EMA issues guidance on interaction with notified bodies on combination advanced therapies
This article was originally published in RAJ Devices
The European Medicines Agency has released for consultation guidance on how the agency's Committee for Advanced Therapies will interact with notified bodies when the committee assesses combination advanced therapy medicinal products that incorporate medical devices.
You may also be interested in...
In the EU, voices calling for a postponement of the IVD Regulation’s 2022 enforcement date are growing louder.
The designation of France’s GMed as an EU notified body will be a huge relief to the French medtech industry. Some 30% of the country's medtech sector, the second largest in Europe, uses its services.
The COVID-19 pandemic has made physical audits of manufacturers unsafe, and demand for auditing is set to reach its peak as the MDR application date looms. While some types of virtual audits are already allowed, others are not, leaving some device manufacturers in limbo.