IVDR Application Foot-Dragging by Devicemakers Shown in Team NB Survey

A survey conducted among attendees of Team NB’s second in vitro device regulation (IVDR) training seminar reflected the worrisome trend of foot-dragging among manufacturers in making an application to a Notified Body for approval of devices under the new EU medical device regulations.

Slightly more than half (51 percent) of attendees said they had not yet sent in an IVDR application to a Notified Body. Large manufacturers were more likely to say they had (64 percent) but only 38 percent of small and medium manufacturers said they had applied.

In a strongly worded position paper, the European Commission’s Medical Device Coordination Group (MDCG) has directed device manufacturers to get certified ASAP under the new device and diagnostics regulations.

Read the Team NB training announcement here.

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