SGS Granted Notified Body Status under EU IVD Regulation
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.
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.