Eucomed raises objections to EMA combination guidance involving notified bodies
This article was originally published in RAJ Devices
The European Medicines Agency's proposed revised version of its guidance concerning the CE marking of drug/device combination products will not improve the length of the procedure nor the related costs, says European medtech trade association Eucomed1.
You may also be interested in...
The EU is pulling out all the stops to have the one-year delay to the MDR adopted before it is too late, and a crucial vote will take place on 16 April.
Virtual notified body audits of medtech manufacturers are already taking place through necessity. Now there is guidance concerning if, when, where and how these audits should be carried out.
Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination product. A new position paper explains how roles and responsibilities are shared between medtech and medicinal product experts.