ARTICLE SUMMARY:
More than half of the 501 device firms responding to an EU government survey said less than 10% of their product portfolio requiring MDR certification had reached that milestone, although more progress is planned and the pace of MDR/IVD CE marks granted by notified bodies is increasing.
There is still a long way to go for companies transitioning their product lines to Medical Device and IVD Regulation compliance, but the pace of notified body certification activity is continuing to accelerate. Those are takeaways from the latest response data from an ongoing European Commission survey intended to gauge device availability under the new regulations. It’s the first set of data reported from the survey that was collected from device manufacturers—up until now, the research have spotlighted feedback from notified bodies.
Researchers from the Austrian National Public Health Institute (Gesundheit Österreich GmbH), which has been commissioned by the EU to periodically survey and compile data from device stakeholders since December 2022, presented the latest findings to the EU Medical Device Coordination group during its April 24 meeting. MDCG recently posted the group’s slide presentation to its website.
