SGS Belgium NV Receives Designation as Notified Body under EU IVDR to Support In Vitro Diagnostic Device Compliance

SGS Belgium NV Receives Designation as Notified Body under EU IVDR to Support In Vitro Diagnostic Device Compliance

(IN BRIEF) SGS Belgium NV has been officially designated by the European Commission and Belgian Competent Authority as a Notified Body (NB) under the In Vitro Diagnostic Medical Device Regulation (IVDR), EU 2017/746. This milestone enhances SGS’s ability to support companies in achieving compliance with the new regulation, which aims to improve the safety and performance of in vitro diagnostic devices across Europe. SGS, with its expertise in medical device regulatory compliance, is well-positioned to provide certification services throughout Europe, addressing the increasing demand for NB capacity under the IVDR.

(PRESS RELEASE) GENEVA, 1-May-2025 — /EuropaWire/ — SGS Belgium NV (Notified Body 1639) has received a prestigious designation from the European Commission and the Belgian Competent Authority (FAGG/AFMPS) under the In Vitro Diagnostic Medical Device Regulation (EU 2017/746, IVDR), a critical step in advancing regulatory compliance for in vitro diagnostic (IVD) devices in Europe.

The In Vitro Diagnostic Medical Device Regulation (IVDR) expands the scope of regulatory requirements for IVD devices, requiring a broader range of products to undergo conformity assessment and certification by a Notified Body (NB). One of the challenges that has emerged in implementing the regulation is the limited availability of Notified Body capacity. SGS Belgium NV is stepping up to address this challenge by assembling a team of experts in the IVD industry and clinical laboratories, ready to assist organizations in achieving compliance under the new regulation.

Geofrey De Visscher, Head of SGS NB 1639, expressed his enthusiasm about the designation: “We are proud of our team’s hard work that has led us to become a designated Notified Body under the EU IVDR. We are eager to collaborate with the industry to drive forward the implementation of this demanding regulation. With our existing approvals under the UK Conformity Assessed (UKCA) scheme, we are uniquely positioned to provide certification services for medical devices across Europe.”

SGS has decades of experience in medical device regulatory compliance, offering a wide range of services, including the EU Medical Device Regulation (MDR), ISO 13485, and the Medical Device Single Audit Program (MDSAP). SGS NB 1639, supported by a global network of offices, looks forward to assisting companies in navigating the IVDR compliance process.

The EU IVDR replaces the previous In Vitro Diagnostic Medical Device Directive (IVDD) and regulates IVD devices on the European market. The new regulation aims to improve patient care by ensuring higher safety and performance standards for medical devices. With more stringent obligations for manufacturers compared to the IVDD, the IVDR introduces a transitional period for full implementation.

The official announcement of SGS Belgium’s designation can be accessed through the link provided.

About SGS

SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,700 laboratories and business facilities across 119 countries, supported by a team of 99,250 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, safety and compliance.

Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and sustainability, 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 CH0002497458, 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