EU Designates 17th Notified Body Under MDR
Despite COVID-19 distancing measures and fears that new notified body appointments would grind to a halt, there is now a new notified body for the EU Medical Device Regulation.
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With the EU having now announced 20 notified body designations against the EU’s Medical Device and IVD Regulations, some clear patterns have emerged. But the Commission denies any bias.
Despite industry’s urgent need to have their products assessed by notified bodies under the MDR, appointments are coming through slowly.
Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.