We are thrilled to announce that SGS Belgium NV (Notified Body 1639) has been designated by the European Commission and Belgian Competent Authority (FAGG/AFMPS) under the In Vitro Diagnostic Medical Device Regulation (EU 2017/746, IVDR).
Under the IVDR, a broader range of devices requires conformity assessment and certification by an NB. Limited NB capacity has emerged as a key challenge in implementing the regulation. We have set out to address this shortage by assembling a team of IVD industry and clinical laboratory experts ready to support your organization’s IVDR mission.
Geofrey De Visscher, Head of SGS NB 1639, welcomed the news of designation: “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.”
We have 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 our global network of national offices look forward to supporting your IVDR compliance journey.
The EU IVDR replaces the In Vitro Diagnostic Medical Device Directive (IVDD). The IVDR regulates in vitro diagnostic medical devices placed on the EU market. It aims to enhance the quality of patient care by safeguarding device safety and performance while providing a robust and transparent legislative framework for manufacturers and regulators. Compared to the IVDD, the IVDR has new obligations for device manufacturers. The transitional period during which the new rules must be implemented is ongoing.
The official notice of our designation can be accessed here.
For more information, visit SGS’s Medical Devices Regulatory Compliance portfolio or contact:
Geofrey De Visscher
Head of Notified Body 1639
Business Assurance
t: +32 474 31 23 46
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).
7, M. Eminescu Street,
Republic of Moldova,
Chisinau, Moldova