{"id":3313,"date":"2025-06-10T15:42:35","date_gmt":"2025-06-10T12:12:35","guid":{"rendered":"https:\/\/iranhealth.org\/en\/?p=3313"},"modified":"2025-06-15T15:46:01","modified_gmt":"2025-06-15T12:16:01","slug":"ce-certificate-the-key-to-accessing-more-than-70-of-global-markets","status":"publish","type":"post","link":"https:\/\/iranhealth.org\/en\/ce-certificate-the-key-to-accessing-more-than-70-of-global-markets\/","title":{"rendered":"CE Certificate: The Key to Accessing More Than 70% of Global Markets"},"content":{"rendered":"\t\t
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CE Certificate: TheKey to Accessing More Than 70% of Global Markets<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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June 10, 2025 \u2013 Zahra Akbari, CEO of Ayandeh\nInternational Quality Assessment, emphasized in a specialized panel on CE\ncertification essentials that the CE mark\u2014short for Conformit\u00e9 Europ\u00e9enne<\/em>\u2014is\nnot merely an optional label but a mandatory license for entry into\ninternational markets. Currently, over 70% of countries worldwide require CE\ncertification for imported products, making it a critical step for any\nmanufacturer aiming for global expansion.<\/p>

Akbari explained that the CE certification process\ninvolves several crucial steps, starting with registration in the official\nEuropean Union database, known as EUDAMED. Without this registration, companies\ncannot even request quotes from notified bodies for certification. This step\nincludes registering the manufacturer, products, and European representative.<\/p>

She highlighted that manufacturers do not need to have\na physical office in the European Union; however, they must appoint a legally\nregistered European representative, who acts as a quality guarantor. Under the\nnew regulations, this representative must be a registered legal entity with an\nSRN (Single Registration Number), which must also be displayed on product\nlabels.<\/p>

Preparing comprehensive technical documentation is\nanother essential requirement. No notified body will issue a CE certificate\nwithout this documentation, which must be structured according to the latest\nMDR guidelines. For most product classes, the evaluation must be conducted by a\nnotified body, except for lower-risk categories such as Class I or IVD Class A,\nwhere self-declaration is permitted after documentation and registration.<\/p>

Akbari also stressed the importance of correctly\nidentifying the product\u2019s risk class under MDR regulations, which consider\nfactors such as product type, intended use, duration of patient contact,\ninvasiveness, application site, and associated risks. Misclassification can\nresult in delays or rejection of the certification application.<\/p>

Additionally, companies must appoint a PRRC (Person\nResponsible for Regulatory Compliance) in Europe, who must have at least two\nyears of experience in the medical device sector, expertise in Quality\nManagement Systems (QMS), and full familiarity with MDR requirements.<\/p>

Once all requirements are met, including registration\nand documentation uploads, the CE certificate is issued and published on the EU\nportal. Akbari concluded that using specialized consultancy services can help\nIranian manufacturers streamline the process, which typically takes two to\nthree months if all prerequisites\u2014especially the SRN\u2014are in place.<\/p>

Ultimately, she noted that relying on outdated\ndocumentation or local regulatory approvals is insufficient. Only full\ncompliance with MDR and proper registration in EU systems can secure the CE\nmark and open the door to global markets.<\/p>

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CE Certificate: TheKey to Accessing More Than 70% of Global Markets June 10, 2025 \u2013 … <\/i>Read More<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[102,82],"class_list":["post-3313","post","type-post","status-publish","format-standard","hentry","category-news","tag-2025-jun-10","tag-iranhealth2025"],"yoast_head":"\nCE Certificate: The Key to Accessing More Than 70% of Global Markets - Iranhealth International Exhibition<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/iranhealth.org\/en\/ce-certificate-the-key-to-accessing-more-than-70-of-global-markets\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CE Certificate: The Key to Accessing More Than 70% of Global Markets\" \/>\n<meta property=\"og:description\" content=\"CE Certificate: TheKey to Accessing More Than 70% of Global Markets June 10, 2025 \u2013 ... 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