IVDR Compliance Made Easy: The Importance of an IVDR Pre-Submission Assessment by MDx CRO
IVD news May 3, 2023What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment? Continue reading. The... read more
IVD Clinical Trials: The Do’s and Don’ts
IVD news April 26, 2023What are some of the most important things you’ll need to know for IVD clinical trials? Continue reading to learn... read more
IVD Software Development: How to Bring IVD Software to Market in 8 Steps
IVD news April 4, 2023The healthcare industry is undergoing a rapid transformation spurred by the advent of advanced medical diagnostic technology. IVD software development... read more
IVDR technical documentation guidance released by Team-NB
IVD news March 13, 2023If you are still undecided on which Notified Body (NB) to choose or you are in the early stages of... read more
What to Consider When Developing an IVD Clinical Performance Study for IVDR Compliance
IVD news March 9, 2023One of the critical steps in IVD development is the conduct of an IVDR clinical performance study to generate reliable... read more
MedTech Europe Releases 3rd Edition of eBook on IVDR Clinical Evidence Requirements
IVD news March 4, 2023MDx summarize the key updates to the MedTech Europe Regulatory eBook Clinical Evidence Requirements under the EU In Vitro Diagnostics... read more
The Impact of the IVDR and MDCG 2023-1 on LDT
IVD news January 12, 2023IVDR LDT / IVDR in-house devices On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices... read more
The future of in vitro diagnostics
IVD news November 2, 2022Although there has been a significant growth in recent years in the understanding of the crucial role that diagnostics play... read more
In the absence of EU Reference Laboratories, Class D measurements
IVD news October 13, 2022Team-NB produced a Position Paper on measures for class D IVD in the absence of EU Reference Laboratories as a... read more
Roche Ventana PD-L1 Assay Gets CE Mark as NSCLC CDx
IVD news October 5, 2022In a landmark announcement, Roche has revealed that its Ventana PD-L1 (SP263) Assay has received CE IVD approval, setting a... read more
EU Reference Labs
IVD news August 23, 2022The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories). Article 100(4) of Regulation (EU)... read more
Multiplex #IVD devices | Assessment Common Approach
IVD news August 23, 2022Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with... read more
Companion Diagnostic in Precision Medicine
IVD news 27 November, 202165% of EMA and FDA drug approvals involved a biomarker between 2015 and 2019. Currently, 44 CDx are approved by the FDA, and the most relevant categories in terms of the number of approvals are NSCLC and colorectal cancer.
