{"id":5162,"date":"2025-10-22T09:21:13","date_gmt":"2025-10-22T06:21:13","guid":{"rendered":"https:\/\/teknologiateollisuus.fi\/healthtech\/?p=5162"},"modified":"2025-10-22T09:21:13","modified_gmt":"2025-10-22T06:21:13","slug":"sgs-granted-notified-body-status-under-eu-ivd-regulation","status":"publish","type":"post","link":"https:\/\/teknologiateollisuus.fi\/healthtech\/sgs-granted-notified-body-status-under-eu-ivd-regulation\/","title":{"rendered":"SGS Granted Notified Body Status under EU IVD Regulation"},"content":{"rendered":"\n

SGS Fimko Oy (SGS), in Finland has officially been designated as a Notified Body under the European Union (EU) Regulation (EU) 2017\/746 \u2013 In Vitro Diagnostic Medical Devices Regulation (IVDR).<\/h4>\n\n\n\n

This designation enables the assessment of in vitro diagnostic medical devices for conformity with the IVDR. The full scope of the designation can be viewed in the\u00a0European Nando database<\/a>.<\/p>\n\n\n\n

\n
\n

SGS Fimko Oy identification number is 0598<\/p>\n<\/blockquote>\n<\/div>\n\n\n\n

The IVDR came into force in May 2017 and has been fully applicable since May 26, 2022, introducing stricter requirements for product safety, performance and clinical evaluation. Achieving Notified Body status reflects a high level of expertise and the ability to operate in a demanding regulatory environment.<\/p>\n\n\n\n

\u201cBeing granted Notified Body status under the IVDR strengthens our position as a leading conformity assessment body both in Finland and internationally,\u201d says Markus Ahvenus<\/strong>, Certification Director at SGS in Finland. \u201cWe are proud to offer our customers comprehensive assessment and certification services that support product access to the European market.\u201d<\/p>\n\n\n\n

This milestone supports our broader strategy to expand services in the medical and in vitro diagnostic device sector. Integration across the global network ensures customers benefit from extensive expertise and high-quality services across all major markets.<\/p>\n\n\n\n

SGS now holds 11 Notified Body designations in Finland across multiple regulations, including medical devices, electromagnetic compatibility (EMC) and radio equipment. In addition, FINAS-accredited quality system certification services are available. Explore the full range of services on the FINAS Accreditation Service website<\/a>.<\/p>\n\n\n\n

<\/p>\n\n\n\n

\n
Read more: SGS Fimko Oy web pages<\/a><\/div>\n<\/div>\n\n\n\n
\n

In Finland we have now three IVDR notified bodies:<\/h2>\n\n\n\n

Eurofins Electric & Electronics Finland Oy<\/strong> – Notified Body nro 0537<\/a><\/h4>\n\n\n\n

Sertio Oy<\/strong> – Notified Body nro 3018<\/a><\/h4>\n\n\n\n

SGS Fimko Oy<\/strong> – Notified Body nro 0598<\/a><\/h4>\n<\/div>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

SGS Fimko Oy (SGS), in Finland has officially been designated as a Notified Body under the European Union (EU) Regulation (EU) 2017\/746 \u2013 In Vitro Diagnostic Medical Devices Regulation (IVDR). This designation enables the assessment of in vitro diagnostic medical devices for conformity with the IVDR. The full scope of the designation can be viewed […]<\/p>\n","protected":false},"author":16,"featured_media":5160,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"2384,2044,2398,2109,934,729","_relevanssi_noindex_reason":"","inline_featured_image":false,"footnotes":""},"categories":[14],"tags":[162],"em_industry":[],"em_theme":[136,53,48],"class_list":["post-5162","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uutinen","tag-in-english","em_theme-jasenyritys","em_theme-laboratoriodiagnostiikka","em_theme-lainsaadanto"],"acf":[],"yoast_head":"\nSGS Granted 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