{"id":6257,"date":"2026-09-23T11:52:30","date_gmt":"2026-09-23T08:52:30","guid":{"rendered":"https:\/\/aesinn.com\/muayene-periyodik-kontrol\/mekanik-ekipman-muayeneleri\/makine-tuzugunde-oz-beyandan-onaylanmis-kurulusa-yuksek-riskli-ek-i-makinelerde-uygunluk-degerlendirmesi-yolunu-nasil-belirlersiniz\/"},"modified":"2026-09-28T14:19:11","modified_gmt":"2026-09-28T11:19:11","slug":"makine-tuzugunde-oz-beyandan-onaylanmis-kurulusa-yuksek-riskli-ek-i-makinelerde-uygunluk-degerlendirmesi-yolunu-nasil-belirlersiniz","status":"publish","type":"page","link":"https:\/\/aesinn.com\/en\/muayene-periyodik-kontrol\/mekanik-ekipman-muayeneleri\/makine-tuzugunde-oz-beyandan-onaylanmis-kurulusa-yuksek-riskli-ek-i-makinelerde-uygunluk-degerlendirmesi-yolunu-nasil-belirlersiniz\/","title":{"rendered":"From Self-Declaration to Notified Body in the Machinery Regulation: How Do You Determine the Conformity Assessment Path for High-Risk (Annex I) Machinery?"},"content":{"rendered":"<h2 class=\"wp-block-heading\">Scope of this Page: A Single Decision<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This information sheet focuses on a single, narrow question: Does your machine fall under the new Machinery Regulations Annex I list, and should you assess its conformity through self-declaration or with the involvement of a Notified Body, and how do you make this decision? The aim is to provide a roadmap to guide you towards the correct conformity assessment path.<\/p>\n\n\n\n<div class=\"aes-ortak-notu\" style=\"border-left:4px solid #CE1A1A;background:#f6f6f6;padding:14px 18px;margin:18px 0 22px 0;font-size:15px;line-height:1.6;color:#222;\"><strong>Service note:<\/strong> AES Innovation carries out the EU compliance work described on this page (PPWR, digital product passport, CBAM, etc.) in collaboration with expert solution partners; it does not provide these services directly. These activities are outside the scope of our accreditation (EU-0631-M).<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">The general introduction to the Machinery Regulations, digital directives, artificial intelligence, cybersecurity, and all innovations are covered in our general guide; technical file and risk assessment consultancy are described on our relevant services page. Here, we are only examining the decision on the conformity assessment path, namely self-declaration or Notified Body.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>Focus: selection of the conformity assessment method (self-declaration or Notified Body).<\/li>\n\n\n<li>For an introduction to the general bylaws and all the latest news: see our general guide.<\/li>\n\n\n<li>For technical documentation and risk assessment consultancy: please see our relevant services page.<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Why it&#039;s changing: From 2006\/42\/EC (EU) to 2023\/1230<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The new Machinery Regulation (EU) 2023\/1230 replaces the existing Machinery Directive 2006\/42\/EC and will come into full application on 20 January 2027. The regulation is directly binding; unlike a directive, it does not need to be transposed into national legislation and the same text applies across the entire European Union market.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The most significant change in terms of conformity assessment is the narrowing or complete closure of the self-declaration pathway for certain categories of machinery defined as high-risk. Therefore, a machine placed on the market with self-certification under the 2006\/42\/EC period may fall into a category requiring third-party assessment under the new regulation. The decision now depends more strongly on the type of machinery and its classification in Annex I.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>(EU) 2023\/1230 full implementation date: 20 January 2027.<\/li>\n\n\n<li>The regulations are directly binding; no national transposition is required.<\/li>\n\n\n<li>Key effect: narrowing of the self-disclosure pathway in high-risk categories.<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Appendix I Logic: Mandatory Third-Party or Conditional Self-Declaration?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Annex I addresses high-risk machinery in two parts within a reasonable framework. One part covers machinery where the involvement of a Notified Body is mandatory; for these machines, third-party conformity assessment is required under all circumstances, and self-declaration is not an option.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The other part is conditional. For these machines, self-declaration based on internal production control may be possible if the relevant harmonized standards are fully complied with. However, if harmonized standards do not exist, are not fully complied with, or are only partially applied, then the involvement of a Notified Body becomes necessary for these machines as well. The definitive category list and which part each machine belongs to should be determined based on the current text of Annex I and the assessment of an authorized engineer; the examples given on this page are general in nature and do not constitute an item-by-item classification.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>Mandatory third-party: In some categories, a Notified Body is required in all cases; self-declaration is not necessary.<\/li>\n\n\n<li>Conditional approach: self-declaration may be possible if the harmonized standard is fully complied with.<\/li>\n\n\n<li>If there is incomplete compliance or the standard is lacking, a Notified Body becomes required.<\/li>\n\n\n<li>The current Annex I list and assessment by qualified engineers are essential for accurate classification.<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Decision Tree: Which Path Will Your Machine Take?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The following steps outline a sequence of decisions you can follow to determine the conformity assessment path. Each step opens the door to the next; if at any point you are directed towards the Notified Body path, you should base your decision on that path before proceeding to the next steps.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>Step 1: Is your machine included in the current Annex I list? If not, the general conformity assessment and self-declaration provisions of the regulation may apply.<\/li>\n\n\n<li>Step 2: Does your machine fall under the part of Annex I that requires mandatory third-party assessment? If yes, participation by a Notified Body is mandatory; self-declaration is not possible.<\/li>\n\n\n<li>Step 3: Is your machine a conditional part of Annex I? If so, are all relevant harmonized standards available and do you fully comply with them?<\/li>\n\n\n<li>Step 4: If full compliance with standards is achieved, the self-declaration method based on internal production control can be evaluated; if full compliance is not achieved, the Notified Body method is considered.<\/li>\n\n\n<li>Step 5: Does your machine have software that performs security functions, self-improving components, or AI-like behavior? If so, the self-declaration path may be closed for these categories (see the next section).<\/li>\n\n\n<li>Classification decisions at each step are machine-specific and require expert engineering assessment.<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Software and AI-driven Machines: Where Self-Reporting Closes<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">One of the most notable innovations in the new regulations is that software performing a security function is also considered a security component. This means that security-critical software is subject to compliance assessment just like a physical security component.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this context, some machines that are self-improving or exhibiting AI behavior have been classified as high-risk under Annex I. For machines in these categories, the self-declaration pathway is closed, and the involvement of a Notified Body becomes mandatory. Compared to 2006\/42\/EC, this change is one of the most significant differences directly affecting the conformity assessment pathway and is a topic that should be checked early in your decision tree.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>Software that performs security functions is now considered a security component.<\/li>\n\n\n<li>Some self-improving machines or machines with artificial intelligence behavior are classified as high-risk under Annex I.<\/li>\n\n\n<li>Self-declaration is not possible in these categories; a Notified Body is mandatory.<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Harmonized Standard Gap and Conformity Assumption<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The conditional self-declaration method relies on the existence and full compliance with the relevant harmonized standards. It provides the presumption of conformity, meaning that the machine is considered to conform to the relevant requirements when these standards are applied. The Commission submitted a standardization request to CEN and CENELEC on 20 January 2025 regarding the new regulation; publication of the references to the new harmonized standards in the Official Gazette is expected.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">However, the list of standards may not be complete by January 20, 2027, creating a risk of a temporary gap in the presumption of conformity. Machines that comply with current Machinery Directive standards may, in most cases, retain the presumption; nevertheless, it is the responsibility of the manufacturer and the authorized engineer to verify, clause by clause, which standards are still considered applicable. Since exact publication dates are not yet determined, flexibility in planning is recommended.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>The presumption of conformity is established by full compliance with harmonized standards.<\/li>\n\n\n<li>The Commission submitted a standardization request to CEN and CENELEC on January 20, 2025.<\/li>\n\n\n<li>The list may not be complete by the beginning of 2027; there is a risk of a temporary gap in assumptions.<\/li>\n\n\n<li>Verifying which standard is considered applicable is the responsibility of the manufacturer and the authorized engineer.<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Early Planning for Turkish Machinery Exporters<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The most tangible impact for Turkish machinery exporters is the narrowing of the self-certification space. Even if a machine in a high-risk category fully complies with the harmonized standard, the mandatory part still requires the involvement of a Notified Body. Since the capacity and assessment schedule of Notified Bodies may be limited, determining the conformity assessment path early reduces timing risks.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Since the CE mark is also valid in the Turkish domestic market within the framework of the Customs Union, this decision is important not only for export but also for supply to the domestic market. Evaluating your machine&#039;s Annex I classification and the necessary process today will ensure you are prepared for the 2027 transition.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li>The self-certification space is shrinking in high-risk categories.<\/li>\n\n\n<li>The capacity and schedule of the Notified Body may create scheduling risks.<\/li>\n\n\n<li>The CE mark is also valid within the Customs Union and in the Turkish domestic market.<\/li>\n\n\n<li>Early classification will prevent delays in the 2027 transition.<\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Information Note<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This content is for informational purposes only. AES is not a Notified Body or certification body; it does not issue CE certificates for machinery, nor does it perform third-party conformity assessments or Notified Body inspections. Services related to machinery are in the nature of consultancy and technical assessment by qualified engineers.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AES&#039;s T\u00dcRKAK accreditation is only within the scope of 6.1 Electrical Installation inspection. The conformity assessment method and Annex I classification must be evaluated separately for each machine, taking into account the machine-specific conditions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Related Services and Content<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n\n<li><a href=\"https:\/\/aesinn.com\/en\/muayene-periyodik-kontrol\/mekanik-ekipman-muayeneleri\/makine-ce-uygunlugu-risk-degerlendirmesi-ve-teknik-dosya-danismanligi\/\">Machine CE Conformity, Risk Assessment and Technical File Consulting<\/a><\/li>\n\n\n<li><a href=\"https:\/\/aesinn.com\/en\/yeni-ab-makine-tuzugu-ab-2023-1230-turk-ureticiler-icin-2027-rehberi\/\">New EU Machinery Regulation (EU) 2023\/1230: Guidance for Turkish Manufacturers until 2027<\/a><\/li>\n\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Frequently Asked Questions<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">How do I decide whether my machine will be assessed by self-declaration or by a Notified Body?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">First, we check whether your machine is currently on the Annex I list. If it is on the mandatory part of Annex I, participation of a Notified Body is required. If it is on the conditional part, self-declaration based on internal production control may be considered if there is full compliance with the relevant harmonized standards; otherwise, participation of a Notified Body is required. This decision is machine-specific and requires assessment by a qualified engineer.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">If I fully comply with the harmonized standard, is the self-declaration option always open to me?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">No. Full compliance with the standard only opens the way for self-declaration for machines in the conditional part of Annex I. For machines in the mandatory third-party part of Annex I, participation by a Notified Body is mandatory even if you fully comply with the standard, and there is no way for self-declaration.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Which path will my machine, which contains artificial intelligence or self-improving software, take?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Software performing security functions is considered a security component under the new regulations. Certain self-improving or AI-behaved machines are classified as high-risk under Annex I, and self-declaration is no longer possible in these categories; participation by a Notified Body becomes mandatory. Whether your machine falls within this scope will be determined according to the current text of Annex I and the assessment of an authorized engineer.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Are cybersecurity regulations being postponed until 2027?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">It cannot be said that it has been postponed. Industry associations (CEMA, CECE, CECIMO, EGMF, FEM) have jointly requested that the alignment of cybersecurity provisions with the CRA be postponed to a later date in early 2026; the workers&#039; side has opposed this request. The Commission&#039;s decision on this matter has not yet been made or confirmed, so the issue is pending. Planning your conformity assessment decision based on a full implementation date of January 20, 2027, is the safest approach.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What should I do if the harmonized list of standards is incomplete at the beginning of 2027?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The incompleteness of the standards list may create a risk of a temporary gap in the presumption of conformity. Machines that comply with current Machinery Directive standards may, in most cases, maintain the presumption; however, it is the responsibility of the manufacturer and the authorized engineer to verify, clause by clause, which standard is considered applicable. Due to this uncertainty, it is recommended that you maintain flexibility in your planning.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">What service does AES provide during this process?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">AES is not a Notified Body or certification body; it does not issue CE certificates for machinery and does not perform third-party conformity assessments. Services related to machinery are in the nature of consultancy and technical assessment by authorized engineers. AES&#039;s T\u00dcRKAK accreditation is only for the scope of 6.1 Electrical Installation inspection.<\/p>","protected":false},"excerpt":{"rendered":"<p>Makine T\u00fcz\u00fc\u011f\u00fc (EU) 2023\/1230, hangi makinenin \u00f6z-beyanla, hangisinin Onaylanm\u0131\u015f Kurulu\u015f (Notified Body) kat\u0131l\u0131m\u0131yla de\u011ferlendirilece\u011fini yeniden \u00e7iziyor. Bu bilgilendirme, makinenizin do\u011fru uygunluk de\u011ferlendirme yolunu ad\u0131m ad\u0131m belirlemenize yard\u0131mc\u0131 olur.<\/p>","protected":false},"author":1,"featured_media":6260,"parent":4099,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kadence_starter_templates_imported_post":false,"_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","slim_seo":{"title":"Annex I Machinery: Self-Declaration or Notified Body?","description":"Is self-declaration or a Notified Body required under Machinery Regulation (EU) 2023\/1230? Annex I decision-tree information for high-risk machinery."},"_pplb_hide_from_list":false,"footnotes":""},"class_list":["post-6257","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":["https:\/\/aesinn.com\/wp-content\/uploads\/makine-eki-nb-aes-kart-1024x1024.png",1024,1024,true],"author_info":{"display_name":"Emre Metin","author_link":"https:\/\/aesinn.com\/en\/author\/yonetim\/"},"comment_info":"","_hostinger_reach_plugin_has_subscription_block":false,"_hostinger_reach_plugin_is_elementor":false,"_links":{"self":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/6257","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/comments?post=6257"}],"version-history":[{"count":3,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/6257\/revisions"}],"predecessor-version":[{"id":6327,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/6257\/revisions\/6327"}],"up":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/pages\/4099"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/media\/6260"}],"wp:attachment":[{"href":"https:\/\/aesinn.com\/en\/wp-json\/wp\/v2\/media?parent=6257"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}