SGS Fimko has been officially designated as a Notified Body (NB 0598) in accordance with the EU Medical Device Regulation (MDR (EU) 2017/745) by the Finnish Medicines and Medical Devices Agency (FIMEA). This designation authorizes SGS Fimko to carry out conformity assessments of medical devices in accordance with the strict requirements of the MDR.
Scope of MDR notification
The designation by FIMEA covers the following conformity assessment procedures:
- Annex IX, Chapter I: Assessment of the Quality Management System (QMS) and technical documentation
- Annex IX, Chapter II: Evaluation of the ongoing implementation and effectiveness of the QMS
- Annex X: Product verification
- Annex XI, Parts A and B: Product and QMS verification
This comprehensive designation covers nearly all categories of active medical devices, as well as numerous non-active, non-implantable medical devices up to and including risk class IIb. Furthermore, the Notified Body is recognized for medical device software up to class III.
SGS Germany – Your connection to Notified Body SGS Fimko
SGS Germany offers complete MDR certification services in direct collaboration with SGS Fimko (CE 0598). You benefit from:
- Personalized support from local experts in Germany
- International expertise thanks to the global SGS network
- Efficient, transparent and fast certification processes
- Many years of experience in the field of medical device certification
For more information about the designation of SGS Fimko, please visit the website of the European Commission.
Contact
Armin Hudetz
t: +49 89 78 74 75-133
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Customer Service Team
t: +49 89 78 74 75-222
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