European Commission Extends Time IVD Companies Can Use Lead In PVC Sensors
No adequate substitution of lead in specific sensors means that some IVDs will remain exempt for now from the EU Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment (RoHS)
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The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.
The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?
There are now 41 notified bodies in total under the EU’s Medical Device Regulation.