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.

Do you like it?0
May 9, 2022

[FEATURED] EU IVD Regulation: Guidance on Significant Changes Now Available

With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs.

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
April 24, 2022

[FEATURED] Updated: New MDR Notified Body Designations Pending, But Only One Under IVDR Until Late 2022

Latest figures published by the European Commission show some progress can be expected soon when it comes to notified body designations under the Medical Device Regulation, but very little under the IVD Regulation.

Do you like it?0
April 11, 2022

[FEATURED] European Regulatory Roundup, March 2022: Unprecedented Hiatus In Implementation Announcements

Unprecedented silence from the EU when it comes to news relating to the implementation of the Medical Device and IVD Regulations is disconcerting as compliance pressures mount.

Do you like it?0