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Qlucore Newsletter: Importance of Using IVDR Compliant Diagnostic Tests

Are your clinical tests compliant with the In Vitro Diagnostic Medical Devices Regulation (IVDR)? 

Do you know if your laboratory is compliant with regulatory requirements? You must ensure that the clinical test you are using for diagnosis is indeed IVDR-compliant. This is not only a requirement, but it will also allow you to maintain the highest standards of patient care.

A central aspect of regulatory compliance is that products and solutions are developed and maintained using a Quality Management System (QMS). If you are not using CE-marked solutions, a good start is to read Chapter 3.5.2 in MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. This document outlines the comprehensive requirements for a QMS to ensure the safety and performance of in-house devices under IVDR. 

Patient Safety: 
IVDR-compliant tests ensure high safety and performance, reducing the risk of inaccurate results. Importantly, it also offloads the organization of time and effort in managing a QMS and performing required verifications and validations. 

Legal and Operational Risks: 
Non-compliance can lead to legal issues, fines, and operational disruptions. 

QMS: 
A robust QMS is essential, covering aspects outlined in Article 10(8) of the IVDR. 

Key Areas of Focus for IVDR Compliance: 

  • Adhere to standards 
  • Manage resources and documentation 
  • Maintain risk management 
  • Justify in-house tests 
  • Keep records 
  • Ensure identification and tracking 
  • Review clinical use 
  • Communicate with authorities 

At Qlucore, we have reached the final stage of CE-certification for Qlucore Diagnostics 1.0, which means that the QMS at Qlucore is audited according to ISO 13485:2016. Our first product will focus on pediatric leukemia (BCP-ALL) and will be available to clinical laboratories across Europe by early spring 2025. 

Qlucore Diagnostics

Join our webinars in January to get an introduction to Qlucore Insights, our RUO tool for disease subclassification analysis for frontline research. 

23rd: Transcriptomics for molecular classification of Lung Cancer 

30th: Transcriptomics for molecular classification of Acute Lymphoblastic Leukemia

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