Two MDR-Designated European Notified Bodies Become One
Norwegian notified body DNV acquires German competitor in move intended to address the peak in Medical Device Regulation certification demands.
You may also be interested in...
Manufacturers of COVID-19 tests may now have longer to comply with the IVD Regulation. But those from third countries need to be aware of the deadlines and hurdles ahead and act now.
The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.
The scale of responsibilities for a virtual manufacturer under the EU’s new Medical Device and IVD Regulations may deter many companies from taking on this role. Elisabethann Wright, partner at Cooley law firm, explains why.