GMed Designated Under EU IVD Regulation
In the EU, there are now six EU notified bodies designated under the IVD Regulation.
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There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussions at the Council of the EU have now added to this drive.
Latest EU MDR notified body designation brings total in Italy to six, the same as Germany.
How One EU Notified Body Transitioned From The Directives To The MDR And What The Change Means For Clients
Less than two months after the MDR applied in the EU, GMED’s Tarik Krim explains how his notified body navigated the early phase of the transition from auditing the directives to the regulation, and how the change has impacted its clients and demand for services.