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 16, 2021

[FEATURED] EU Notified Body Association Takes Steps To Allay EC’s Virtual Audit Fears

The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.

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February 9, 2021

[FEATURED] Common Regulatory Starting Point Means EU-UK Are On Track For Medtech MRA, Say German Firms

With Brexit less than a month old, Germany’s medtech industry has renewed its push for an MRA between the EU and UK in medtech regulation.

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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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January 26, 2021

[FEATURED] First MDR Notified Body Designated In Finland As Nordic Numbers Nudge Up

The latest update in the Medical Device Regulation page of the European Commission’s Nando database represents the 18th listing under the new regulation. Numbers are rising slowly.

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