January 25, 2022

[FEATURED] Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions

The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.

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January 13, 2022

How to Establish the State-of-the-Art Within the Scientific Validity Report

How to Establish the State-of-the-Art Within the Scientific Validity Report

In this presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation process. In addition, you will learn how to assess your SVR project for unanticipated roadblocks and delays. Finally, you’ll see how indecision or incomplete supporting documents can negatively impact SOA (and therefore, SVR) quality and timelines. 

Key Takeaways: 

  1. The foundational role of the SOA in the SVR 
  2. The required components of the SOA such as the safety and performance objectives 
  3. The importance of a robust systematic literature review (SLR) to support your SOA 

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are develop, write, review, or approve of Performance Evaluation Reports for EU IVDR submission. Anyone interested in learning more about IVDR requirements for PERs is encouraged to attend as well.

Click here to watch the recording of this webinar.

A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.

In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). Watch this webinar.

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January 4, 2022

[FEATURED] Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States

There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussions at the Council of the EU have now been added to this drive.


European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.

So far, there are just six notified bodies designated under the IVDR.

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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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November 16, 2021

[FEATURED] Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap

The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.


The urgency of having the necessary structures in place, including notified bodies, so that manufacturers can comply with the IVD Regulation, continues to be emphasized by all stakeholders in the EU IVD sector.

Accompanying this is a general sense that there has been a lack of transparency about when additional designations will be made, which hinders companies’ preparations.

The latest figures from the European Commission show that progress is being made, but not as quickly as the sector would like.

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