SGS Designated as Notified Body Under EU IVDR

SGS, a testing, inspection, and certification company, announced that SGS Belgium NV has been designated as a Notified Body (NB) under the EU’s In Vitro Diagnostic Medical Device Regulation (EU 2017/746, IVDR).

The Antwerp-based facility (NB 1639) gained approval from the European Commission and Belgian Competent Authority (FAGG/AFMPS) today. EU IVDR seeks to boost quality of patient care by safeguarding device safety and performance through more regulation of IVD devices on the EU market.

Limited NB capacity is emerging as a challenge in Europe to implementing the new regulation. SGS’ team of IVD industry and clinical lab experts aim to lessen the pressure on device makers looking for CE marking for their IVD devices.

SGS has decades of expertise in medical device regulatory compliance, providing services including EU Medical Device Regulation (MDR), ISO 13485, and Medical Device Single Audit Program (MDSAP) solutions.

“Thanks to the team’s hard work, we are delighted to become a designated NB under the EU IVDR,” said Geofrey De Visscher, head of SGS NB 1639. “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.”