EU MDR Notified Bodies Reach 38 After Another Designation
Germany’s SZUTEST is the latest notified body to be designated under the EU Medical Device Regulation, bringing the total number to 38.
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Another Hiatus In Notified Body Designations Ahead
It is not uncommon for notified bodies designations to appear sporadically. There had been a nine-month gap in IVDR listings until May 2022. Recent EU figures herald another quiet period for medtech in general.
Another Notified Body Designation Coming Down The Line Under The EU MDR
With two IVD Regulation notified body designations in the last week, there should be one more notified body listed under the Medical Device Regulation designation shortly. But then there is likely to be a gap.
Total Number Of IVD Regulation Designations Reaches 10
Two EU IVDR notified bodies have now been designated this week. NSAI of Ireland has been designated as a notified body under the IVD Regulation, the tenth under the EU’s IVDR, and is specializing in self-testing.