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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April 11, 2019

[FEATURED] IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU’s IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

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March 18, 2019

[FEATURED] Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

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MedTech Summit 2019

June 17-21, 2019

Crowne Plaza Brussels – Le Palace, Brussels

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