November 17, 2020

[FEATURED] IVDR Implementation Not Yet On Track: What The Diagnostics Sector Needs To Do

The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.

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November 2, 2020

[FEATURED] EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies

Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?

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June 10, 2020

[FEATURED] Why The EU Urgently Needs A One-Year Delay For The IVDR And EU-Wide Exceptions For IVDs

The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from usual medical device rules was granted recently. But not for IVDs, where the situation is described as “grim.”

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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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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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