The field of personalized medicine is experiencing notable progress as BSI and TÜV SÜD, two of the largest Notified Bodies in the European Union, have issued their first Companion Diagnostic (CDx) Certificates under the In Vitro Diagnostics Regulation (IVDR). This... read more
Are you ready for the new regulation on In Vitro Diagnostic medical devices in Spain? Learn everything you need to know about it. The in vitro diagnostic medical device sector plays an important role in healthcare by providing instruments and... read more
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
What are the most important things you’ll need to know when it comes to IVDR pre-submission assessment? Continue reading. The In Vitro Diagnostic Regulation (IVDR) is a new regulation that took effect on May 26, 2022, replacing the In Vitro... read more
What are some of the most important things you’ll need to know for IVD clinical trials in 2023? Continue reading to learn more. In-vitro diagnostics (IVD) are tests performed on biological samples, such as blood or tissue, to diagnose or... read more
The healthcare industry is undergoing a rapid transformation spurred by the advent of advanced medical diagnostic technology. IVD software development is a critical component of this revolution as it allows for testing, analysis, reporting, and communication without needing a physical... read more
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
One of the critical steps in IVD development is the conduct of an IVDR clinical performance study to generate reliable and meaningful data to support regulatory approval and the device’s commercial success. In Europe, the in-vitro diagnostic regulation (EU IVDR)... read more
MDx summarize the key updates to the MedTech Europe Regulatory eBook Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR) Version 3, published in February 2023, emphasizing the relevance of the CDx, clinical performance studies, similar/equivalent concepts, and... read more
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
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
Team-NB produced a Position Paper on measures for class D IVD in the absence of EU Reference Laboratories as a result of the IVD working group’s efforts. During the General Assembly meeting, a sizable majority of the members approved the... read more
To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practice guidance documents that each Team NB notified body member had submitted. They then prepared this best practice guidance... read more
Roche announced on Friday that the Ventana PD-L1 (SP263) test has been CE marked for use in patients with lung cancer who are taking Regeneron’s Libtayo (cemiplimab). The goal of the test is to identify non-small cell lung cancer (NSCLC)... read more
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 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
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.
MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.
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