SGS Belgium Designated as EU Notified Body for In Vitro Diagnostic Medical Devices

SGS Belgium Designated as EU Notified Body for In Vitro Diagnostic Medical Devices

(IN BRIEF) SGS Belgium NV has been designated as a Notified Body under the EU’s In Vitro Diagnostic Medical Device Regulation (IVDR), expanding Europe’s limited capacity for regulatory assessments. Approved by the European Commission and Belgian authorities, the Antwerp-based facility (NB 1639) will help medical device manufacturers meet CE marking requirements more efficiently. SGS also holds UKCA approval, enabling it to serve both EU and UK markets. With deep expertise and a growing team, SGS is poised to guide the industry through IVDR compliance, offering certification, auditing, and regulatory support through its global network.

(PRESS RELEASE) GENEVA, 24-Apr-2025 — /EuropaWire/ — SGS Belgium NV has been officially designated as a Notified Body (NB 1639) under the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR – EU 2017/746). This milestone, confirmed by the European Commission and the Belgian Competent Authority (FAGG/AFMPS) on April 23, 2025, reinforces SGS’s role in safeguarding public health through stringent evaluation of diagnostic medical devices.

Operating from its Antwerp location, SGS Belgium now joins a select group of organizations authorized to carry out conformity assessments under the IVDR framework. The regulation was introduced to ensure that in vitro diagnostic medical devices (IVDs) marketed in the EU meet enhanced safety and performance standards, ultimately improving patient care.

The new designation comes at a critical time, as manufacturers face bottlenecks due to limited Notified Body availability across Europe. SGS’s team of seasoned experts in diagnostics and clinical laboratories aims to alleviate these delays by offering efficient certification pathways to CE marking under IVDR.

“We are proud to be recognized as a Notified Body under the EU IVDR,” said Geofrey De Visscher, Head of SGS NB 1639. “Our expanding team is committed to supporting the industry through the complexities of this demanding regulation and ensuring timely market access for high-quality diagnostics.”

SGS is also distinguished by its dual regulatory capabilities, holding approvals under both the EU IVDR and the UK Conformity Assessed (UKCA) scheme. This dual designation uniquely positions the company to assist clients with compliance needs across both EU and UK markets.

Listed on the European Commission’s NANDO database, SGS NB 1639 is part of a global network offering an array of medical device regulatory services. These include EU MDR certification, ISO 13485 audits, and participation in the Medical Device Single Audit Program (MDSAP), making SGS a comprehensive partner in regulatory compliance.

About SGS

SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.

Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.

SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).

Media Contact:

Geofrey De Visscher
Head of Notified Body 1639
Business Assurance
t: +32 474 31 23 46

SOURCE: SGS