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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December 21, 2021

[FEATURED] EU’s First IVDR Expert Panel View Published

The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.


The IVD Expert Panel, set up in the context of the EU’s IVD Regulation, has issued its first opinion based on a manufacturer performance evaluation report submitted by a notified body.

The seven-page document has been published on the website of expert panels on medical devices and in vitro diagnostics (Expamed) and is a review of a hepatitis E virus (HEV) test.

The advice is provided in the context of the performance evaluation consultation procedure (PECP), which is an additional element of conformity assessment by notified bodies for specific high-risk in vitro diagnostic devices (IVDR Article 48.6).

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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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[Free Webinar] Ask the Expert: Clinical Evaluation Report Critical Concepts

Join us on Wednesday October 10th, 2022 at 11AM PST / 2PM EST, as President Laurie Mitchell answers your questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. Learn best practices and writing strategies to support solid planning during your own writing process.

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