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.
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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.
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.
How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges
A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.