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[FEATURED] No Need For UDI On Some Drug/Device Combinations In The EU
While UDI will be required on all products that come under the scope of the EU’s medical device […]Read More[FEATURED] Notified Body Q&A: 3 NBs Talk EU MDR Enforcement, The IVDR ‘Big Bomb,’ ‘Tough’ Regulators – And More Insights
MEDCERT’s Klaus-Dieter Ziel, TÜV SÜD Product Service’s Bassil Akra and Qserve Group’s Gert Bos answered questions about the EU’s […]Read MoreEU Officially Designates Second Notified Body Under The MDR: TÜV SÜD Enters Center Stage
TÜV SÜD, headquartered in Germany, is the second notified body to be officially designated under the EU MDR. […]Read More[FEATURED] EU MDR Transparency Not Enough: Time For A Big Debate?
Increased transparency is often highlighted as one of the major steps forward in the new EU Medical Device […]Read More[FEATURED] The Cost And Complexity Of Implementing The EU Medical Device And IVD Regulations
Three experts talk about what it takes logistically for medtech businesses to prepare for timely compliance with the […]Read More