July 15, 2019

[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 regulations, what is the situation for drug/device combinations? The answer is not simple, and depends on an often-tricky regulatory assessment.

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July 2, 2019

[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 new Medical Device and In Vitro Diagnostic Regulations at MedCon 2019.

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June 13, 2019

EU 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. Is this good news going to significantly lessen medtech industry’s concerns over delays in accessing the new, tougher regulatory system for medical technology, with time running seriously short?

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May 29, 2019

[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 and IVD Regulations. But based on discussion at a Feb. 27 European Parliament committee meeting, some feel the changes do not go far enough. Is more debate needed?

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May 11, 2019

[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 new EU Medical Device and IVD Regulations, and they spell out some of the challenges companies have encountered during a panel discussion at the recent LSX World Congress in London.

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