Bottleneck of bottlenecks for notified body capacity

People that are downplaying the notified body bottleneck may need to start to revisit their position with notified body LRQA now also dropping out of the notified body pool for medical devices and IVDs. This is especially a problem with respect to IVDs, as LRQA is one of the notified bodies traditionally handling a large share of the currently CE certified IVDs in the EU. This expertise and capacity will now be lost and not be available for the IVDR transition and for soft transition under the IVDR. And the [...] « Read the rest of this article on medicaldeviceslegal »