Appointment of a new Belgian Notified Body EU MDR

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SGS Belgium has been designated as a notified body under the EU Medical Device Regulation. It is the first testing and certification organization to be appointed in Belgium and the 25th in the EU under the MDR. There are bottlenecks predicted for notified body testing services in 2023 and 2024 as MDR grace period deadline of 26 May 2024 looms. The medtech industry welcomes every additional new designation which will increase overall notified body capacity. There has also been much emphasis placed on the importance of having testing carried out earlier.

As the MDR grace period deadline of 26 May 2024 draws ever closer, the medtech industry welcomes every additional new designation which will increase overall notified body capacity. This is because there are bottlenecks predicted for notified body testing services in 2023 and 2024, due to the large volume of devices which have benefited from it. So far, much emphasis has been placed on how an earlier testing phase can mitigate these bottlenecks.

SGS Belgium’s testing services covers a wide range of products. It can test active devices, non-active non-implantables, and long-term surgically invasive devices. It also specializes in custom made implantable devices, devices manufactured with electronics components, and products manufactured with animal tissue or cells.

The EU has an MDR notification body in each country, with Italy having 6, Germany 6, the Netherlands 3, Finland 2 and one apiece in Croatia, France, Hungary, Ireland, Norway and Sweden.

Under the IVDR (In Vitro Diagnosis Device Regalation), there are 3 testing labs in Germany, 2 in Netherlands and 1 in France.

The Belgian government has announced that they will designate SGS Belgium as a notified body under the new Medical Devices Directive and was not designated under the Active Implantable Medical Devices Directive nor the IVD Directive.

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