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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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.
The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.
While it was obvious to those in the sector that the implementation of the EU IVD Regulation was heading for a disaster, this article looks at the facts and figures that helped sway the European Commission to propose new transition periods to better manage its implementation.