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.

Do you like it?0
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.

Do you like it?0
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.

Do you like it?0
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.

Do you like it?0
May 2, 2022

[FEATURED] Against The Odds: Notified Bodies Pinpoint The Real Obstacles And Ways To Move Past Them

With demand for EU notified body medtech services fast outstripping capacity, three well-known notified body experts explain how they are battling to make the new regulatory system work.

Do you like it?0