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class="menu-item-description">General provisions</div></a> <ul class="sub-menu"> <li id="menu-item-1349" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1349"><a href="https://ai-act-law.eu/article/1/">Art. 1<div class="menu-item-description">Subject matter</div></a></li> <li id="menu-item-1350" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1350"><a href="https://ai-act-law.eu/article/2/">Art. 2<div class="menu-item-description">Scope</div></a></li> <li id="menu-item-1351" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1351"><a href="https://ai-act-law.eu/article/3/">Art. 3<div class="menu-item-description">Definitions</div></a></li> <li id="menu-item-1352" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1352"><a href="https://ai-act-law.eu/article/4/">Art. 4<div class="menu-item-description">AI literacy</div></a></li> </ul> </li> <li id="menu-item-1347" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1347"><a href="https://ai-act-law.eu/chapter/2/">Chapter 2 (Art. 5)<div class="menu-item-description">Prohibited AI practices</div></a> <ul class="sub-menu"> <li id="menu-item-1353" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1353"><a href="https://ai-act-law.eu/article/5/">Art. 5<div class="menu-item-description">Prohibited AI practices</div></a></li> </ul> </li> <li id="menu-item-1346" class="menu-item menu-item-type-post_type menu-item-object-chapter current-menu-ancestor current-menu-parent menu-item-has-children menu-item-1346"><a href="https://ai-act-law.eu/chapter/3/">Chapter 3 (Art. 6-49)<div class="menu-item-description">High-risk AI systems</div></a> <ul class="sub-menu"> <li id="menu-item-1356" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1356"><a>Section 1<div class="menu-item-description">Classification of AI systems as high-risk</div></a></li> <li id="menu-item-1354" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1354"><a href="https://ai-act-law.eu/article/6/">Art. 6<div class="menu-item-description">Classification rules for high-risk AI systems</div></a></li> <li id="menu-item-1355" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1355"><a href="https://ai-act-law.eu/article/7/">Art. 7<div class="menu-item-description">Amendments to Annex III</div></a></li> <li id="menu-item-1357" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1357"><a>Section 2<div class="menu-item-description">Requirements for high-risk AI systems</div></a></li> <li id="menu-item-1358" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1358"><a href="https://ai-act-law.eu/article/8/">Art. 8<div class="menu-item-description">Compliance with the requirements</div></a></li> <li id="menu-item-1359" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1359"><a href="https://ai-act-law.eu/article/9/">Art. 9<div class="menu-item-description">Risk management system</div></a></li> <li id="menu-item-1361" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1361"><a href="https://ai-act-law.eu/article/10/">Art. 10<div class="menu-item-description">Data and data governance</div></a></li> <li id="menu-item-1372" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1372"><a href="https://ai-act-law.eu/article/11/">Art. 11<div class="menu-item-description">Technical documentation</div></a></li> <li id="menu-item-1377" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1377"><a href="https://ai-act-law.eu/article/12/">Art. 12<div class="menu-item-description">Record-keeping</div></a></li> <li id="menu-item-1378" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1378"><a href="https://ai-act-law.eu/article/13/">Art. 13<div class="menu-item-description">Transparency and provision of information to deployers</div></a></li> <li id="menu-item-1379" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1379"><a href="https://ai-act-law.eu/article/14/">Art. 14<div class="menu-item-description">Human oversight</div></a></li> <li id="menu-item-1380" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1380"><a href="https://ai-act-law.eu/article/15/">Art. 15<div class="menu-item-description">Accuracy, robustness and cybersecurity</div></a></li> <li id="menu-item-1498" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1498"><a>Section 3<div class="menu-item-description">Obligations of providers and deployers of high-risk AI systems and other parties</div></a></li> <li id="menu-item-1381" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1381"><a href="https://ai-act-law.eu/article/16/">Art. 16<div class="menu-item-description">Obligations of providers of high-risk AI systems</div></a></li> <li id="menu-item-1382" class="menu-item menu-item-type-post_type menu-item-object-article current-menu-item menu-item-1382"><a href="https://ai-act-law.eu/article/17/" aria-current="page">Art. 17<div class="menu-item-description">Quality management system</div></a></li> <li id="menu-item-1383" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1383"><a href="https://ai-act-law.eu/article/18/">Art. 18<div class="menu-item-description">Documentation keeping</div></a></li> <li id="menu-item-1384" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1384"><a href="https://ai-act-law.eu/article/19/">Art. 19<div class="menu-item-description">Automatically generated logs</div></a></li> <li id="menu-item-1386" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1386"><a href="https://ai-act-law.eu/article/20/">Art. 20<div class="menu-item-description">Corrective actions and duty of information</div></a></li> <li id="menu-item-1387" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1387"><a href="https://ai-act-law.eu/article/21/">Art. 21<div class="menu-item-description">Cooperation with competent authorities</div></a></li> <li id="menu-item-1388" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1388"><a href="https://ai-act-law.eu/article/22/">Art. 22<div class="menu-item-description">Authorised representatives of providers of high-risk AI systems</div></a></li> <li id="menu-item-1389" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1389"><a href="https://ai-act-law.eu/article/23/">Art. 23<div class="menu-item-description">Obligations of importers</div></a></li> <li id="menu-item-1390" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1390"><a href="https://ai-act-law.eu/article/24/">Art. 24<div class="menu-item-description">Obligations of distributors</div></a></li> <li id="menu-item-1391" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1391"><a href="https://ai-act-law.eu/article/25/">Art. 25<div class="menu-item-description">Responsibilities along the AI value chain</div></a></li> <li id="menu-item-1392" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1392"><a href="https://ai-act-law.eu/article/26/">Art. 26<div class="menu-item-description">Obligations of deployers of high-risk AI systems</div></a></li> <li id="menu-item-1393" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1393"><a href="https://ai-act-law.eu/article/27/">Art. 27<div class="menu-item-description">Fundamental rights impact assessment for high-risk AI systems</div></a></li> <li id="menu-item-1499" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1499"><a>Section 4<div class="menu-item-description">Notifying authorities and notified bodies</div></a></li> <li id="menu-item-1394" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1394"><a href="https://ai-act-law.eu/article/28/">Art. 28<div class="menu-item-description">Notifying authorities</div></a></li> <li id="menu-item-1395" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1395"><a href="https://ai-act-law.eu/article/29/">Art. 29<div class="menu-item-description">Application of a conformity assessment body for notification</div></a></li> <li id="menu-item-1397" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1397"><a href="https://ai-act-law.eu/article/30/">Art. 30<div class="menu-item-description">Notification procedure</div></a></li> <li id="menu-item-1398" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1398"><a href="https://ai-act-law.eu/article/31/">Art. 31<div class="menu-item-description">Requirements relating to notified bodies</div></a></li> <li id="menu-item-1399" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1399"><a href="https://ai-act-law.eu/article/32/">Art. 32<div class="menu-item-description">Presumption of conformity with requirements relating to notified bodies</div></a></li> <li id="menu-item-1400" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1400"><a href="https://ai-act-law.eu/article/33/">Art. 33<div class="menu-item-description">Subsidiaries of notified bodies and subcontracting</div></a></li> <li id="menu-item-1401" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1401"><a href="https://ai-act-law.eu/article/34/">Art. 34<div class="menu-item-description">Operational obligations of notified bodies</div></a></li> <li id="menu-item-1402" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1402"><a href="https://ai-act-law.eu/article/35/">Art. 35<div class="menu-item-description">Identification numbers and lists of notified bodies</div></a></li> <li id="menu-item-1403" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1403"><a href="https://ai-act-law.eu/article/36/">Art. 36<div class="menu-item-description">Changes to notifications</div></a></li> <li id="menu-item-1404" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1404"><a href="https://ai-act-law.eu/article/37/">Art. 37<div class="menu-item-description">Challenge to the competence of notified bodies</div></a></li> <li id="menu-item-1405" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1405"><a href="https://ai-act-law.eu/article/38/">Art. 38<div class="menu-item-description">Coordination of notified bodies</div></a></li> <li id="menu-item-1406" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1406"><a href="https://ai-act-law.eu/article/39/">Art. 39<div class="menu-item-description">Conformity assessment bodies of third countries</div></a></li> <li id="menu-item-1500" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1500"><a>Section 5<div class="menu-item-description">Standards, conformity assessment, certificates, registration</div></a></li> <li id="menu-item-1408" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1408"><a href="https://ai-act-law.eu/article/40/">Art. 40<div class="menu-item-description">Harmonised standards and standardisation deliverables</div></a></li> <li id="menu-item-1409" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1409"><a href="https://ai-act-law.eu/article/41/">Art. 41<div class="menu-item-description">Common specifications</div></a></li> <li id="menu-item-1410" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1410"><a href="https://ai-act-law.eu/article/42/">Art. 42<div class="menu-item-description">Presumption of conformity with certain requirements</div></a></li> <li id="menu-item-1411" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1411"><a href="https://ai-act-law.eu/article/43/">Art. 43<div class="menu-item-description">Conformity assessment</div></a></li> <li id="menu-item-1412" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1412"><a href="https://ai-act-law.eu/article/44/">Art. 44<div class="menu-item-description">Certificates</div></a></li> <li id="menu-item-1413" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1413"><a href="https://ai-act-law.eu/article/45/">Art. 45<div class="menu-item-description">Information obligations of notified bodies</div></a></li> <li id="menu-item-1414" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1414"><a href="https://ai-act-law.eu/article/46/">Art. 46<div class="menu-item-description">Derogation from conformity assessment procedure</div></a></li> <li id="menu-item-1415" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1415"><a href="https://ai-act-law.eu/article/47/">Art. 47<div class="menu-item-description">EU declaration of conformity</div></a></li> <li id="menu-item-1416" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1416"><a href="https://ai-act-law.eu/article/48/">Art. 48<div class="menu-item-description">CE marking</div></a></li> <li id="menu-item-1417" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1417"><a href="https://ai-act-law.eu/article/49/">Art. 49<div class="menu-item-description">Registration</div></a></li> </ul> </li> <li id="menu-item-1418" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1418"><a href="https://ai-act-law.eu/chapter/4/">Chapter 4 (Art. 50)<div class="menu-item-description">Transparency obligations for providers and deployers of certain AI systems</div></a> <ul class="sub-menu"> <li id="menu-item-1424" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1424"><a href="https://ai-act-law.eu/article/50/">Art. 50<div class="menu-item-description">Transparency obligations for providers and deployers of certain AI systems</div></a></li> </ul> </li> <li id="menu-item-1419" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1419"><a href="https://ai-act-law.eu/chapter/5/">Chapter 5 (Art. 51-56)<div class="menu-item-description">General-purpose AI models</div></a> <ul class="sub-menu"> <li id="menu-item-1501" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1501"><a>Section 1<div class="menu-item-description">Classification rules</div></a></li> <li id="menu-item-1425" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1425"><a href="https://ai-act-law.eu/article/51/">Art. 51<div class="menu-item-description">Classification of general-purpose AI models as general-purpose AI models with systemic risk</div></a></li> <li id="menu-item-1426" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1426"><a href="https://ai-act-law.eu/article/52/">Art. 52<div class="menu-item-description">Procedure</div></a></li> <li id="menu-item-1502" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1502"><a>Section 2<div class="menu-item-description">Obligations for providers of general-purpose AI models</div></a></li> <li id="menu-item-1427" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1427"><a href="https://ai-act-law.eu/article/53/">Art. 53<div class="menu-item-description">Obligations for providers of general-purpose AI models</div></a></li> <li id="menu-item-1428" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1428"><a href="https://ai-act-law.eu/article/54/">Art. 54<div class="menu-item-description">Authorised representatives of providers of general-purpose AI models</div></a></li> <li id="menu-item-1503" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1503"><a>Section 3<div class="menu-item-description">Obligations of providers of general-purpose AI models with systemic risk</div></a></li> <li id="menu-item-1429" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1429"><a href="https://ai-act-law.eu/article/55/">Art. 55<div class="menu-item-description">Obligations of providers of general-purpose AI models with systemic risk</div></a></li> <li id="menu-item-2537" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-2537"><a>Section 4<div class="menu-item-description">Codes of practice</div></a></li> <li id="menu-item-1430" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1430"><a href="https://ai-act-law.eu/article/56/">Art. 56<div class="menu-item-description">Codes of practice</div></a></li> </ul> </li> <li id="menu-item-1420" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1420"><a href="https://ai-act-law.eu/chapter/6/">Chapter 6 (Art. 57-63)<div class="menu-item-description">Measures in support of innovation</div></a> <ul class="sub-menu"> <li id="menu-item-1431" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1431"><a href="https://ai-act-law.eu/article/57/">Art. 57<div class="menu-item-description">AI regulatory sandboxes</div></a></li> <li id="menu-item-1432" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1432"><a href="https://ai-act-law.eu/article/58/">Art. 58<div class="menu-item-description">Detailed arrangements for, and functioning of, AI regulatory sandboxes</div></a></li> <li id="menu-item-1433" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1433"><a href="https://ai-act-law.eu/article/59/">Art. 59<div class="menu-item-description">Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox</div></a></li> <li id="menu-item-1443" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1443"><a href="https://ai-act-law.eu/article/60/">Art. 60<div class="menu-item-description">Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes</div></a></li> <li id="menu-item-1434" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1434"><a href="https://ai-act-law.eu/article/61/">Art. 61<div class="menu-item-description">Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes</div></a></li> <li id="menu-item-1435" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1435"><a href="https://ai-act-law.eu/article/62/">Art. 62<div class="menu-item-description">Measures for providers and deployers, in particular SMEs, including start-ups</div></a></li> <li id="menu-item-1436" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1436"><a href="https://ai-act-law.eu/article/63/">Art. 63<div class="menu-item-description">Derogations for specific operators</div></a></li> </ul> </li> <li id="menu-item-1421" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1421"><a href="https://ai-act-law.eu/chapter/7/">Chapter 7 (Art. 64-70)<div class="menu-item-description">Governance</div></a> <ul class="sub-menu"> <li id="menu-item-1504" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1504"><a>Section 1<div class="menu-item-description">Governance at Union level</div></a></li> <li id="menu-item-1437" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1437"><a href="https://ai-act-law.eu/article/64/">Art. 64<div class="menu-item-description">AI Office</div></a></li> <li id="menu-item-1438" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1438"><a href="https://ai-act-law.eu/article/65/">Art. 65<div class="menu-item-description">Establishment and structure of the European Artificial Intelligence Board</div></a></li> <li id="menu-item-1439" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1439"><a href="https://ai-act-law.eu/article/66/">Art. 66<div class="menu-item-description">Tasks of the Board</div></a></li> <li id="menu-item-1440" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1440"><a href="https://ai-act-law.eu/article/67/">Art. 67<div class="menu-item-description">Advisory forum</div></a></li> <li id="menu-item-1441" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1441"><a href="https://ai-act-law.eu/article/68/">Art. 68<div class="menu-item-description">Scientific panel of independent experts</div></a></li> <li id="menu-item-1442" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1442"><a href="https://ai-act-law.eu/article/69/">Art. 69<div class="menu-item-description">Access to the pool of experts by the Member States</div></a></li> <li id="menu-item-1505" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1505"><a>Section 2<div class="menu-item-description">National competent authorities</div></a></li> <li id="menu-item-1444" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1444"><a href="https://ai-act-law.eu/article/70/">Art. 70<div class="menu-item-description">Designation of national competent authorities and single points of contact</div></a></li> </ul> </li> <li id="menu-item-1422" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1422"><a href="https://ai-act-law.eu/chapter/8/">Chapter 8 (Art. 71)<div class="menu-item-description">EU database for high-risk AI systems</div></a> <ul class="sub-menu"> <li id="menu-item-1445" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1445"><a href="https://ai-act-law.eu/article/71/">Art. 71<div class="menu-item-description">EU database for high-risk AI systems listed in Annex III</div></a></li> </ul> </li> <li id="menu-item-1423" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1423"><a href="https://ai-act-law.eu/chapter/9/">Chapter 9 (Art. 72-94)<div class="menu-item-description">Post-market monitoring, information sharing and market surveillance</div></a> <ul class="sub-menu"> <li id="menu-item-1506" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1506"><a>Section 1<div class="menu-item-description">Post-market monitoring</div></a></li> <li id="menu-item-1446" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1446"><a href="https://ai-act-law.eu/article/72/">Art. 72<div class="menu-item-description">Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems</div></a></li> <li id="menu-item-1507" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1507"><a>Section 2<div class="menu-item-description">Sharing of information on serious incidents</div></a></li> <li id="menu-item-1447" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1447"><a href="https://ai-act-law.eu/article/73/">Art. 73<div class="menu-item-description">Reporting of serious incidents</div></a></li> <li id="menu-item-1508" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1508"><a>Section 3<div class="menu-item-description">Enforcement</div></a></li> <li id="menu-item-1448" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1448"><a href="https://ai-act-law.eu/article/74/">Art. 74<div class="menu-item-description">Market surveillance and control of AI systems in the Union market</div></a></li> <li id="menu-item-1449" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1449"><a href="https://ai-act-law.eu/article/75/">Art. 75<div class="menu-item-description">Mutual assistance, market surveillance and control of general-purpose AI systems</div></a></li> <li id="menu-item-1450" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1450"><a href="https://ai-act-law.eu/article/76/">Art. 76<div class="menu-item-description">Supervision of testing in real world conditions by market surveillance authorities</div></a></li> <li id="menu-item-1451" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1451"><a href="https://ai-act-law.eu/article/77/">Art. 77<div class="menu-item-description">Powers of authorities protecting fundamental rights</div></a></li> <li id="menu-item-1452" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1452"><a href="https://ai-act-law.eu/article/78/">Art. 78<div class="menu-item-description">Confidentiality</div></a></li> <li id="menu-item-1453" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1453"><a href="https://ai-act-law.eu/article/79/">Art. 79<div class="menu-item-description">Procedure at national level for dealing with AI systems presenting a risk</div></a></li> <li id="menu-item-1463" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1463"><a href="https://ai-act-law.eu/article/80/">Art. 80<div class="menu-item-description">Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III</div></a></li> <li id="menu-item-1454" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1454"><a href="https://ai-act-law.eu/article/81/">Art. 81<div class="menu-item-description">Union safeguard procedure</div></a></li> <li id="menu-item-1455" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1455"><a href="https://ai-act-law.eu/article/82/">Art. 82<div class="menu-item-description">Compliant AI systems which present a risk</div></a></li> <li id="menu-item-1456" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1456"><a href="https://ai-act-law.eu/article/83/">Art. 83<div class="menu-item-description">Formal non-compliance</div></a></li> <li id="menu-item-1457" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1457"><a href="https://ai-act-law.eu/article/84/">Art. 84<div class="menu-item-description">Union AI testing support structures</div></a></li> <li id="menu-item-1509" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1509"><a>Section 4<div class="menu-item-description">Remedies</div></a></li> <li id="menu-item-1458" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1458"><a href="https://ai-act-law.eu/article/85/">Art. 85<div class="menu-item-description">Right to lodge a complaint with a market surveillance authority</div></a></li> <li id="menu-item-1459" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1459"><a href="https://ai-act-law.eu/article/86/">Art. 86<div class="menu-item-description">Right to explanation of individual decision-making</div></a></li> <li id="menu-item-1460" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1460"><a href="https://ai-act-law.eu/article/87/">Art. 87<div class="menu-item-description">Reporting of infringements and protection of reporting persons</div></a></li> <li id="menu-item-1510" class="section menu-item menu-item-type-custom menu-item-object-custom menu-item-1510"><a>Section 5<div class="menu-item-description">Supervision, investigation, enforcement and monitoring in respect of providers of general-purpose AI models</div></a></li> <li id="menu-item-1461" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1461"><a href="https://ai-act-law.eu/article/88/">Art. 88<div class="menu-item-description">Enforcement of the obligations of providers of general-purpose AI models</div></a></li> <li id="menu-item-1462" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1462"><a href="https://ai-act-law.eu/article/89/">Art. 89<div class="menu-item-description">Monitoring actions</div></a></li> <li id="menu-item-1464" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1464"><a href="https://ai-act-law.eu/article/90/">Art. 90<div class="menu-item-description">Alerts of systemic risks by the scientific panel</div></a></li> <li id="menu-item-1465" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1465"><a href="https://ai-act-law.eu/article/91/">Art. 91<div class="menu-item-description">Power to request documentation and information</div></a></li> <li id="menu-item-1466" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1466"><a href="https://ai-act-law.eu/article/92/">Art. 92<div class="menu-item-description">Power to conduct evaluations</div></a></li> <li id="menu-item-1467" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1467"><a href="https://ai-act-law.eu/article/93/">Art. 93<div class="menu-item-description">Power to request measures</div></a></li> <li id="menu-item-1468" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1468"><a href="https://ai-act-law.eu/article/94/">Art. 94<div class="menu-item-description">Procedural rights of economic operators of the general-purpose AI model</div></a></li> </ul> </li> <li id="menu-item-1477" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1477"><a href="https://ai-act-law.eu/chapter/10/">Chapter 10 (Art. 95-96)<div class="menu-item-description">Codes of conduct and guidelines</div></a> <ul class="sub-menu"> <li id="menu-item-1469" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1469"><a href="https://ai-act-law.eu/article/95/">Art. 95<div class="menu-item-description">Codes of conduct for voluntary application of specific requirements</div></a></li> <li id="menu-item-1470" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1470"><a href="https://ai-act-law.eu/article/96/">Art. 96<div class="menu-item-description">Guidelines from the Commission on the implementation of this Regulation</div></a></li> </ul> </li> <li id="menu-item-1476" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1476"><a href="https://ai-act-law.eu/chapter/11/">Chapter 11 (Art. 97-98)<div class="menu-item-description">Delegation of power and committee procedure</div></a> <ul class="sub-menu"> <li id="menu-item-1471" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1471"><a href="https://ai-act-law.eu/article/97/">Art. 97<div class="menu-item-description">Exercise of the delegation</div></a></li> <li id="menu-item-1472" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1472"><a href="https://ai-act-law.eu/article/98/">Art. 98<div class="menu-item-description">Committee procedure</div></a></li> </ul> </li> <li id="menu-item-1475" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1475"><a href="https://ai-act-law.eu/chapter/12/">Chapter 12 (Art. 99-101)<div class="menu-item-description">Penalties</div></a> <ul class="sub-menu"> <li id="menu-item-1473" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1473"><a href="https://ai-act-law.eu/article/99/">Art. 99<div class="menu-item-description">Penalties</div></a></li> <li id="menu-item-1487" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1487"><a href="https://ai-act-law.eu/article/100/">Art. 100<div class="menu-item-description">Administrative fines on Union institutions, bodies, offices and agencies</div></a></li> <li id="menu-item-1479" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1479"><a href="https://ai-act-law.eu/article/101/">Art. 101<div class="menu-item-description">Fines for providers of general-purpose AI models</div></a></li> </ul> </li> <li id="menu-item-1474" class="menu-item menu-item-type-post_type menu-item-object-chapter menu-item-has-children menu-item-1474"><a href="https://ai-act-law.eu/chapter/13/">Chapter 13 (Art. 102-113)<div class="menu-item-description">Final provisions</div></a> <ul class="sub-menu"> <li id="menu-item-1480" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1480"><a href="https://ai-act-law.eu/article/102/">Art. 102<div class="menu-item-description">Amendment to Regulation (EC) No 300/2008</div></a></li> <li id="menu-item-1481" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1481"><a href="https://ai-act-law.eu/article/103/">Art. 103<div class="menu-item-description">Amendment to Regulation (EU) No 167/2013</div></a></li> <li id="menu-item-1482" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1482"><a href="https://ai-act-law.eu/article/104/">Art. 104<div class="menu-item-description">Amendment to Regulation (EU) No 168/2013</div></a></li> <li id="menu-item-1483" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1483"><a href="https://ai-act-law.eu/article/105/">Art. 105<div class="menu-item-description">Amendment to Directive 2014/90/EU</div></a></li> <li id="menu-item-1484" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1484"><a href="https://ai-act-law.eu/article/106/">Art. 106<div class="menu-item-description">Amendment to Directive (EU) 2016/797</div></a></li> <li id="menu-item-1485" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1485"><a href="https://ai-act-law.eu/article/107/">Art. 107<div class="menu-item-description">Amendment to Regulation (EU) 2018/858</div></a></li> <li id="menu-item-1486" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1486"><a href="https://ai-act-law.eu/article/108/">Art. 108<div class="menu-item-description">Amendments to Regulation (EU) 2018/1139</div></a></li> <li id="menu-item-1478" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1478"><a href="https://ai-act-law.eu/article/109/">Art. 109<div class="menu-item-description">Amendment to Regulation (EU) 2019/2144</div></a></li> <li id="menu-item-1488" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1488"><a href="https://ai-act-law.eu/article/110/">Art. 110<div class="menu-item-description">Amendment to Directive (EU) 2020/1828</div></a></li> <li id="menu-item-1489" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1489"><a href="https://ai-act-law.eu/article/111/">Art. 111<div class="menu-item-description">AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked</div></a></li> <li id="menu-item-1490" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1490"><a href="https://ai-act-law.eu/article/112/">Art. 112<div class="menu-item-description">Evaluation and review</div></a></li> <li id="menu-item-1491" class="menu-item menu-item-type-post_type menu-item-object-article menu-item-1491"><a href="https://ai-act-law.eu/article/113/">Art. 113<div class="menu-item-description">Entry into force and application</div></a></li> </ul> </li> </ul></nav></nav> </div> <div id="widget-area" class="widget-area" role="complementary"> <aside id="text-2" class="widget-1 no-widget-title widget widget_text"><h2 class="widget-title">Imprint</h2> <div class="textwidget"><p><a class="imprint" href="https://ai-act-law.eu/imprint-privacy-policy/">Imprint | Privacy Policy | Liability</a></p> </div> </aside> </div> </div> </div> <div id="content" class="site-content"> <div id="primary" class="content-area"> <main id="main" class="site-main" role="main"> <article id="post-72" class="article-en-order-number-17 post-72 article type-article status-publish hentry"> <header class="entry-header"> <h1 class="entry-title"><span class="dsgvo-number">Art. 17 AI Act </span><span class="dsgvo-title">Quality management system</span></h1> </header> <div class="entry-content"> <ol> <li><sup>1</sup>Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. <sup>2</sup>That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects: <ol> <li>a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;</li> <li>techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;</li> <li>techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;</li> <li>examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;</li> <li>technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;</li> <li>systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;</li> <li>the risk management system referred to in <a href="https://ai-act-law.eu/article/9/">Article 9</a>;</li> <li>the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with <a href="https://ai-act-law.eu/article/72/">Article 72</a>;</li> <li>procedures related to the reporting of a serious incident in accordance with <a href="https://ai-act-law.eu/article/73/">Article 73</a>;</li> <li>the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;</li> <li>systems and procedures for record-keeping of all relevant documentation and information;</li> <li>resource management, including security-of-supply related measures;</li> <li>an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.</li> </ol> </li> <li><sup>1</sup>The implementation of the aspects referred to in paragraph 1 shall be proportionate to the size of the provider’s organisation. <sup>2</sup>Providers shall, in any event, respect the degree of rigour and the level of protection required to ensure the compliance of their high-risk AI systems with this Regulation.</li> <li>Providers of high-risk AI systems that are subject to obligations regarding quality management systems or an equivalent function under relevant sectoral Union law may include the aspects listed in paragraph 1 as part of the quality management systems pursuant to that law.</li> <li><sup>1</sup>For providers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the obligation to put in place a quality management system, with the exception of paragraph 1, points (g), (h) and (i) of this Article, shall be deemed to be fulfilled by complying with the rules on internal governance arrangements or processes pursuant to the relevant Union financial services law. <sup>2</sup>To that end, any harmonised standards referred to in <a href="https://ai-act-law.eu/article/40/">Article 40</a> shall be taken into account.</li> </ol> <div 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