TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?
Increased transparency is often highlighted as one of the major steps forward in the new EU Medical Device and IVD Regulations. But based on discussion at a Feb. 27 European Parliament committee meeting, some feel the changes do not go far enough. Is more debate needed?
Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the new EU Medical Device and IVD Regulations, and they spell out some of the challenges companies have encountered during a panel discussion at the recent LSX World Congress in London.