June 21, 2022

[FEATURED] Pew Responds To Draft Legislation Creating Regulatory Oversight Of Lab Developed Diagnostics

The time to create a flexible, risk-based regulatory system for all in vitro diagnostics is now, Pew tells US lawmakers, and offers suggestions to improve draft legislation that aims to do just that.

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June 6, 2022

[FEATURED] EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency

In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.

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May 30, 2022

[FEATURED] Risk Management Update Published Within Days for EU MDR Use

Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.

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May 23, 2022

[FEATURED] Device/Drug Borderline: Gray Areas Remain Despite New EU Guidance

New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.

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May 16, 2022

[FEATURED] EU’s Risk Management Standard Officially Recognized In Context of the IVDRU

Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.

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