This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR).
The SVR is a critical component of the IVDR in that it establishes the association of the analyte with the clinical condition or physiological state. Regulators expect manufacturers to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged as SOA. To establish that your IVD reflects the current best-practice, you must be able to show how it fits into the entire scientific landscape and explain the circumstances and diagnostic scenarios by which the IVD can be considered SOA. Here, we discuss the critical role of the SVR in establishing SOA as it relates to the overall performance evaluation process.
The SVR is your chance to …
Download the rest of this white paper here.
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In the EU, there are now six EU notified bodies designated under the IVD Regulation.
French notified body, GMed, has been designated under the IVD Regulation for a comprehensive scope of products.
This brings the total number of IVDR notified bodies to six. The latest designation comes with just nine months to go until the regulation fully applies from 26 May 2022.
New EU guidance tells notified bodies they must wait to issue a certificate for a high-risk IVD in cases where a similar product is under review by an expert panel.
The regulation and requirements for companion diagnostics will be far stricter under the IVDR than the current IVD Regulation. EU life sciences regulatory lawyer Elisabethann Wright provides an overview and explains how companies should prepare for compliance.
Click here to watch the recording of this webinar.
In this practical presentation, Criterion Edge presents focused strategies on building an IVDR-aligned State of the Art (SOA) section within the Scientific Validity Report (SVR). We also talk about the critical role of the SVR as it relates to the overall performance evaluation process.
Key Takeaways:
Who Should Watch:
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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