaml --- .../libraries/cra-regulation-annexes.yaml | 148 +++++++++--------- 1 file changed, 74 insertions(+), 74 deletions(-) diff --git a/backend/library/libraries/cra-regulation-annexes.yaml b/backend/library/libraries/cra-regulation-annexes.yaml index 27ccc28a2..68e892d67 100644 --- a/backend/library/libraries/cra-regulation-annexes.yaml +++ b/backend/library/libraries/cra-regulation-annexes.yaml @@ -159,7 +159,7 @@ objects: ref_id: '1.2' name: Part II description: "Vulnerability\_handling\_requirements" - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 assessable: false depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2 @@ -167,7 +167,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.1 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.1 description: identify and document vulnerabilities and components contained in products with digital elements, including by drawing up a software bill @@ -176,7 +176,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.2 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.2 description: in relation to the risks posed to products with digital elements, address and remediate vulnerabilities without delay, including by providing @@ -185,14 +185,14 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.3 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.3 description: apply effective and regular tests and reviews of the security of the product with digital elements; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.4 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.4 description: once a security update has been made available, share and publicly disclose information about fixed vulnerabilities, including a description @@ -206,14 +206,14 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.5 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.5 description: put in place and enforce a policy on coordinated vulnerability disclosure; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.6 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.6 description: take measures to facilitate the sharing of information about potential vulnerabilities in their product with digital elements as well as in third @@ -223,7 +223,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.7 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.7 description: provide for mechanisms to securely distribute updates for products with digital elements to ensure that vulnerabilities are fixed or mitigated @@ -232,7 +232,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2.8 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:1.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node20 ref_id: 1.2.8 description: ensure that, where security updates are available to address identified security issues, they are disseminated without delay and, unless otherwise @@ -246,7 +246,7 @@ objects: ref_id: '2' name: ANNEX II description: INFORMATION AND INSTRUCTIONS TO THE USER - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 assessable: false depth: 2 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2 @@ -255,7 +255,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.1 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.1' description: the name, registered trade name or registered trademark of the manufacturer, and the postal address, the email address or other digital contact @@ -264,7 +264,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.2 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.2' description: "the single point of contact where information about vulnerabilities\ \ of the product with digital elements can be reported and received, and where\ @@ -273,14 +273,14 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.3 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.3' description: name and type and any additional information enabling the unique identification of the product with digital elements ; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.4 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.4' description: "the intended purpose of the product with digital elements, including\ \ the security environment provided by the manufacturer, as well as the product\u2019\ @@ -288,7 +288,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.5 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.5' description: 'any known or foreseeable circumstance, related to the use of the product with digital elements in accordance with its intended purpose or under @@ -297,14 +297,14 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.6 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.6' description: 'where applicable, the internet address at which the EU declaration of conformity can be accessed; ' - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.7 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.7' description: the type of technical security support offered by the manufacturer and the end-date of the support period during which users can expect vulnerabilities @@ -312,7 +312,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.8 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.8' description: 'detailed instructions or an internet address referring to such detailed instructions and information on:' @@ -363,7 +363,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2.9 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node30 ref_id: '2.9' description: If the manufacturer decides to make available the software bill of materials to the user, information on where the software bill of materials @@ -569,7 +569,7 @@ objects: ref_id: '5' name: ANNEX V description: EU DECLARATION OF CONFORMITY - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 assessable: false depth: 2 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5 @@ -578,41 +578,41 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.1 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.1' description: Name and type and any additional information enabling the unique identification of the product with digital elements; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.2 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.2' description: Name and address of the manufacturer or its authorised representative; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.3 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.3' description: A statement that the EU declaration of conformity is issued under the sole responsibility of the provider; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.4 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.4' description: Object of the declaration (identification of the product with digital elements allowing traceability, which may include a photograph, where appropriate); - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.5 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.5' description: A statement that the object of the declaration described above is in conformity with the relevant Union harmonisation legislation; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.6 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.6' description: References to any relevant harmonised standards used or any other common specification or cybersecurity certification in relation to which conformity @@ -620,7 +620,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.7 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.7' description: Where applicable, the name and number of the notified body, a description of the conformity assessment procedure performed and identification of the @@ -628,7 +628,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5.8 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:5:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node77 ref_id: '5.8' description: 'Additional information: @@ -642,13 +642,13 @@ objects: ref_id: '6' name: ANNEX VI description: SIMPLIFIED EU DECLARATION OF CONFORMITY - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:6:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node87 assessable: false depth: 2 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:6 description: 'The simplified EU declaration of conformity referred to in Article 13(20) shall be provided as follows:' - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:6:2 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node88 assessable: true depth: 2 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:6 @@ -656,7 +656,7 @@ objects: elements type [designation of type of product with digital element] is in compliance with Regulation (EU) .../... of the European Parliament and of the Council1. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:6:3 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node89 assessable: true depth: 2 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:6 @@ -668,7 +668,7 @@ objects: ref_id: '7' name: ANNEX VII description: CONTENTS OF THE TECHNICAL DOCUMENTATION - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 assessable: true depth: 2 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7 @@ -678,7 +678,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.1 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.1' description: 'a general description of the product with digital elements, including:' - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.1.a @@ -710,7 +710,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.2 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.2' description: 'a description of the design, development and production of the product with digital @@ -747,7 +747,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.3 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.3' description: an assessment of the cybersecurity risks against which the product with digital elements is designed, developed, produced, delivered and maintained @@ -756,7 +756,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.4 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.4' description: relevant information that was taken into account to determine the support period as referred to in Article 13(8) of the product with digital @@ -764,7 +764,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.5 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.5' description: a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European @@ -781,7 +781,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.6 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.6' description: reports of the tests carried out to verify the conformity of the product with digital elements and of the vulnerability handling processes @@ -790,13 +790,13 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.7 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.7' description: a copy of the EU declaration of conformity; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7.8 assessable: true depth: 3 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:7:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node91 ref_id: '7.8' description: 'where applicable, the software bill of materials, further to a reasoned request from a market surveillance authority provided that it is @@ -879,7 +879,7 @@ objects: parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.1 ref_id: 8.1.5 description: Authorised representatives - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.1:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node116 assessable: true depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.1 @@ -921,7 +921,7 @@ objects: ref_id: 8.2.3 description: 'The manufacturer shall lodge an application for EU-type examination with a single notified body of its choice. ' - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node121 assessable: false depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2 @@ -929,21 +929,21 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2.3.1 assessable: false depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node121 ref_id: 8.2.3.1 description: the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2.3.2 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node121 ref_id: 8.2.3.2 description: a written declaration that the same application has not been lodged with any other notified body; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2.3.3 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node121 ref_id: 8.2.3.3 description: the technical documentation, which shall make it possible to assess the conformity of the product with digital elements with the applicable essential @@ -957,7 +957,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2.3.4 assessable: true depth: 4 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node121 ref_id: 8.2.3.4 description: the supporting evidence for the adequacy of the technical design and development solutions and vulnerability handling processes. This supporting @@ -1041,7 +1041,7 @@ objects: 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. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:2 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node134 assessable: true depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2 @@ -1049,7 +1049,7 @@ objects: to allow the conformity of manufactured or developed products with digital elements with the examined type and vulnerability handling processes to be evaluated and to allow for in-service control. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:3 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node135 assessable: true depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2 @@ -1068,7 +1068,7 @@ objects: applicable essential requirements set out in Annex I to this Regulation, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:4 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node137 assessable: true depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2 @@ -1097,7 +1097,7 @@ objects: 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. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:5 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node140 assessable: true depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2 @@ -1105,7 +1105,7 @@ objects: the EU-type examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the certificates and additions thereto which it has issued. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2:6 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node141 assessable: true depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.2 @@ -1249,7 +1249,7 @@ objects: description: The manufacturer shall lodge an application for assessment of its quality system with the notified body of its choice, for the products with digital elements concerned. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node156 assessable: false depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 @@ -1257,14 +1257,14 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.1.1 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node156 ref_id: 8.4.3.1.1 description: the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.1.2 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node156 ref_id: 8.4.3.1.2 description: the technical documentation for one model of each category of products with digital elements intended to be manufactured or developed. The technical @@ -1273,13 +1273,13 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.1.3 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node156 ref_id: 8.4.3.1.3 description: the documentation concerning the quality system; and - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.1.4 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:1 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node156 ref_id: 8.4.3.1.4 description: a written declaration that the same application has not been lodged with any other notified body. @@ -1292,7 +1292,7 @@ objects: digital elements with the essential requirements set out in Annex I, Part I, and compliance of the vulnerability handling processes put in place by the manufacturer with the requirements set out in Annex I, Part II. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:2 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node162 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 @@ -1301,7 +1301,7 @@ objects: policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 assessable: false depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 @@ -1309,7 +1309,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.1 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.1 description: the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design, development, product quality @@ -1317,7 +1317,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.2 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.2 description: the technical design and development specifications, including standards, that will be applied and, where the relevant harmonised standards @@ -1327,7 +1327,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.3 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.3 description: the procedural specifications, including standards, that will be applied and, where the relevant harmonised standards or technical specifications @@ -1337,7 +1337,7 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.4 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.4 description: the design and development control, as well as design and development verification techniques, processes and systematic actions that will be used @@ -1346,28 +1346,28 @@ objects: - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.5 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.5 description: the corresponding production, quality control and quality assurance techniques, processes and systematic actions that will be used; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.6 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.6 description: the examinations and tests that will be carried out before, during and after production, and the frequency with which they will be carried out; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.7 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.7 description: the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3.2.8 assessable: true depth: 5 - parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:3 + parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node163 ref_id: 8.4.3.2.8 description: the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system. @@ -1378,7 +1378,7 @@ objects: ref_id: 8.4.3.3 description: The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:4 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node173 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 @@ -1386,7 +1386,7 @@ objects: of the elements of the quality system that comply with the corresponding specifications of the national standard that implements the relevant harmonised standard or technical specification. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:5 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node174 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 @@ -1400,13 +1400,13 @@ objects: the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the product with digital elements with those requirements. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:6 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node175 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 description: The manufacturer or its authorised representative shall be notified of the decision. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:7 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node176 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 @@ -1427,14 +1427,14 @@ objects: ref_id: 8.4.3.5 description: The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:8 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node179 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 description: The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3:9 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node180 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.3 @@ -1516,7 +1516,7 @@ objects: for 10 years after the product with digital elements has been placed on the market or for the support period, whichever is longer. The declaration of conformity shall identify the product model for which it has been drawn up. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.5:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node191 assessable: true depth: 4 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4.5 @@ -1566,7 +1566,7 @@ objects: 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. - - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4:1 + - urn: urn:intuitem:risk:req_node:cra-resolution-annexes:node198 assessable: true depth: 3 parent_urn: urn:intuitem:risk:req_node:cra-resolution-annexes:8.4