BSI issues its first certificate for an IVD Companion Diagnostic (CDx) device under the IVDR

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Date: 10 May 2023

Full scope Notified Body BSI The Netherlands (2797) is pleased to announce the issue of its first CDx Certificate under the In Vitro Diagnostics Regulation (IVDR (EU) 2017/746).

The certificate is issued to Invivoscribe, Inc. for the LeukoStrat® CDx FLT3 Mutation Assay, a qualitative, PCR-based in vitro diagnostic test, intended to assist with making treatment decisions for patients diagnosed with acute myelogenous leukaemia (AML), with FLT3 ITD and TKD gene mutations.

Companion diagnostics (also known as CDx) is a particular category of IVD devices, used to aid in the assessment of patients for whom a specific drug therapy is being considered, and hence play a big role in personalized medicine. The IVDR has increased requirements for CDx.  Most CDx devices are now in risk Class C and require Notified Body oversight for placement on the market. In addition, a Notified Body is required to consult the competent authority designated by the member states in accordance with Directive 2001/83/EC or the European Medicines Agency (EMA) as applicable, which results in a longer approval process.

Dr Elizabeth Harrison, Global Head of IVD at BSI comments, “IVDR certification of safe and compliant companion diagnostic devices is crucial to ensure patients in Europe have access to state-of-the-art precision medicine. Issuance of this certificate shows that the IVDR regulatory infrastructure for certifying these devices is functioning and that Notified Bodies and Medicinal Product Authorities have capacity to conduct the reviews. Manufacturers of companion diagnostic devices should progress their Notified Body applications to allow smooth transition to the Class C deadline of 26 May 2026”.

“Invivoscribe is very pleased that our LeukoStrat® CDx FLT3 Mutation Assay received the first IVDR certificate granted for a CDx by BSI. This accomplishment is the result of a years-long team effort by members of the company and demonstrates the quality and strength of our CDx and quality management systems,” said Jeffrey Miller, Invivoscribe’s CSO and CEO.

BSI The Netherlands (2797) is a leading full scope Notified Body designated under the IVDR and MDR. We are also a full scope UK Approved Body (0086) assessing medical devices against UK legislation. We review your IVD medical device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to the market. With an average of over 20 years of combined experience, our IVD Team has a broad range of industry and regulatory knowledge allowing us to conduct devices reviews covering over 80 NBOG codes.