October 20, 2022

[FEATURED] EU Proposal To Have Guidance Transition Periods “Does Not Make Sense”

A proposed position paper on time periods for notified bodies to roll out guidance documents aims to introduce greater predictability. But has the EU notified body organization gone too far with its proposals?

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October 15, 2022

[FEATURED] FDA Publishes Final Guidance On Clinical Decision Support Software, Clarifies What Software Should Be Regulated As Medical Devices

In its final document, the US FDA outlines its interpretations of the four criteria for excluding clinical decision support software from being regulated as medical devices under federal law. Software must meet all four criteria to be excluded.

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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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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The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn.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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