July 13, 2021

[FEATURED] Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users

Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be made available.

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April 27, 2021

[FEATURED] High-Risk Class D IVDs: Some Good News, Some Bad News About IVDR Implementation

The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.

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April 20, 2021

[FEATURED] Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave

The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”

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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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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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