What is the Regulatory Process for IVD in Europe?

What is the Regulatory Process for IVD in Europe?

IVD news May 10, 2023

What is the regulatory process for IVD in Europe, and which are the most important aspects of it? Continue reading to learn more. The In Vitro Diagnostic (IVD) market in Europe is regulated by a complex framework, and understanding the... read more

IVDR technical documentation guidance released by Team-NB

IVDR technical documentation guidance released by Team-NB

IVD news March 13, 2023

If you’re still undecided on which Notified Body (NB) to choose or you’re in the early stages of development, Team-NB has just released this best practice guidance Guidance for the Submission of Technical Documentation under Annex II and III of... read more

The Impact of the IVDR and MDCG 2023-1 on LDT

The Impact of the IVDR and MDCG 2023-1 on LDT

IVD news January 12, 2023

On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has become fully applicable with major consequences not only for manufacturers of IVDs but also for all diagnostic laboratories, particularly those that manufacture in-house... read more

The future of in vitro diagnostics

The future of in vitro diagnostics

IVD news November 2, 2022

Although there has been a significant growth in recent years in the understanding of the crucial role that diagnostics play in European healthcare, diagnostics firms still confront numerous difficulties in the design, development, funding, regulation, and adoption of new products.... read more

EU Reference Labs

EU Reference Labs

IVD news August 23, 2022

The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories). Article 100(4) of Regulation (EU) 2017/746 specifies the requirements that must be met by EU reference labs. In order to assure adherence to these standards,... read more

Multiplex #IVD devices | Assessment Common Approach

Multiplex #IVD devices | Assessment Common Approach

IVD news August 23, 2022

Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with their sole intended purpose. They may be intended to detect dozens of targets/markers, such as allergies or microorganisms. Due to... read more

Companion Diagnostic in Precision Medicine

IVD news 27 November, 2021

65% 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.