The SGS Group has reached an important milestone: The European Commission has officially designated SGS Fimko Oy as a Notified Body under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746. SGS Fimko Oy is now authorized to assess the conformity of in vitro diagnostic medical devices within its designated scope of competence under the IVDR.
- Scope of SGS Fimko’s competence: European Union NANDO database
- Notified Body identification number: 0598
The IVD Regulation came into force in May 2017 and has been fully applicable since May 26, 2022. The regulation introduces stricter requirements for product safety, performance, and clinical evaluation. Achieving Notified Body status demonstrates SGS Fimko’s expertise and capability to support customers operating in a demanding regulatory environment. National and international clients benefit from comprehensive assessment and certification services, facilitating access to the European market.
SGS – your global partner for IVDR certifications
This designation is part of SGS Group’s strategy to expand its services in the field of medical devices and in vitro diagnostics. As a member of the global SGS network, SGS Fimko Oy enables customers to benefit from:
- Extensive expertise across all major markets
- High-quality testing and certification services
- 11 Notified Body designations under various regulations, including medical devices, electromagnetic compatibility, and radio equipment.
For German clients, IVDR certification projects can be handled directly through SGS Germany GmbH. Close collaboration with local auditors ensures an efficient and practical certification process.
SGS Fimko Oy also offers FINAS-accredited quality system certification services. You can explore our range of services on the FINAS (Finnish Accreditation Service) website.
Your benefits at a glance
- Ensure market access to the European market for in vitro diagnostics
- Support from an international network of experts
- Certification according to the highest standards
- Local handling for German clients via SGS Germany GmbH
Tap into our expertise and global network to ensure the conformity of your products under IVDR.
Contact
Vasily Kalakutskiy
t: +49 89 787 475-137
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Customer Service Team
t: +49 89 787 475-222
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