FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

More Notified Bodies Give Up on EU MDR/IVD Certification

June 25, 2019
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The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t be offering certification.

Swiss notified body QS Zurich has announced it will no longer pursue NB designation for the new regulations but will continue to certify for ISO 13485. The announcement came just a week after London-based Lloyd’s Register Quality Assurance (LRQA) said it would not offer its NB services under the new regulations.

“Following recent market developments, we have made the strategic business decision to exit from [notified body certification] services,” LRQA said. “We are also withdrawing our application to become a Netherlands-based EU Notified Body for these services” and will not be applying to become a Notified Body for MDR or the in-vitro diagnostic devices regulation.

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