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
What you need to know about new submission process for Clinical Investigations in Spain with the AEMPS
MEDTECH news February 13, 2023Since the implementation of the new EU MDR, there has been significant standardization in the processing of clinical investigation submissions... 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
WHO Guidance for Digital Health Nov 2022: Monitoring the implementation of digital health
SOFTWARE news November 23, 2022In recent years, there has been a dramatic increase in the use of digital health tools health in order to... read more
Understanding MDCG 2020-10 Rev 1: Safety Reporting in Medical Device
MEDTECH news November 21, 2022In light of the forthcoming Medical Device Regulation (MDR) and the delay in the complete functionality of the electronic system... read more
MedTech Europe urges parliamentarians assess the challenges of the EU MDR 2017/745
MEDTECH news November 9, 2022Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to... 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
Clinical Evaluation Consultation Procedure (CECP)
MEDTECH news October 24, 2022This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical... 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
Position paper on cyber security
MEDTECH news October 13, 2022This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a... read more
Data produced by ‘Off-Label’ Device Use in accordance with EU Medical Device Regulation 2017/745
MEDTECH news October 13, 2022The Mirror-MDCG-Clinical Working group, which includes members of 11 NBs, created this position paper. It was distributed to all NBs... read more
New Team NB Position Paper | Best Practice for Submission of EU MDR Technical Documentation
MEDTECH news October 7, 2022To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the... 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
Draft of Principles and Practices for Software Bill of Material for Medical Device Cybersecurity
SOFTWARE news August 23, 2022Due to the usage of shared software components, #cybersecurityvulnerabilities may affect a wide variety of apparently secure unconnected products from... read more
IMDRF Machine Learning-enabled Medical Devices: Key Terms and Definitions
SOFTWARE news June 3, 2022The main purpose of this new guidance t is to create uniform expectations and understanding for Machine Learning-enabled Medical Devices... 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.
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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