SGS Fimko receives additional MDR designations – Service portfolio for medical device manufacturers significantly expanded

Our Notified Body, SGS Fimko (CE 0598), significantly expanded the scope of its designation as of February 2025. This means that SGS can now offer certifications for almost all active medical device groups, as well as for numerous non-active medical device groups for non-implantable medical devices.

The new MDR codes, in accordance with Regulation (EU) 2017/745 for medical devices, have already been published in the EU Commission's NANDO database, significantly expanding SGS's accredited certification portfolio for medical devices.

For medical device manufacturers, this means:

  • Even more comprehensive accredited certification services from SGS
  • A reliable partner for start-ups as well as small and medium-sized medical device manufacturers
  • Direct contact and personal support for efficient MDR certification with SGS

The full list of SGS Fimko designations can be found on the European Commission website.

We look forward to accompanying you into the EU market with our Notified Body, SGS Fimko, as a competent and experienced certification institute!

Contact us directly by e-mail or telephone if you have any questions, are just starting your certification process, or are considering changing your Notified Body.

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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