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SGS Granted Notified Body Status under EU IVD Regulation

October 21, 2025

We are pleased to announce that SGS Fimko Oy (SGS), in Finland has officially been designated as a Notified Body under the European Union (EU) Regulation (EU) 2017/746 – 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 in the European Nando database, identification number 0598.

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.

“Being granted Notified Body status under the IVDR strengthens our position as a leading conformity assessment body both in Finland and internationally,” says Markus Ahvenus, Certification Director at SGS in Finland. “We are proud to offer our customers comprehensive assessment and certification services that support product access to the European market.”

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.

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.

For further information, please contact:

Mari Levula
Head of IVDR Notified Body
SGS Fimko Oy
t: +358 44 744 1308

About SGS

SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.

Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.

SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).

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