First Belgian Notified Body Appointment Brings EU MDR Total To 25
Every new notified body designation under the Medical Device Regulation is being welcomed by medtech companies as the countdown continues for the grace period to end in May 2024.
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.