The European Commission has officially recognized SGS Fimko Oy as a Notified Body (NB 0598) under the EU In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. This designation authorizes SGS Fimko Oy to assess the conformity of in vitro diagnostics within its defined scope of competence in accordance with the IVDR.
The IVDR has been in force since May 2017 and fully applicable since 26 May 2022. It sets high requirements for product safety, performance evaluation, and clinical evidence. The SGS Group reliably supports both national and international companies in a challenging regulatory environment. Our customers benefit from comprehensive assessment and certification services, which enable safe and efficient market access in Europe.
Scope of IVDR designation
The scope of SGS’s competence covers conformity assessment according to the following IVDR annexes:
- Annex IX, Chapter I: Conformity assessment based on a quality management system (QMS)
- Annex IX, Chapter II: Conformity assessment based on assessment of the technical documentation
- Annex X: Conformity assessment based on type examination
- Annex XI: Conformity assessment based on production quality assurance
This comprehensive designation covers almost all IVD products.
SGS Germany – your point of contact to the Notified Body SGS Fimko
In direct collaboration with SGS Fimko, the SGS Group Germany offers comprehensive IVDR certification services. Benefit from:
- Secure 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 customers through SGS Germany GmbH
- Efficient, transparent, and fast certification processes
Further information on the designation of SGS Fimko can be found on the European Commission’s website.
Contact
Armin Hudetz
t: +49 89 787 475-133
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Customer Service Team
t: +49 89 787 475-222
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