August 2, 2018

[FEATURED] Commission’s Draft EU Standardization Request May Overwhelm Tech Committees At 11th Hour

A great many EU medtech standards may not be ready in time for manufacturers to demonstrate compliance with the new regulations when they apply in 2020 and 2022. So, what is happening?

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July 18, 2018

[FEATURED] EU Regulatory Reads, June 2018: Experts Tell Industry To Get Moving Despite Shortfalls – Shift Later!

Pressure is building on companies to start compliance efforts to the EU Medical Device Regulation. But a good deal of naivety remains in industry, and those who delay may lose out badly, experts warned in Medtech Insight articles throughout the month of June.

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July 3, 2018

[FEATURED] New Reasons Not To Use EU MDR’s Four-Year Extension, But Comply Earlier Or Retire Products Instead

The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.

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June 20, 2018

[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?

Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to notified bodies?

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May 4, 2018

[FEATURED] Does EU Regulation Of 3D-Printed Implants Expose Gap In MDR Regime?

“Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU Medical Device Regulation does not specifically regulate it, and there may be easier routes to compliance than companies think, according to attorney Joerg Schickert.”

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