MDx summarize the key updates to the MedTech Europe Regulatory eBook Clinical Evidence Requirements under the EU In Vitro Diagnostics... read more
Since the implementation of the new EU MDR, there has been significant standardization in the processing of clinical investigation submissions... read more
IVDR LDT / IVDR in-house devices On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices... read more
In recent years, there has been a dramatic increase in the use of digital health tools health in order to... read more
In light of the forthcoming Medical Device Regulation (MDR) and the delay in the complete functionality of the electronic system... read more
Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to... read more
Although there has been a significant growth in recent years in the understanding of the crucial role that diagnostics play... read more
This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical... read more
Team-NB produced a Position Paper on measures for class D IVD in the absence of EU Reference Laboratories as a... read more
This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a... read more
The Mirror-MDCG-Clinical Working group, which includes members of 11 NBs, created this position paper. It was distributed to all NBs... read more
To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the... read more
In a landmark announcement, Roche has revealed that its Ventana PD-L1 (SP263) Assay has received CE IVD approval, setting a... read more
The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories). Article 100(4) of Regulation (EU)... read more
Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with... read more
Due to the usage of shared software components, #cybersecurityvulnerabilities may affect a wide variety of apparently secure unconnected products from... read more
The main purpose of this new guidance t is to create uniform expectations and understanding for Machine Learning-enabled Medical Devices... 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.
Deep learning techniques using neural networks are used in medical devices to fulfill human capabilities in a variety of roles, such as: Disease prediction, detection, classification, and analysis.
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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