AN EU medical device expert advised manufacturers to avoid submitting applications at the last minute for approval under the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), as delays can create trouble and potential bottlenecks in obtaining certifications.
Gert Bos, the executive director and partner at Qserve Group, said that notified bodies are “screaming for work” and are laying off staff because there is not enough for them to do…
