February 23, 2021

[FEATURED] EU Notified Bodies Advise Manufacturers To Think Hard About Regulatory Strategy Timings

Industry holding out for IVDR delay but fears resurface over MDR bottlenecks in 2023-24

Waiting until the grace period expires before making a product application under the EU MDR or IVDR is a gambit that could easily misfire, TEAM-NB warns.

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February 2, 2021

[FEATURED] Lobbying For A One-Year Delay To The EU IVDR: Solution Or Forlorn Hope?

The IVD Regulation is due to fully apply in May 2022. The necessary infrastructure looks unlikely to be ready in time. But industry faces a dilemma: will lobbying and pining hopes on a delay be the best use of its resources?

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December 29, 2020

[FEATURED] Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos

Latest EU survey predicts unprecedented hike in demand for notified body assessments between 2021 and 2024 and insufficient notified body capacity under the Medical Device Regulation.

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November 24, 2020

[FEATURED] Deadlines Needed For Urgent EU MDR Vigilance And Postmarket Surveillance Guidance Documents

Some 46 guidance documents still need to be drafted by the European Commission’s Medical Device Coordination Group before the EU MDR comes into force and time is running out, especially for post-market responsibilities.

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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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