SGS Designated as a Notified Body Under EU IVDR
SGS, the world’s leading testing, inspection and certification company, is delighted to announce the designation of SGS Belgium NV as a Notified Body (NB) under the EU’s In Vitro Diagnostic Medical Device Regulation (EU 2017/746, IVDR).
The Antwerp-based facility (Notified Body 1639) gained approval from the European Commission and Belgian Competent Authority (FAGG/AFMPS) on April 23, 2025.
EU IVDR aims to enhance the quality of patient care by safeguarding device safety and performance through the greater regulation of in vitro diagnostic medical devices placed on the EU market.
With limited NB capacity in Europe emerging as a key challenge to implementing the new regulation, SGS’s new team of IVD industry and clinical laboratory experts aims to ease the pressure on device manufacturers seeking CE marking for their in vitro diagnostic medical devices.
Geofrey De Visscher, Head of SGS NB 1639, said: “Thanks to the team’s hard work, we are delighted to become a designated NB under the EU IVDR.
“We are excited to work with the industry to drive the implementation of this demanding regulation. With our existing approvals under the UK Conformity Assessed (UKCA) scheme, we are one of the few companies capable of providing certification services for medical devices across the whole of Europe.
“Our team continues to rapidly expand to ensure that we can quickly serve the certification needs of our customers.”
SGS Belgium NV is now listed in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database here.
SGS has decades of expertise in medical device regulatory compliance, providing a multitude of services, including EU Medical Device Regulation (MDR), ISO 13485 and Medical Device Single Audit Program (MDSAP) solutions. SGS NB 1639 and its global network of national offices are committed to supporting the industry on its IVDR compliance journey.
For more information, visit https://www.sgs.com/en/services/in-vitro-diagnostic-medical-device-regulation-ivdr-certification-services.
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